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On average, sponsor companies invest between $1 billion and $3 billion in ushering a new drug to market. As they progress to the final and pivotal trial before submission to regulatory authorities, the stakes heighten, approval looms closer, and undoubtedly, logistical intricacies multiply. During this phase, planning typically revolves around recruitment challenges and local approvals, but an often overlooked yet significant hurdle emerges: the so-called “last mile”. In the past, the last mile primarily focused on ensuring the successful delivery of IP to sites. However, in today’s decentralized clinical trials (DCT) landscape that increasingly includes provisioned devices (phones and tablets), wearable sensors, and electronic Clinical Outcome Assessments (eCOA). The final mile now hinges on the flawless deployment of a myriad of devices, sensors and associated materials. Timely delivery of properly functioning equipment, ensuring user comprehension of how to operate the systems and equipment coupled with an on-site management strategy becomes pivotal for the success of the study. This spans across recruitment, retention, adherence to the protocol, and, ultimately, the ability to capture clinical research data If you are an investigative site, the last mile described above is your first mile. While much of the schedule of visits will depend on equipment you already have, the work and planning to get IP and logistics to your site is really what allows you to enroll your first patient. However, additional devices, whether they are used to collect consent or clinical measurements, assess patient satisfaction, track daily drug usage, etc, can come from an ever-evolving number of providers and often must also be on hand before a patient can be enrolled. How can you, the site community, cope with this challenge? The challenges of technology that the site faces are multifaceted: a single study will utilize 8 or more different applications or portals. The site staff must train on each of these, in addition to the 4 systems that many sites already use for their standard workflow such as eSource, eReg, CTMS, email, and patient payment portals. Technology usage aside, logistics such as planning and accounting for the wearables and devices is an overlooked and sometimes overwhelming requirement for study teams. For example, when Rochester Clinical Research (RCR) receives a shipment of devices, often there are NO identifiers as to the protocol, sponsor even the PI on what the devices are intended to be used for. A guessing game ensues. Sites need to find a secure location that has numerous power outlets available for charging. Being advised to monitor the device so they are not left charging is simply not a feasible option for sites. There is often “rationing” with just-in-time delivery of the devices and lengthy delays in re-supplying the devices at high-enrolling sites. The alternative of having participants use their own devices solely for the trial can create additional challenges of data plans, wifi availability, etc. As you contemplate a study that likely or definitely will include devices and wearables, here is a set of suggestions on items to consider or plan for to support a successful study. 1. An Ounce of Prevention Planning for the use of devices and sensors should start in advance of the study. The use of devices and sensors will have an impact on your budget as well as other considerations during the trial. If possible, ask for a list including the quantity of devices and sensors that will be shipped to the site. Other things to consider include: Will they be shipped just in time or in bulk (which will require storage)? Will you be expected to retain the packaging until the end of the study (which will require storage) or can you discard it? If the study is relying on patient devices to bring their own devices (BYOD), will backups be provisioned (which will require storage)? Will devices need to be updated in any way after receipt? On occasion, technical solution providers will deploy an application or web-based updates after the equipment is shipped. What are your local IT security standards? Will they allow for these devices to be used with your WiFi? What is the cellular data reception like in your location? What about your participants? Do you foresee any challenges with poor service? Devices may have to be replaced during the study if the duration is longer than the warranty or useability of the device. Understanding these items will allow you to consider if storage is available and to put it into your study budget and ensure devices are ready for participant use. Recognize that provisioned devices may be a different Make/Model/operating system than the participant is familiar with and this may impact their acceptance or interaction with the tasks required of them. Be prepared to walk the participant through the basics of using said device such as charging, button placement, and how to use basic features. This will help participants get started without experiencing friction later. Concerning BYOD devices, ensure that the technology can be used with their specific model and operating system. While you are planning, also consider how much you understand about your current patient population or the volunteers in your patient database. Do they have smartphones already? Do they have wifi at home and are their data plans sufficient for trial participation? If they are someone new to technology, do they live with someone who might be able to help them navigate some basic instructions? Knowing this will help you also plan for what time may be required to support the participants. Not all study participants have a smartphone or unlimited data plans. 2. Training Training is a hot topic right now. SCRS has collected feedback to show some of the increased burden that sites have experienced as a result of new technology. While it is time-consuming, if you can, track the time that the standard training takes per device or log in. Identify if previous training can count towards future use or if each study will require you to repeat essentially the same course. Use this data to plan your budget and provide the information to the sponsor or CRO in advance. You never know when the site experience may inform the study team’s final decision on what technology to use. 3. Adoption Data from Medable’s Site Adoption team shows a surprising trend. It’s often “getting started” that has caused the most calls to the help desk amounting to approximately 60% of all support tickets. This includes completing training, getting your credentials logging in, and taking the first basic steps in the system. Once a coordinator has gotten exposed to new tech, they are far more comfortable integrating and supporting technology and the inquiries to the help desk dramatically decline. However, it also happens that devices arrive and they don’t work as promised. Inquire about what support will be provided and how, both before study start and during your site’s participation, knowing that will help you develop a budget but also a resourcing plan for support, while also minimizing the inconvenience and frustration felt by your site staff and participants. 4. Taking Inventory of Your Team Another way to cope with the challenges that accompany the logistics around integrating tech is to understand who within your organization is best suited to provide support. At Rochester Clinical Research (RCR), they created a role specifically designed to assist their seasoned coordinator and PI staff through the use of a digital native. This role is aimed at professionals who want to work in research but came of age during the digital era. They are not replacing paper in their workflow because their education or first jobs didn’t require the use of paper. RCR learned firsthand that the digital native skill set was different than those who were even just a few years older. When faced with technology created quickly during large volume trials in the middle of the pandemic, RCR had to pivot quickly to be able to utilize the patient-facing technology. They created a role for digital natives to assist the study participant with the diary devices, the engagement specialists helped the subjects create an email address, access the app store, set pins, and be on call to troubleshoot since critical data was being lost due to participant challenges with the technology and poor help desk assistance. Essentially, they created their helpdesk to ensure compliance and decrease frustration for both staff and subjects. Not all sites will be able to do this nor should they have to, but for the participant to be successful, expanding the role and responsibilities of the study team to include this type of support, may be necessary. 5. The Role of Technology Providers How do you prepare and test devices before deployment? Do you have an optionto use your site’s own devices rather than a study-specific device and can you specify this at SSV? Tracking, both for inbound shipments and returns, but also for equipment at site. How is one tablet distinguishable from another? Recommend study-specific labeling to your CRO/sponsor. Devices frequently arrive without any identifiers as to sponsor, protocol, CRO, or even PI. Return Logistics: couriers will often not specify a time for collection; how can you work to support the site in terms of planning? Ensure that all importer of record paperwork is completed correctly with cross-border returns. Safety and storage of Lithium Ion battery powered devices: never leave indefinitely connected to a charger to avoid the risk of overheating and/or fire. New technology brings promise and opportunity, but the impact on the site workflow needs to be considered. Let us know what aspects of device and sensor management you all have found to be the most challenging and any suggestions for improvement. Take Medable’s survey on devices and wearables at the site level. By Carl Franzetti, Technology Operations, Medable Mary Costello, Site Evidence, Medable Pat Larrabee, Founder, Rochester Clinical Research

At clinical study sites, technology can be both a boon and a burden. When implemented well, technology solutions help staff to be more engaged with patients and more effective in their work. But that work can also be hindered by less-than-optimal approaches to technology. When site professionals discuss technology-related burdens, we hear most often about: Duplicative technologies, which lead to wasted time and frustration. Insufficient user acceptance testing, so sponsors miss out on end-user input from the site staff who will use the solutions in the field. A lack of adequate support from service provider help desks. Across-the-board training requirements that result in seasoned site staff repeatedly participating in rudimentary education. So when it comes to technology, how can sponsors and CROs be better partners to their sites? Consider site preferences for technology systems. Sites often invest in technology solutions, such as an eConsent platform, that staff learn thoroughly and use across studies. When sponsors and CROs insist on different software for specific trials, site staff must master new platforms and processes—a time-consuming and redundant task. When sponsors accept and adopt site-selected technology solutions, they benefit from the time and resources sites have invested in those platforms. Staff feel a sense of ownership in the system and gain proficiency that only increases as studies progress. That proficiency and institutional knowledge help curb protocol deviations that result from technology failures. By adopting a site’s technology, sponsors and CROs will benefit from greater efficiencies throughout a study. Because clinical trial solutions are designed for interoperability, sponsors and CROs that share their APIs make site partners more effective in their work. They also strengthen the sponsor-site relationship. Prioritize user acceptance testing. Before site staff begin using study software to enroll patients and capture critical data, sponsors and CROs should prioritize user acceptance testing. This gives sites the opportunity to provide feedback on technology readiness and reliability and allows sites to familiarize themselves with technology before introducing solutions to patients. Once sites offer their feedback, technology providers must be willing to address concerns through product updates. This process could be built into contracts, with sponsors and CROs requiring that technology partners offer satisfaction surveys at sites and report the results. Vendors would then be asked to develop and follow a plan to mitigate user-reported issues. Expand technical support. We have heard from our site partners that service provider help desk techs are often unfamiliar with the clinical aspects of study protocols. Help desk support is also often available only during business hours, even for sites that see patients in the evening or on weekends. To bridge this gap, sites should have access to a sponsor-affiliated expert with deep knowledge of both the protocol and the systems and who can serve as a liaison between site staff and service providers. Sponsors and CROs could also provide training so support techs better understand the clinical requirements of a trial and how those requirements impact the ways their software will be used. Make training requirements more flexible. To demonstrate site staff competency, sponsors and CROs often resort to requiring even experienced professionals to complete rudimental technology training. Often, training courses are designed as if every staff member is research-naïve. Site staff frequently tell us that required training does not meaningfully improve their performance. It does, however, divert focus from their core responsibilities. In the 2023 Site Landscape Survey, the Society for Clinical Research Sites (SCRS) surveyed its members regarding training requirements. Forty percent of respondents reported that, on average, each site staff member spends five to 15 hours on training per study, while 25 percent of sites say they spend between 15 and 20+ monthly hours on training per person per study. When developing training requirements, sponsors and CROs should be working from a strategy. If the aim is to impart knowledge, they need to know what kinds of education would be most valuable to the site staff. If the goal, however, is simply to prove to regulators and others that site staff are competent and qualified to perform their duties, such demonstration can be accomplished through means other than mandatory training. For example, site staff would welcome the chance to self-attest to technology competence to fulfill competency requirements. 40% of sites said each site staff member spends 5-15 hours on training per study. When selecting clinical trial technologies and creating policies around their use, sponsors and CROs are learning to consider more fully the needs of study sites. As we reduce technology-related burdens, we will free site staff to focus on their core mission. As a result, these professionals can spend more time recruiting and serving patients, using systems that they understand well and trust to be reliable. All of this can lead to faster startup and fewer protocol deviations. It also helps site staff feel valued by their study partners, which can positively impact productivity and performance. As sponsors and CROs, we select sites based on their experience and demonstrated capabilities. Remembering that, we need to take advantage of expertise within the sites, allowing site staff to contribute to decisions about technologies. Site expertise should also be a factor in determining training requirements, which should be customized based on staff experience. By including sites in technology strategy, sponsors and CROs can select systems and processes that best serve the entire study team. By Karen McIntyre, Vice President of Global Site Alliances, Parexel

As we embark on a new year filled with predictions, let’s take a closer look at what’s here to stay in the world of clinical research. The new year always brings about future-oriented visions for the clinical research industry, talking about the rise of this or that. And for sure, some of these things come to pass, but there are plenty of predictions that don’t age well – blockchain anyone? For once, let’s talk about things that are here to stay. What truth is so embedded in our lives that they will eat strategy for lunch, like technology proliferation? Or most importantly, what are the foundational principles that literally define the two words that make up the nomenclature of our industry? The words “Clinical” and “Research” reflect the simple and profound concept of performing science on human beings. Here is my short list of things that won’t change in 2024. By Joseph Kim, Chief Strategy Officer, ProofPilot

By Dan Braga, Vice President, Product Management, EHR and Healthcare Solutions, Medidata Repetition—depending on the task at hand—can be a positive or negative thing. On the positive side, repetition may assist in honing skills, enabling us to become proficient in what we do, whatever that may be. On the negative side, repeating specific tasks may be time-consuming, tedious, frustrating, or stressful. Data re-entry has been an issue in clinical trials for as long as many of us can remember. The question often asked is, why should busy professionals be forced to spend their limited time duplicating data that has been captured previously and is available from other sources, such as Electronic Health Records (EHRs), Clinical Trial Management Systems (CTMS), eSource, documents (e.g., lab values in a spreadsheet), or other systems? According to a survey conducted by Medidata and the Society for Clinical Research Sites in 2022, 98% of sites reported that they manually re-enter data into Electronic Data Capture (EDC) systems, with nearly 70% of them stating that more than 50% of their EDC data is re-entered using existing EHR data. This is inefficient, and it must be frustrating for research coordinators who could be spending time on more valuable study tasks or with their patients. In addition to the vast amount of time that this process takes, there is a high probability that transcription errors will be introduced, resulting in additional time and effort being spent by monitors and data managers on raising queries and by sites on resolving them—a laborious undertaking, given that the average number of queries per Phase III study was found to be 96,980 (Stokman, 2021). Also, remember that the data generated by clinical trials continues to increase yearly, adding to the growing burden. So, what has been done to resolve the issue, and why is it taking so long to find a solution? Isn’t technology meant to reduce or remove problems like this? Two Steps Forward and One Step Back Issues were recognized many years ago. EDC systems have long been used to collect, clean, transfer, and process clinical data. Efforts have been made by clinical researchers and technology providers to repurpose EHR data in a scalable way. Certain attempts to address the issues have shown great promise, and many positive steps have been taken to improve efficiency and reduce errors. Still, adoption and progress have been slow, with little change until recently. Additionally, automating EHR to EDC data transfer and integration benefits include reduced trial costs, earlier identification of safety events, and faster trial completion. With increasing complexity in clinical trials and the sheer volume of data being processed, automation reduces the burden of data entry and reduces data quality issues. On the other hand, in the background, progress has been slowed by issues that most users will not be aware of. For a start, the industry was initially working without universal standards, which we’ll come to in a moment. One limitation is the inability of specific EHR systems to interoperate (communicate and work together) with other EHRs. Another is the inability of data entry/transfer automation solutions to work with non-EHR data; some are limited to working with just a few selected EHRs. Variation in configuration from one EHR to another presents an additional issue. These challenges have led to longer implementation times due to complexity, higher resource requirements, and higher costs. This has meant that, while they have demonstrated promising results on single studies with a small number of sites, solutions have not proven to be easily scalable to multiple studies with large sites. Fortunately, a couple of crucial changes took place, paving the way for creating a new system that addresses the industry’s challenges and reduces the burden of data entry and re-entry for clinical trial professionals. The Turning Point On December 13, 2016, the 21st Century Cures Act was signed into law in the United States, with one of its aims being to enhance interoperability and reduce regulatory burdens associated with sharing healthcare data. This was a huge step, enabling specialist service and systems providers to create an interoperable ecosystem of solutions that help research sites and end-users. Additionally, EHR data interoperability was standardized by the Office of the National Coordinator for Health Information Technology (ONC) when they recommended using the HL7® FHIR® (Fast Healthcare Interoperability Resources) standard. Although extracting data from EHRs and feeding them into EDC systems remains complex, these changes have provided a tailwind and a standardized approach for data exchange. Furthermore, regulatory agencies have recognized the value of EHR data in clinical research and encouraged its use in guidance and recommendations. These changes enabled the creation of technology solutions that address industry challenges based on standards and interoperability. Is There a Solution Now? In 2022, a unique solution that exceeded the industry’s limited prior offerings and set a new standard was unveiled. The new system introduced interoperability beyond EHR and EDCs, expanding connectivity across multiple data sources while significantly improving the user experience. Using an alternative approach to other systems—one that doesn’t try to automate the process fully—provides easy-to-use tools that assist the Clinical Research Coordinator (CRC) in completing EDC forms (eCRFs – electronic case report forms) much more easily and quickly.  Because it doesn’t rely on costly, time-consuming, upfront mappings between EHR and EDC systems, which can change from study to study and system to system, set-up is quicker, easier, and scalable across multiple studies and sites. No automated solution has proven 100% accurate mapping between an EHR and an EDC’s specific clinical trial visit records. With the new system, the CRC always controls which data is submitted into the EDC system. The new solution takes a multi-pronged approach, leveraging multiple ways of getting data, and taps into existing networks and interfaces, including direct connections to sites’ EHR systems and data aggregation platforms. From a site user perspective, the solution is a data entry assistant that allows research coordinators to retain complete control over what is submitted into the EDC system. It supports structured and unstructured data, so it is simple to capture data from any source application or document. As it can operate with or without connection to an EHR system, it offers flexibility and adaptability to different workflows while leveraging multiple connectivity options whenever a link is necessary. With its more straightforward approach, the solution eliminates the need for an EHR to trial protocol mapping exercise, saving valuable time and effort for the research team. Most importantly, it removes the need for a highly tedious and time-consuming data re-entry process, replacing it ‘with just a few clicks’ for the user. Major US sites and site networks are rolling out this solution, and they’re seeing highly positive results, with site users finding it very easy to install and use; more importantly, they’re seeing significant time savings in completing EDC forms.  At one site, the time usually taken to complete an EDC form, requiring 48 lab values and seven other values to be entered manually (looking up the data in the EHR or other system/document and re-entering it into the EDC form), was 22 minutes. With the new data entry assistant solution, the same form, with the same data, can be completed in just 30 seconds. That’s 44 times faster, meaning that sites can complete data entry for more patients in less time, freeing them up for more valuable clinical research and patient care activities. An excellent white paper on this topic can be found here, and if you love podcasts, here is a link to the SCRS Talks Podcast with Jimmy Bechtel, MBA, VP Site Engagement, SCRS, and Dan Braga, Vice President, Product Management, EHR and Healthcare Solutions, Medidata. Summary By addressing interoperability challenges, enabling other source data to be captured quickly, and simplifying data entry, the new solution provides a user-friendly, simple solution for clinical researchers, eliminating the need to bounce between applications and making data entry and re-entry easier, faster, and more accurate. It means fewer queries, an easier workday, and more time to focus on critical tasks and patients. The result? Happy sites, CROs, Sponsors, and patients.  And all this is achieved “with just a few clicks.”

The 2023 Global Site Solutions Summit was one to remember, hailing our biggest turnout yet. More than 1,300 industry leaders joined us to share resources, knowledge and best practices while collaborating to improve the ever-changing world of clinical research. With more than 180 speakers across 12 plenary sessions, 40 breakouts and 8 therapeutic roundtables, many insights were shared on topics such as finances, inclusion, recruitment, staffing, business development and more. Site Landscape A new iteration of the annual Site Landscape presentation kicked off the Summit. Throughout the year, we’ve collected responses in micro-landscape surveys covering diversity, technology, and the site workforce. At this year’s Global Summit, we highlighted the most critical points industry stakeholders need to know. Record Retention New for 2023, experiences with record retention and storage were requested. What we’ve learned is that the nuances of voluntary record retention beyond a site’s regulatory retention period are becoming increasingly complicated. While some sites feel willing and capable of being long-term record storage vendors for the sponsor’s business needs, most don’t. Sites shared that they don’t want to be pushed into learning this new business. From these sentiments, it’s clear that sponsor support for alternate accommodations is needed. The most sensible option is for sponsors to use their own record storage vendors and remove the burden from the site. Accounts Receivable The site industry’s accounts receivable days are out of the norm for healthcare and a cause for concern. Although some sites may be partially responsible due to late delivery of deliverables, it is also heavily caused by poor payment terms in CTAs (i.e., quarterly payments and holdbacks). Even with 100% monthly payment terms, sites often see the sponsors/CROs not adhering to that schedule. There are things that are outside of our control, whether we work at a site, sponsor, or CRO, but it’s important to proactively communicate regularly and set the right expectations. Payment Terms The industry is making progress on getting back to monthly payments without holdbacks again. However, it is unfortunate that some sponsors are still initiating sub-optimal payment terms and switching to monthly payments without holdbacks only for the sites that ask for them. Having the cash flow necessary for optimal study conduct should not be subject only to good negotiating on behalf of the sites – it should be a standard issue in budgets. Study delays and cancellations are much higher now than they have been previously. To account for this, we are hearing budgets and contracts allocate study delay fees or cancellation fees to keep the sites afloat during that time. Having a contingency or “catch-all” budget is also gaining more traction to cover unexpected expenses that arise for a study. If you are involved in budgets at the site level and have not seen the SCRS Invoiceables Toolkit, this tool is available to help you calculate and negotiate budgets that better cover all your site’s costs. Workforce Workforce issues are still challenging sites, and several factors are at play. The most pressing challenge is the sites’ inability to compete with hyper-rising salary demands. Workforce development programs are needed for the industry as a whole, and some organizations have already begun offering scholarship and internship programs. Additionally, due to not having enough staff members, sites are having to be more selective in the studies they undertake and the sponsors/CROs they work with. Sponsors and CROs can also help sites understand upcoming trial pipelines so they can plan better for staffing needs. Technology & Training As we’ve become much more familiar and comfortable with DCTs, trials with decentralized components are now the norm. Now, we’re exploring the potential of AI. Many sites and industry partners have seen how AI can be a powerful tool for streamlining and enhancing our operations. Its potential to transform or automate processes, such as streamlining recruitment or feasibility questionnaires, is truly transforming the way we conduct research. As the use of technology in trials grows, so do training requirements. Unanimously, SCRS calls for industry partners to eliminate anything that is unnecessary, redundant or “check the box” training and shift to a more risk-based approach.  Provide options. Not every site or protocol is one-size-fits-all. Patient Perspectives As always, SCRS aims to help you reinvigorate your “why” by featuring incredible patient stories. Zahara Weeks shared her moving journey as a patient and trial participant with sickle cell anemia. Zahara and her mom, Kesha, walked us through their journey of finding a clinical trial and how they are working to expand trial opportunities for individuals with sickle cell. At only 14 years old, Zahara, with the help of her parents, has organized several donation drives for children with various chronic diseases and disorders, called “Marley’s Mission to Give.” In spite of the many ups and downs that life with sickle cell brings, Zahara is determined to live her best life and believes that faith and the support of her family and medical team will allow her to accomplish anything she dreams. You can learn more about Zahara’s story in her book, Born A Warrior. SCRS is also proud to partner with Oliver Patch Project (OPP) to empower pediatric treatment participants to find their inner warriors as they endure life-changing milestone events. Brian Burkhart, who also spoke at the 2023 Global Oncology Summit, shared more about his organization’s mission to create a free, engaging platform where children with childhood cancers and their families can connect through a series of unique patches. At the Summit, Brian distributed an Ignite the Possibilities patch for Global attendees to join the mission. Learn more about Oliver Patch Project and consider making a donation. Engaging Underrepresented Populations Diversity, equity, and inclusion was also a critical topic. Speakers shed light on comprehensive approaches to developing diversity plans, offering valuable insights into sponsor expectations for sites. We heard firsthand how sponsors prioritize and implement diversity plans and the pivotal role that sites can play in driving these initiatives forward. Ensuring diverse representation in trials is a priority for all, and sites are willing to help sponsors meet their emerging DEI goals, but not at the sacrifice of their core business. Many sites have made significant investments in diversity planning at their own expense, but not all sites are able to do this. To be successful with ongoing community engagement efforts, sites need non-study-specific resources and funding. Sponsors and CROs have reiterated that they are willing and able to help sites with DEI-focused initiatives, but that support is first dependent on the site understanding their needs and appropriately asking for them. Sponsors and CROs can also empower staff that negotiate contracts and budgets to say “yes” without the need for multiple levels of escalation, and to do so more quickly. Developing diversity action plans can be extremely useful in providing justification for community engagement-related funds. Celebrating Industry Innovation & Collaboration Honoring the achievements of sites and industry partners truly strengthens our work. At the annual Eagle Award Gala & Awards Dinner, sponsored by Advarra, we recognized several organizations that have made significant impact and progress on clinical research partnerships and trial modernization: Eagle Award: Merck as the sponsor recipient, and Parexel as the CRO recipient Site Patient Recruitment Innovation Award (SPRIA): Cedar Health Research Site Tank: AlzWell Christine K. Pierre Site Impact Award: Fabian Sandoval, MD, CEO of Emerson Clinical Research Institute Excellence in Patient Centricity Award: Velocity Clinical Research Global Site Excellence in Diversity Award: Ascension St. John Clinical Research Institute Summit Standout Awards: Best Exhibit Design: Digital Auxilius; Warmest Smiles: Transformative Pharmaceutical Solutions (TPS); Best Aim: Helios Clinical Research; Summit Spirit Award: Lauren Stockwell from Clinical Research Fastrack Never Stop Learning At the Summit, there are endless opportunities to hear different perspectives, understand new technology options, and share proven strategies to streamline operations. Now is the time to take lessons learned from the Summit back to your organizations. Share with your team and brainstorm how you can take action. If it feels like too much, focus on addressing one thing at a time. Let’s build bridges to better collaborate and #IgniteThePossibilities in clinical research.

Effective clinical research relies on strong partnerships between sponsors, CROs, and sites to ensure the success of trials. A recent panel discussion at Sites NOW shared valuable insights into how sites and industry partners can enable more transparency and better communication throughout every stage of the relationship. Open Communication & Feedback Building and maintaining strong relationships with research sites are crucial for successful partnerships. We have many tools for communication at our disposal, but open channels for feedback between sites and their industry partners are still underutilized. Establishing mechanisms to collect site insights and feedback should be a top priority for both sponsors and CROs. First, explore opportunities to streamline communication between clinical research associates (CRAs), site relationship managers, and finance departments to quickly address site issues and challenges as they arise. Regular retrospectives at the end of studies can also offer valuable insights for future decisions and site needs. Initiatives such as annual site satisfaction surveys and pragmatic budgeting can actively address site needs and bolster trust. In order to have effective collaboration between all parties, we must work to bridge communication gaps between sponsors, CROs and sites to develop a holistic and site-centric approach. Rethinking Feasibility Kylie Scheideler with CCT Research started the discussion stating, “We have unintentionally created this environment at the feasibility stage that is not conducive to sites. Feasibility has become a game. It’s very transactional.” How can we change this? First, feasibility questionnaires should be much more flexible. Sites are adaptable and can tailor their capabilities to various scenarios if provided with the right support, budget, and resources. Feasibility processes should allow sites to outline different scenarios and their potential impact on enrollment and study success, promoting realistic enrollment goals based on available resources. Sites can work to change the narrative by presenting their unique value and capabilities. With feasibility, it’s vital to strike a balance between ambition and realism. New sites in particular should avoid making overly ambitious promises during the feasibility stage. In many instances, new sites overestimate their enrollment potential, creating a gap between expectations and reality. While enthusiasm is commendable, it’s more important to set realistic enrollment goals and be aware of the challenges in recruiting patients. Rather than solely focusing on enrollment goals, sites should emphasize the quality of the data they can collect and their relationships with patients. While sites may have access to a pool of potential study participants, consider that patient engagement necessitates an appropriate budget to do so. Access to patients is just one part of the equation; the site’s staff must run reports, contact potential participants, and provide support to engage them effectively. Patient willingness to participate in a study can vary, and a site’s experience in engaging with patients can be a valuable asset. Leveraging Data Scheideler added that sites can strengthen their position during negotiations and demonstrate their value by leveraging KPIs and performance data. Key Performance Indicators (KPIs) are valuable tools for justifying budget requests and advocating for site needs. By highlighting enrollment rates, patient retention, and study completion, sites can demonstrate their competence and effectiveness to sponsors and CROs. If sites don’t have data, focus on establishing clear KPIs from the start. These KPIs can include metrics related to patient recruitment, retention, and adherence to study protocols. New sites can demonstrate their commitment to success by setting and tracking performance metrics from the outset. Scheideler also emphasized the importance of being proactive in building credibility. New sites should not shy away from highlighting their patient access and the quality of their patient relationships. While their enrollment goals may be more conservative, their ability to engage and collect high-quality data from patients can be a compelling selling point. Casey Orvin from CenExel added, “Know the value of your site and your assets and use them. Use metrics. Use your experience. Use what you’ve successfully done in the past. Educate and inform and use that to your advantage.” Hidden Costs Approximately 32% of research sites reported declining more than 10% of study contracts due to budget constraints. Furthermore, 12% of surveyed sites declined 20% or more of their agreements for the same reason. These statistics underscore a growing confidence among research sites in negotiating agreements, driven by a better understanding of their operational costs and the importance of sustainable financial arrangements. Sponsors and CROs are encouraged to be receptive to site requests, acknowledging that they are grounded in genuine expenses related to executing the study effectively. However, some sites have expressed fear of retaliation if they decline a study (i.e., the sponsor or CRO may not ask them to participate in another study if the site declines one). Sponsors and CROs are urged to keep in mind that honesty and transparency should be encouraged – never punished. As the industry increasingly embraces technology-driven approaches, ensure research sites are equipped with the necessary information to understand the true costs of conducting a trial. To make appropriate decisions, sites need more information early on, especially if a study needs to utilize new platforms or implement diversity, equity, and inclusion plans. Improving Technology Implementation Usability testing is essential to ensure technology is user-friendly and meets end-user needs. Sponsors should actively seek feedback from research sites about their experiences with various technologies to make informed decisions about vendors. By integrating site feedback, technology solutions can better meet the needs of research sites and their trial participants. Research sites, in turn, should ask about the purpose and value of the technology and tools they are asked to use. Lesley Freese from IQVIA Technologies suggested that sites consider questions such as: What purpose is this technology solving? What value is it bringing my site? And, what expectations do we have around this technology? Maintaining an open feedback loop with technology end-users (patients and sites) through interviews, surveys, and user panels is critical to enhancing the user experience. Enable sites to feel comfortable sharing their technology experiences, either through CRO or sponsor contacts or directly with technology providers. Additionally, solution providers can consider serving as intermediaries between the technology and end users, providing support, hearing suggestions, and reducing the site’s burden with technology-related issues. Fostering Site Partnerships: A Sponsor’s Perspective Some organizations have already established dedicated teams to communicate regularly with sites, preventing issues from escalating and enabling smoother study operations. Alisa Constance with Merck, the recipient of the SCRS Eagle Award for two years in a row, shared insights into how their organization is taking proactive steps to build and strengthen site relationships. One of Merck’s key initiatives is an annual site satisfaction survey, which allows sites to provide direct feedback. This feedback is analyzed and used to drive actionable changes in Merck’s clinical research processes.  Additionally, Merck places a strong emphasis on budget transparency, collaborating with sites to design comprehensive budgets that include recruitment funds. Engage with Sites Early For many sponsors and CROs, understanding the day-to-day operational needs of research sites can be a challenge. Early engagement with research sites, starting even before protocol development, has become essential. Collaborating with sites and principal investigators (PIs) during the early stages of study planning can significantly enhance the quality of study protocols and bid defenses. Sites possess valuable insights and resources that can be leveraged throughout the research process. It is crucial for sites to articulate their needs, and sponsors/CROs should either accommodate these needs or provide clear explanations for any deviations. Establishing a strategy for maintaining the ongoing relationship with sponsors and CROs, beginning with the Clinical Trial Agreement (CTA), will help partnerships thrive. Sponsors and CROs are also encouraged to continue advocating for improvements in site payment terms and withholding percentages to further enhance site-centricity. It’s clear that the clinical research industry has come a long way in ensuring the site voice is heard while working to establish long-term partnerships. As sites grapple with deploying new technology, workforce challenges, and managing rising costs, a new frontier of collaboration is coming to light. Embracing open communication, early engagement with sites, and transparent budgets are just some of the ways the industry can continue to work together to ensure successful, site-centric clinical trials.

SCRS comments on the Federal Drug Administration (FDA) 2023 Draft Guidance: “Decentralized Clinical Trials for Drugs, Biological Products, and Devices Guidance for Industry, Investigators, and Other Stakeholders” First, we applaud the FDA for preparing this guidance and its intent to foster the extension of the traditional research site via various mechanisms. It’s vital that the industry enables patients to have increased access to the necessary items and services required to successfully enter and complete clinical trials. We concur that there are proper ways to extend a clinical trial site/investigators’ traditional “brick and mortar” model to one that can be extended by technology, mobile research staff and healthcare providers that are more proximal to the patient at their time of need. Although it challenges the traditional business model of the site industry, the SCRS Site Landscape Survey results indicated that sites are participating in these kinds of studies in a post-COVID environment, the top two reasons being “would be beneficial to the participant” and “desire to bring my site into the future”. While we see the investigator/site industry as concurring with the purpose of this draft guidance and with many of the FDA’s recommendations herein, certain components of the current draft are having the opposite of the intended effect. Some components codify several systems and gaps that are known to contribute to investigators/sites’ unwillingness to facilitate decentralized components due to fear of regulatory retribution. Herein we take the approach of highlighting key issues we believe the FDA should address in this guidance to accomplish our shared goal. We cannot emphasize enough that the erosion of site/investigator oversight and the expected regulatory consequences have a negative effect on the adoption of decentralized/hybrid trials. Based on the 2023 SCRS Site Landscape Survey, overwhelmingly the sites’ answer to the question “what have you experienced to be the biggest challenges for your site in participating in decentralized trials” was “oversight of remote vendors that would interact with the patient, record source data”. For sites that refused to conduct trials with the added decentralized components, the second and third most common reasons cited were “not comfortable with this type of trial” and “lack of understanding on how the trial would operationalize”. The great majority of our comments relate to this theme of the site/investigator’s eroding control over the operation of the clinical trial, coupled with the reiteration that they remain ultimately responsible from a regulatory perspective. Thank you to our project contributors: Lisa Bjornestad, DM Clinical Research Daniel Fox, Clinical Research Payment Network Christie Fry, AbbVie Nadege Gunn, Impact Research Institute Kathleen McNaughton, Mayo Clinic Lindsey Morales, Gilead Sciences Debra Rogge, AstraZeneca Shivani Shah, DM Clinical Research David Vulcano, HCA Healthcare & SCRS Scott Whitt, Triad Clinical Trials Jennine Zumbuhl, Dignity Health

Modern medicine owes a lot to clinical trial participants. Patients give their time, energy, and often literal blood and other specimens to help find cures for today’s diseases and help speed drug development. Yet, offering a “thank you” to patients is an inconsistent practice at best. Thirty-three percent of clinical trial participants report low satisfaction with their clinical trial journey, according to a 2022 survey conducted by TransCelerate BioPharma and the Center for Information and Study on Clinical Research Participation (CISCRP). In a climate where finding and enrolling patients as well as retaining them throughout a trial are common barriers to a successful trial, the simple act of showing gratitude to patients can make a positive difference. Sponsors should design patient-friendly trials and equip sites with the tools to interact with patients in a meaningful way. To help address this, TransCelerate BioPharma recently released a Gratitude Toolkit to help stakeholders show appreciation to clinical trial participants and their care partners in ways that resonate. Potential Benefits The benefits of implementing gratitude into a clinical trial are multi-fold. It can: Improve recruitment (via word of mouth) and retention Improve a participant’s confidence in their clinical trial experience Improve relationships between site staff and the participants Demonstrate recognition of the challenges participants may be facing and may help support them in their clinical trial Improve the reputation of clinical research Improve a participant’s satisfaction and perceived value in their clinical trial journey Improve engagement, adherence, and compliance Help create a sense of community and a culture of gratitude How Sites Can Have an “Attitude of Gratitude” At the regional and site level, there are a few ways to demonstrate gratitude. For example, consider the cultural implications and appropriateness of different tactics and/or tools planned for the trial. Similarly, understand how local regulations and privacy laws may impact the implementation and roll-out of planned gratitude activities. Sponsors can consider how the planned tactics and tools will impact the sites. Is storage required? What does logistics entail and was training provided? At the study level, be mindful of the patient population and consider what is meaningful or what would help them feel appreciated. This can be done through insights research or obtaining patient feedback. Personalize the experience for the participants and their care partners. Post-trial, evaluate the benefit and impact of the gratitude program to make any necessary changes to ensure value. Some materials that can be in a site’s gratitude toolkit include: Thank You Cards or Letters A greeting card can be mailed from the study team to thank the participant for their participation, no matter the level. A card template with customizable text provides a personal way to show appreciation and gives the study teams the ability to adjust language in the thank you cards for increased personalization. These activities should not be applied solely to the participants that are currently in a trial. For some studies, 30 to 70 percent of participants of clinical trial volunteers may “screen fail.” While they may not be a fit for that particular trial, sending them a thank you card at this point in time could greatly impact their interest in future research. Inside the card, consider providing them with the rationale as to why the study is not appropriate for them; encouragement to look into other trials in the future; information on how to find other trials; an opt-in for those participants who do not enroll to be contacted for future studies. These “Do Not Enroll” versions of the card can be printed in bulk to make it easier for sites to mail to patients and their caregivers. Milestone Certificate A milestone certificate can be given to study participants at relevant study milestones to remind them of their progress in the study. They can be given at the beginning, middle, and end or sites can adjust the cadence in relation to the length of the study. Consider the distribution of these certificates as an opportunity for a personal discussion with the participant and their care provider on progress. While some may view a milestone certificate as “cheesy,” it prompts the site to take a moment to acknowledge the participant. The sites can have the flexibility to determine if it will resonate with a patient or not. Note that when using a milestone certificate, it is important to be mindful of the indication. For indications where there are limited other treatment options or participants have likely exhausted all available treatment options, study milestones may not be viewed as celebratory. Condolence Cards When a patient dies while participating in a clinical trial, it is distressing and painful for the patient’s family as well as the site staff that has cared for the patient. Expressing condolence to a trial participant’s family is a gesture that may not be usually done on the part of the site staff due to possible uncertainty about what is to be communicated. A personal, handwritten card can provide solace to a family in a difficult time. Express sympathy, use the patient’s name, and share that the patient made a difference by participating in the trial and that the study team is grateful. If a care partner was involved in trial visits or helping the patient while they attended trial visits, acknowledge their time. Additionally, the trial outcome may be particularly important to some families. Consider an insert which includes the trial name and number. Offer the family an estimated date of when they can expect these results (approximately 1 year after the trial’s last patient last visit (LPLV) is completed for adult trials; about 6 months after LPLV for pediatric trials). Flexibility A patient-centric trial should accommodate for the individual and cultural preferences of patients. The best way to determine what tools and tactics are most relevant to a specific country/region and ensure inclusivity is by testing them with the target patient population prior to study start. Some tactics and tools may require adjustment in terms of timing, content, or may not even apply. For example, in some countries, “thank you letters” from a site are not seen as appropriate. In those countries, a “thank you card” may make more sense from a cultural perspective. While TransCelerate’s toolkit includes materials for the entire process, sites need the flexibility to choose what works from them. Each trial is not a linear journey and the activities and emotions felt along the journey may differ from participant to participant. Ultimately, the relationship and the sincere appreciation that participants want to see and feel is between the site staff and the participant. TransCelerate’s Gratitude Toolkit is a toolkit that sponsors (in partnership with sites) can leverage to acknowledge and show appreciation to clinical trial participants and their care partners. Often, the sponsor will create the materials and provide them to the site for use with the patient. When using the Gratitude Toolkit, TransCelerate recommends sponsors consider flexibility and collaboration with sites to allow sites to do what is best for their participants. When in doubt, consider the impact of a simple verbal thank you. Today’s medicine would not be possible without clinical trial participants. By Proof Clinical & TransCelerate

There is a lot of discussion about diversity in clinical trials. The “why” is clear – more representation is needed to assess the effects of treatment on different people, across race, sex, age and so on, including intersections therein. Diversity is required to benefit the science and progress our understanding of various drugs and treatments – determining how treatments work for biological males vs females, for example, or whether medicines tested in adults can be safely used for children. And of course, to enable clinical research as a care option for all. It’s the latter that I believe will move the needle to gain more patient participation. It is also a factor that requires a broader diversity lens that includes equity and inclusion. The crux of the complexity here is the “how” – how to go about increasing diverse representation. One could argue it starts early with study design and factoring in biological differences that could unintentionally result in excluding a diverse patient pool. Diversity is a Journey, not a Destination Forums like the recent SCRS Diversity Summit bring together sites, sponsors, CROs, and advocates to have meaningful conversations about moving the industry forward. When it comes to diversity, equity and inclusion (DEI), patient recruitment is an ongoing engagement and not a final destination. Education and awareness are ways to engage with local communities and build trust. Overcoming distrust doesn’t happen easily – and maybe not even within a generation in some populations. It’s a long-term commitment, which takes money, time, and effort. It’s no surprise, then, that during the SCRS conference sites consistently talked about the need for allocated DEI budgets and marketing support. This is requested on top of the usual trial marketing budget. DEI initiatives are primarily relationship-building activities. There is a worry that without sustained involvement in underserved communities, DEI efforts will be perceived as purely transactional to hit a recruitment target for a given trial. This is where research as a care option must foster a mutually beneficial partnership between patients and clinical studies – one that satisfies the need for research data while at the same time providing high-quality care for the participants. Lobbying for Greater Inclusion There are recognized systemic challenges facing equity and inclusion. To this point, SCRS champions action. During the conference, the team prepared a letter for people to send to their US congressional representatives to advocate changes that will allow more people to participate in clinical trials. In particular, the letter advocates for changes that support participation opportunities for low-income, elderly and disabled patient populations. The letter opens with: “Acknowledging health as a human right recognizes a legal obligation to ensure access to timely, acceptable, and affordable health care. Yet we continue to perpetuate health disparities through existing legislation that works for some but not all – especially as it relates to clinical trial access and diversity.” The letter highlights several actionable items to remove unnecessary friction for patients entering a clinical trial, such as: Making patient reimbursements non-taxable income Eliminating unfair hurdles that burden the enrollment of the Medicaid population Revising travel reimbursement to make it more equitable Allowing clinical trial sponsors to pay for Medicare beneficiaries’ co-pays and deductibles for routine care items and services required by qualifying clinical trials Simplifying the complex and inconsistent rules for the Centers for Medicare & Medicaid Services (CMS)  Legislation to Expand Research and Access to Treatment The letter requests to have the points above included in the Cures 2.0 Act, which expands on the 21st Century Cures Act from 2016. Building on the previous legislation, the Cures 2.0 Act now aims to fund research to cure challenging diseases like cancer and Alzheimer’s, as well as improve how new treatments are delivered to patients, with approaches such as: Increasing diversity in clinical trials with reporting requirements of trial demographics and recruitment campaigns targeted at underserved populations Requiring the FDA to improve the collection and use of real-world evidence Expanding access to new healthcare technologies to Medicare beneficiaries Making telehealth services more accessible for Medicare, Medicaid and Children’s Health Insurance Program beneficiaries Send the Letter to Your Congressional Representation More than 150 people signed the letter during the SCRS Diversity and Oncology Summits in Austin, including myself. You can find instructions on how to submit a letter to your US congressional representative on the SCRS resource page. By Kelly Brown, Chief Marketing Officer, Teckro

Clinical research is constantly evolving and advancing, and leveraging eClinical technologies such as electronic informed consent (eConsent), electronic Clinical Outcome Assessments (eCOA), medication adherence, televisits, geofencing, and remote monitoring is playing an increasingly important role in the field. These technologies offer a range of benefits for both research sites and patients. Still, it can be difficult for sites to navigate the many options available and advocate for “site-friendly” providers. This ebook will explore the benefits of these technologies and provide guidance on how sites can successfully leverage them while also being adaptable to the changing landscape of clinical research. In this ebook, we will explore: The benefits of eClinical technologies Advocating for “site-friendly” providers The Impact of Decentralized Trials on Sites Leveraging eClinical Technology for Success Download this eBook to learn how to leverage technology to your advantage. Through advocacy, training, and support, sites can benefit greatly from tools and technology designed to ease site and patient burdens. Discover how to best partner with vendors and advocate for site-friendly technology. Contact us to learn more about our solutions and services and how to implement these technologies seamlessly into your day-to-day operations.

In a world being increasingly driven by data, it is surprising to hear in casual conversations with other research professionals that most enrollment feasibility analyses are overly optimistic “best guesses”, relying heavily on busy coordinators’ and principal investigators’ knowledge of their patient population. Not to discredit any investigator or staff member, but getting a gut-feel answer that is an accurate enrollment estimate seems difficult, to say the least. Additionally, some sponsors and CROs often give as little as 24 to 48 hours for sites to respond to quite detailed feasibility questionnaires, adding more pressure to respond quickly without critically evaluating the protocol and accessible patient population. While patient recruitment technologies are gaining popularity in assisting sites with finding research candidates, there remains a lack of data-driven methodologies used by research sites to accurately estimate enrollment counts prior to ever taking on a study. For healthy population studies, there is less risk of underperforming, as I/E criteria are typically very basic for these studies. However, most trial protocols consist of extremely complex I/E criteria, often including time-based requirements, surgically confirmed conditions, and other rigorous parameters. We might as well throw a dart at a board of numbers and report it as fact, as one site employee stated in conversation when describing the act of predicting enrollment during feasibility analysis. A case study published in last year’s SCRS July Newsletter1 illustrated the ability of an innovative technology solution to reduce a simple patient search yielding 45,000 potential study candidates down to 1,874 high-quality, prequalified candidates after considering complex protocol I/E criteria limitations. What if this site’s feasibility submission had been based on the initial search criteria, yielding 45,000 potential candidates only to come up with 1,874 viable candidates once enrollment initiated? Not only would the site have spent countless hours filtering through patients to find ones that actually met the detailed I/E criteria of the study, but the site could also have: failed to reach their enrollment targets, incurred a large financial burden by accepting a study they could not properly enroll, and damaged their relationship with the study sponsor, impacting future business opportunities.  Not only is protocol I/E criteria becoming more difficult for potential candidates to meet, but new laws and regulations2 also continue to be released from Congress and the FDA requiring enhanced diversity and inclusion in trials3.  Without data-driven feasibility technologies being used to set research sites up for success, these commonly encountered obstacles will only be magnified as research complexity increases. This same congressional release from December 23rd, 2022 discusses “using digital health technologies to help improve recruitment and participation in clinical trials”; although, it fails to mention the need for data-driven methods to assist with answering feasibility questionnaires.2 The issue of poor enrollment performance is not a one-sided problem. Finding qualified candidates more efficiently is indeed a large part of the solution, but we also need to approach the problem by looking upstream. Research sites must be able to set themselves up for successful trial execution by accurately estimating their enrollment potential and no longer using best guesses to complete feasibility questionnaires. It is also worth noting that some sites already using innovative technologies for enrollment predictions have admitted to being penalized by sponsors for providing lower counts, despite them being more accurate than their peers’ estimates. Therefore, it is imperative that sponsors start working with sites using these technologies to set realistic enrollment targets that can actually be met.  When all parties involved have the same goal of enrolling patients to accelerate medical innovation, it is important that they all have the same approach to solving the problem. The use of technology solutions leveraging patient medical history to perform feasibility analyses will allow: Sites to have confidence in their ability to succeed in the studies they choose to pursue. Sponsors to get an early indication of their need to pursue a protocol amendment, re-calculate the number of sites needed to hit their enrollment targets, and reassess their enrollment targets altogether. Studies to be executed closer to the sponsors’ planned costs and timeline. Shifting the way an entire industry thinks about how feasibility should be performed will take some time, but the early adopters of this new data-driven feasibility standard will undoubtedly experience improved study performance. By Aspen Insights Aspen Insights. Society for Clinical Research Sites. July 12, 2022. Accessed May 26, 2023. https://myscrs.org/resources/supercharging-the-chart-review-process-with-ai-technology/. H.R.2617 – Consolidated Appropriations Act, 2023. Congress.gov. December 22, 2022. Accessed May 26, 2023. https://www.congress.gov/bill/117th-congress/house-bill/2617. NIH-wide strategic plan for diversity, equity, inclusion, and accessibility (deia). National Institutes of Health. March 20, 2023. Accessed May 26, 2023. https://www.nih.gov/about-nih/nih-wide-strategic-plan-diversity-equity-inclusion-accessibility-deia.

Technology today can provide benefits and opportunities for clinical trial participants and sites alike, improving efficiency, accuracy, and engagement.  Experts across the industry agree that for solutions to be effective and adopted, they need to address specific problems, as well as meet and exceed the expectations of users. For example, participants today expect flexibility, including the option to use their phones or other digital devices to complete trial activities, track symptoms, schedule on-site visits, and receive payment for their participation. Sites reinforce the value mobility can provide; according to the newly released Greenphire Patient Convenience Market Trends Survey, 86% of sites said it is important to provide clinical trial participants with the ability to access their study information digitally. However, the ability to provide this value add cannot come at the expense of site staff.   In this article, we explore this topic further, answering key questions regarding how we can enable patient engagement with a critical eye on supporting sites.   What makes mobile technology effective for site staff? It is a fair question given the nuance and many hands involved in successfully ushering a clinical research from recruitment to close-out. There are many technologies that clinical sites use over the course of the study, either provided by sponsor, CRO, or purchased. We believe that technology has the power to streamline trial workflows from beginning to end, with the ultimate objective of evaluating drug efficacy and safety so treatments are put in the hands of those who need them, faster.  In particular, mobile technology offers many of the same benefits that it has had to other industries and global markets: ease of use, convenience, and interaction – interaction arguably being the most important component.  Improving patient recruitment, retention, and overall experience is a top priority for clinical research sites as patient dropout is a significant and persistent challenge they face. Patient engagement solutions have emerged as a key way to retain participants, and the development of new mobile technologies such as Greenphire’s participant-facing application, GreenSpace, have the power to dramatically improve study results. Additionally, these solutions make quick work of historically tedious paper-based tasks which can be labor-intensive and potentially error prone for both site staff and participants alike.  Accessibility and Communication Technology and convenience are two items that people often associate together. Adding the purpose of increasing patient engagement by incorporating new technologies and services based around participant experience can create improved accessibility. Research has shown that 70% of potential clinical trial participants live two or more hours from the nearest trial site. Additionally, sites are under increased scrutiny to improve study diversity; the Center for Information & Study on Clinical Research Participation validated in their 2021 Perceptions and Insights Survey that underrepresented communities (respondents who identified as Black and/or Hispanic) were more likely to cite the availability of mobile apps as important compared to White respondents.  This further emphasizes the need for mobile technology to help improve retention of all trial participants. Additionally, mobile technology allows participants and site staff to easily touch base in between in-person visits. It also gives participants the ability to log health information, access educational materials about their treatment and submit any questions they have. This bi-directional flow simplifies communication – an area known of frustration for participants but also difficult for site staff to scale easily and effectively.  What About Security? While life sciences have been slower to adopt mobile technologies than other more retail industries, it has been with good reason. The convergence of health and personal identifiable information in clinical trials, puts data privacy and information security at the forefront. Mobile technology used by patients must be equipped with the necessary security measures and regulatory requirements, especially in regard to privacy (including GDPR), tax management, and banking. Integral processes and safeguards implemented through validation, security systems, data encryption, and authentication mechanisms can reassure patients of concerns regarding what information they may input or review within the tool, application, or technological solution. Site staff must have confidence not just in the application and their ability to instruct participants on its use, but also the inherent protection of the data which is available within it.  Are Sites Equipped with the Tools to Recruit and Retain Patients? In a recent survey conducted by Florence Healthcare, 80% of sites reported they do not meet their recruitment goals on time. Even with numerous companies offering patient recruitment services, it still remains an issue. Mobile technology has the ability to reach potential participants that aren’t typically targeted, and allows them to connect with others with the same diagnosis to learn about research studies being conducted. Patient dropout is a key problem faced by research sites (and the industry). Participants often cite the time, travel and out-of-pocket costs associated with clinical trial participation as core reasons for leaving prematurely, all the while, sites struggle with the administrative efforts of managing increasingly complex protocols.   Can Mobile Technology Help? Certainly. Data from veteran trial volunteers confirms the positive impact mobile technology has had on their experience – potentially leading to improvements in the effectiveness of the research program overall. CISCRP polled those who were enrolled in clinical research trials when the pandemic began, and 41% of them said that they were “very satisfied” with the use of smartphone apps. Additionally, when polled in our 2023 Greenphire Patient Convenience Market Trends Survey, 90% of clinical research sites thought it would be valuable for patients to have a singular access point to access study information such as reimbursements, transportation, appointment reminders and more.  However, clinical sites need our help. The 2022 SCRS Site Landscape Survey evidenced that sites (76%) need support from sponsors and CROs in developing stronger and more robust budgets to allow for increased participation in decentralized (or hybrid) trials. Focusing on removing financial and logistical barriers from patient participation can improve retention, and sites agreed with that sentiment (89% [62.7% believed strongly], Greenphire 2023 Patient Convenience Market Trends Survey). By investing more in mobile technology, it is possible to provide more opportunities and improve retention and recruitment of patients for clinical sites in addition to capitalizing on the innovative solutions being developed and provided to clinical sites globally. By Tanya Kogan, Senior Product Manager, Greenphire 

How Co-Creation with DCT Vendors, Sponsors, and Sites Makes Participation in Decentralized Clinical Trials Easier For Sites Full-service decentralized clinical trial vendors can offer sponsors virtual (remote-based), traditional (brick-and-mortar), and hybrid site participation in their clinical studies. This flexibility in supporting site participation can be pivotal in running a widely accessible and successful trial. Regardless of the type of site model a study utilizes, one idea remains. Co-creation between DCT vendors and sponsors with the incorporation of sites’ input is imperative to achieving an effective and sustainable trial design. Learn more about how co-creation works from Curebase.

I remember my first code as an Emergency nurse. EMS rolled the patient into the room, I watched as the entire team moved in what seemed like a choreographed dance. Everyone had a role. IVs, breathing tube, documentation, drips, suction, compressions. Everyone knew their place. As I tried to focus and will my body into the room to actually do something, I was handed a bag of the patient’s belongings and told to catalog the items. Even as a new nurse in downtown Baltimore, you learn quickly that you DO NOT blindly stick your hands in pockets. It wasn’t out of the realm of possibility to be stuck with a needle. On a table outside the room, I gently shook out the man’s pockets. Some loose change, a few dollar bills, a business card, lighter, tiny plastic bag with residue in it, and a thin wallet fell onto the table. Of all the belongings, I will never forget the wallet. There was nothing special about it. It didn’t have any fancy designs and wasn’t packed with cash. It was just a plain brown leather wallet with regular things in it: a license, a bank card, a check that needed to be deposited, and an appointment reminder card for an upcoming doctor visit. What struck me was how this wallet ended up in front of me. This man started his day like any other. He got up, got dressed, combed his hair, slipped his wallet into his back right pocket, and grabbed his keys as he walked out the door. It likely didn’t cross his mind that he would never walk back into his house again or that he would end up like this: on an Emergency Room stretcher, clothing cut off, ET tube hanging out of his throat, foam coming from his mouth, a glazed over look in his eyes, and, if he was one of the lucky ones, family in another room when they heard the news. I didn’t realize it at the time, but that thought would become a core memory in my nursing career. This same story would play out over and over in the next year as I worked code after code, and even though I was more actively involved in each one, I always took a moment to look at the patient’s belongings. Every time, it was the wallet of the male patients that struck me. After the Emergency Department, I moved to Trauma Critical Care. There, it was an unavoidable truth that many of the patients would die. Multiple broken bones, shattered pelvises, fractured skulls, traumatic brain injuries, shock, multisystem organ failure…the list goes on. At some point, you have to learn to protect yourself emotionally or you cannot effectively do your job. You will end up cataloging the belongings of the deceased outside a room every shift and then head straight to therapy after work and then home to your six cats. Emotional protection is also called “the wall” and it looks different for everyone. Of all the patients I’ve had the privilege of caring for in my nursing career, I’ve only gone to one funeral. She was a sweet lady who had been in the ICU for almost 3 months in 2014 after being hit by a drunk driver on her way home from work. She was doing so much better when she was finally discharged. She still had a trach and was hoping to have it removed after a few weeks of rehab. She wasn’t at the rehab facility for more than a week and her son called me to tell me she passed away. Her trach was clogged with mucus (“plugged”) and she suffocated. It’s been eight years since she passed, and her kids still text me every Christmas, on my birthday, and on the anniversary of her passing to say thank you. If you had asked me ten years ago in the height of my ICU days if I could ever picture myself doing clinical research in a nine-to-five office job with no nights, weekends, holidays, feces or vomit, I would have laughed. How boring! No one is trying to die on me all night long? No stress about whether my next patient will be the one to emotionally break me or if I can absorb any more stress and push it down deep into the abyss and show no weakness to become the biggest badass nurse ever? YEAH RIGHT. And yet, here I am. Still in bed at 13:15 on a random Friday afternoon, feeling completely lost, no motivation to do anything and intermittently sobbing, mourning the loss of a patient and a friend. At some point, you have to learn to protect yourself emotionally or you cannot effectively do your job. I met Jorge* in 2018 (name and some details changed for privacy). I was brand new to clinical research and he was one of my first patients. He was in one of our cardiovascular trials for a new PCSK9-inhibitor that was hitting the market. He was in his late 60s, about 5’6”, skinny, with salt-and-pepper hair, living only on his social security check, barely at the poverty line with minimal insurance, and cohabitating with his estranged wife because they could not afford to officially divorce. Of all the challenges life had thrown his way since retirement, he was remarkably friendly. He loved coming to the clinic. He liked to talk, and I always had plenty of time. I got to know him pretty well. I never met his kids, his dog, or his grandkids, but I felt like I knew them, too. And likewise, we talked about my kids and my husband, our new dog, the kitten we got for my daughter, and the old cat we had to put down. Every time he came in, it was like catching up with an old friend. I once told him he reminded me of George Costanza from Seinfeld. He laughed. He immediately knew what I was talking about. It’s my big wallet! he said. Every time he sat down, he had to take it out of his back pocket because it was packed to the gills with receipts and pictures of his grandkids and his dog, a fluffy white Bichon Frise named Vader, after his favorite Star Wars character. He would set the wallet on the desk, and then he would sit down in the chair next to me, and we would start our research clinic visit. I would get his vital signs, draw his fasting lab work, refill his study drug in a refrigerated cooler bag, and review his last visit’s blood work. We would discuss his current medications, any changes in medications or dosages since the last visit, and any barriers to compliance he may be having like the cost of his meds.  Once the required visit questions were done, we would chat about whatever he wanted. He talked a lot about his time growing up here. He was a “local”. Florida has been a red state for a long time, but he grew up in a family of progressives, which was not as acceptable to the general public in the 1960s. When he was 9, someone tossed a Molotov cocktail through his living room window and his house caught fire! Apparently, someone didn’t like the fact that his mom spoke up for a black family being harassed at the grocery store earlier that day. They fled the area and moved in with some family farther south for a few years. Jorge had plenty of excuses to be angry about the state of the world, but somehow, it never phased him. Jorge loved people. I often thought of him in a Mr. Rodgers light. He was excellent at finding the good in people. There was always a silver lining. It was so refreshing, and I looked forward to our chats. After the study ended, Jorge wanted to continue on the medication he was using in the clinical trial. The drug received FDA approval the year prior and, together with one of the local agencies that helped senior citizens at or below the poverty line obtain the medications they needed, we made the case for Jorge to be approved for the drug. Unfortunately, the insurance company didn’t see it that way and denied his request. Jorge had plenty of excuses to be angry about the state of the world, but somehow, it never phased him. In the months after the trial, I kept in close touch with Jorge. I would have him come in for a cholesterol check every so often. I had another trial he could join, but in order to qualify, his LDL-C had to be at least 70. Month after month, we waited. Finally, a reading of 71! We reviewed the informed consent months ago. He was ready. At the end of 2021, I randomized him into a double-blind, placebo-controlled trial for a new medication that worked very similarly to the previous medication he was on. He was so happy to be in another study with me and my team! Monthly visits meant more chats, more smiles, more laughs, and more learning from my friend from another generation. This had been a tough year for Jorge. His son died suddenly and unexpectedly earlier this year. He was in his early 30s and started abusing prescription medications after a botched back surgery. I don’t know many people that would want to share those details. Some might feel shame to admit their child was a drug addict. But not Jorge. He told me everything. His son was a successful engineer. He made something of himself, he said, and I was proud of him. His son fell off some scaffolding at a job site and injured his back. He had surgery a couple of weeks later and the pain was even worse than before. He ran out of pain medication and couldn’t get it refilled. He borrowed some from a friend here and there, and even a few from his dad when Jorge couldn’t stand to see him suffer (Jorge also had chronic back pain and took a low dose of hydrocodone twice a day to keep his pain below a five). Unbeknownst to Jorge, his son found relief in some heavier substances and was found dead in his home. Jorge was devastated. I was devastated for him. Hearing the quiver in his voice as he talked about his late son brought me to tears with him. Where had my emotional wall gone? A few months after that, Jorge’s best buddy Vader, the Bichon Frise that had been by his side for 17 years died in his arms. I am a dog person. I get it. Together, we cried in my exam room while he told me how much he would miss Vader’s stinky breath in his face every morning at 5:00 am. First his son, then his dog. I could not imagine how someone could weather both of those storms back-to-back, but somehow, Jorge carried on. I could not imagine how someone could weather both of those storms back-to-back, but somehow, Jorge carried on. At his last few clinic visits, he carried a satchel with him. He finally got new jeans and the back pockets weren’t stretched out enough to fit his overstuffed wallet. We chuckled as he poked fun at himself for carrying around a “man purse” or “murse”, another reference to his favorite show, Seinfeld. I last saw Jorge two weeks ago at his regularly scheduled appointment. He was in good spirits and happy to see me as usual. It was a busier than usual day in the clinic, but we still made time to chat. He told me his daughter and granddaughter had moved in with him and how he loved being able to spend so much more time with them. He was in charge of driving his granddaughter to school and he would wait for her at the bus stop every afternoon. We received a call at the clinic yesterday from Jorge’s estranged wife, Jane. She called to let us know that Jorge had suffered a massive heart attack earlier in the week and died. He was transported to the local emergency room, his overstuffed wallet and murse with him, where he was pronounced dead shortly after arriving. He had a breathing tube, his clothes were cut off, his chest bruised from CPR compressions, his eyes glazed over, and his family sobbing outside the room. I don’t know how long it took his nurse to catalog everything in that gigantic wallet, but I do know that my name is on that list because he had several of my appointment reminder cards jammed in there among the receipts and photos. I’ve cried in previous nursing positions, but those tears were from the shock of the situation, seeing things I never thought I’d see, and witnessing grieving families grapple with those first few minutes of processing such immense loss. I never spent enough time with a patient to miss them. Even my ICU patient whose funeral I attended, I wept for the family. For her son and her daughter with whom I had spent countless hours. I wept because I was sad for THEIR loss. Yes, I cared for her for three months, but she was only “awake” for the last couple of weeks and could never talk because of the ventilator. And, at that point in my nursing career, my emotional protection wall was SKY HIGH. Today, I am crying because I miss Jorge. I miss my patient. I miss my friend. I’m heartbroken. I’m so, so sad. I wish I could tell the ICU nurse I was ten years ago that clinical research is nursing. THIS is nursing, and as a nurse, it’s okay to get attached. It’s okay to make a connection. It’s okay to be invested. And, it’s okay to grieve for patients when they are gone. Rest easy, Jorge. I will never forget you. By Jillian M. Agnew, RN, CCRC, Senior Clinical Research Nurse, St. Johns Center for Clinical Research

Every industry relies on technology for progress, but in the life science ecosystem, it truly impacts the work we do. Of course, technology often also comes with challenges such as complexity, uncertainty, resistance, cost and skills gaps. How can we overcome these challenges and succeed in our digital transformation journey? This edition of Sites NOW explored all things digital innovation, including creative ideas and cures for tech congestion. Navigating the Implementation of New Technologies in Clinical Research Mohammad Millwala from DM Clinical Research firmly believes that sites should embrace a technology strategy. He emphasizes that by adopting technology, sites can chart their own destiny instead of relying on external sources. He sees technology as a solution for growth and business sustainability. As a people-centric business, technology should be there to support the efforts of the sites and ultimately, their patients. Millwalla added, “If sites don’t embrace technology, it will be imposed on them. By embracing technology, we can shape our own destiny instead of relying on a mix of technologies from elsewhere.” In the fast-paced world of clinical research, the adoption of new technologies is often a necessary step towards progress. However, the process of onboarding and integrating these systems can present challenges for research sites. Vivienne van de Walle from PT&R highlighted the multitude of vendors and platforms that research sites often encounter when starting a new trial. She likened the experience to being trapped in a challenging escape room, emphasizing the need to find solutions that work seamlessly for sites and the various trials they manage. A streamlined startup process is essential to accelerate research rather than impede it. The COVID-19 pandemic acted as a pressure cooker, necessitating the rapid implementation of various technologies overnight. In some cases, research sites were moving ahead faster than the sponsors, as critical decisions had to be made promptly for the benefit of patients. To navigate this accelerated pace, van de Walle adopted a proactive approach. One of the key steps she took was to undergo all the necessary trainings upfront. She requested sponsors to provide access to trainings and portals, enabling her to evaluate and assign the most suitable staff members for each platform or vendor. This approach ensured that the necessary expertise was available within her clinic and streamlined the onboarding process. Additionally, she invested time in understanding the time commitment required for training and implementation, considering the impact on clinic operations. Van de Walle also created a system to manage the multitude of vendors and platforms encountered during trial startup. To achieve this, she developed a comprehensive Excel sheet that listed all potential vendors and requested information from sponsors and CROs. This included the vendor’s URL, sponsor’s name, and estimated time required for training. Having access to this consolidated information enabled her team to identify specific vendors and platforms required for each trial. With multiple trials in progress simultaneously, this oversight proved invaluable in streamlining operations and ensuring the right technologies were utilized for each study. While acknowledging that the Excel sheet is not a standardized document due to the ever-evolving nature of the industry, it serves as a useful tool for adapting to new trials and incorporating additional vendors. Other sites participating in the discussion echoed that they also had a similar document for tracking vendors and portal logins. Open communication with solution providers is essential in understanding the cost implications and gauging the overall impact of system adoption. Van de Walle personally reaches out to vendors, especially those she has met at industry events. This direct contact allows for discussions about their technologies and the potential for adaptation. However, some vendors may direct such conversations to the sponsor, highlighting the need for flexibility and collaboration in this rapidly changing landscape. Lydia Beaudette from Centricity Research also reinforced the need for organized tracking of portals and associated training requirements. The integration of such tracking systems into sponsor-site platforms enables seamless communication and provides visibility into training requirements and estimated timeframes. If sponsors and CROs make this information proactively available, sites can include it in budget discussions and be fairly compensated for the work involved. On the Frontline of Customer Service All industry stakeholders share the common goal of supporting patients and ensuring the smooth progress of trials. To achieve this, Millwala advocated for the establishment of a more robust customer service team dedicated to assisting sites. This team would address various challenges, such as technical malfunctions and screen failures, which can impede trial progress. Dr. Margarita Nunez from Synexus Clinical Research reflected on the incredible transformation of trial processes facilitated by technology. Prior to 2019, technology was sporadically used for specific trial purposes as requested by sponsors. However, the pandemic necessitated a reevaluation of existing practices and compelled many sponsors to embrace technology more comprehensively. Dr. Nunez shares that her site had primarily relied on paper-based sourcing for a long time. The transition to efficient digital signing has been a welcome change, although the effectiveness depends on the chosen vendor, as sites are dependent on the sponsors’ decisions. Nevertheless, Dr. Nunez acknowledges that incorporating technology into the lives of older patients can be demanding. Patients may require extensive guidance and support to navigate digital tools and data collection methods. Ensuring patients’ proficiency in using study technology has become an integral part of the screening process, including the ability to maintain electronic diaries or download relevant applications. This additional time and effort invested in facilitating patient technology literacy often go uncompensated. While the integration of technology has greatly expedited and improved various aspects of research, it is crucial to recognize the need for adequate compensation for the time and resources invested in patient education and support. Balancing the benefits of technology with the unique requirements of patients across diverse demographics remains an ongoing pursuit in the pursuit of efficient and patient-centric clinical research. Customer service emerges as a fundamental aspect of the research process, ensuring that sites receive the necessary support to navigate technology-related challenges. Millwala underscored the need for a robust customer service contact or team to assist research sites effectively. He commented on the frustrations that arise when a diary malfunction or technical issue leads to a screening failure, jeopardizing the progress of the trial. Such situations often result from factors unrelated to the site or the protocol itself. However, with reliable customer service from the vendor, these challenges can be promptly addressed, mitigating potential setbacks and preventing the loss of valuable study participants. Anticipating Roadblocks An ideal solution for all is to involve sites during the planning stage of a trial. This collaborative approach empowers research sites, enhances their understanding of the technology, and aligns the system with their specific needs and workflows. By engaging sites early on, teams can proactively address potential errors and optimize the use of technological portals.  This also reiterates the importance of accurately assessing the performance of vendors’ products and ensuring they meet the necessary standards for both sites and patients. This collaboration between technology vendors and sites fosters a more comprehensive understanding of trial requirements and helps prevent issues that could compromise patient inclusion. Furthermore, Millwala advocates for comprehensive training for site staff on the various technology platforms employed in clinical research. Given the rapidly evolving landscape of study technology, continuous education is essential to ensure optimal utilization and compliance. However, he highlights the importance of appropriate reimbursement for training efforts. Aligning reimbursement with training requirements would not only encourage sites to participate actively but also acknowledge the investment of time and resources involved in enhancing staff proficiency. Payment for training should not be an afterthought but rather a part of the budgetary process. Developing the Next Generation of Trial Technology There are many opportunities to save time and reduce confusion for all parties by implementing simple changes. By keeping all parties informed, maintaining open communication, and developing systems that can integrate with one another, sites, CROs and sponsors can establish practices that optimize the integration of new technologies, ultimately enhancing the efficiency and success of their trials. One attendee also shared that they have suggested that sponsors consider the technologies adopted by sites themselves. It is noteworthy that sites are increasingly incorporating their own technologies, such as eSource, to streamline their operations. Sponsors could evaluate sites’ vendors and pre-approve them as trusted partners. It would be advantageous for sites to know that the sponsor has vetted and approved the use of specific technology solutions. Moreover, this process would enhance sponsors’ familiarity with the functionality of these technologies, potentially leading to integration with other selected components of the trial execution. Beaudette agreed, “I really do think, from a site perspective, there’s responsibility for us as well in embracing technologies that make sense and then advocating for how those can best connect.” Creating a culture of collaboration and customer service in clinical research technology is crucial for improving trial outcomes and streamlining operations. By prioritizing robust customer service support, involving research sites during trial planning, and providing adequate training opportunities, the industry can optimize the use of technology and promote a more efficient research environment. Open innovation is the practice of collaborating with partners, customers, and suppliers to source and share what is being done, what’s working, and what might work for the market in general. This concept allows all stakeholders to gain access to new ideas and capabilities that perhaps wouldn’t have been considered internally, while also helping reduce costs and accelerating time to market, ultimately increasing customer satisfaction. That’s what we aim for at every SCRS Summit. We welcome everyone to participate in an SCRS event and share their challenges and ideas so we can move clinical trial technology forward together. Through shared responsibility and mutual understanding, stakeholders can collectively work towards advancing clinical research and ultimately improving patient outcomes. It is in this spirit of collaboration that the potential of technology in clinical research can be fully realized.