Sites NOW

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.

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.

An Inside Look from Sites NOW: Diversity in Motion We all understand why the representation of diverse populations in trials is critical to ensuring health equity, accurate data, and patient safety. However, knowing the right ways to engage underrepresented communities remains a challenge for many sites and industry partners. Fortunately, we have seen great strides to break the mold to ensure patients from all backgrounds have informed and equitable access to clinical research. The January Sites NOW discussion explored stories and best practices from site leaders who are building trust in their communities and exceeding diverse enrollment goals in their trials. The panel members included representatives from various backgrounds with unique stories of how they have impacted the patients they work with. Plus, hear inspirational stories as well as actionable advice on how to build trust and access to diverse communities for your clinical trials. Let’s take a deep dive into how clinical research sites can successfully increase diversity, equity and inclusion in their trials. Strategies to Make Connections in the Community Ana Marquez, Chief Diversity Officer for Flourish Research, led her team to become a top global enroller for a study by focusing on building relationships with consulates and community clinics for underserved populations. Her team accomplished this by taking a different approach, like going into small markets and communities in order talk to the community directly. “Get creative and really think about where your target audience is,” she said. It’s not always easy to go out and talk to people we don’t know. That’s why it’s important to find the right person that is motivated and comfortable with talking to strangers. Marquez also mentioned it’s extremely helpful to hire people that look like the community you want to attract. Through Flourish’s community outreach, they met a patient with end stage pulmonary fibrosis. “He didn’t know about clinical research,” said Marquez. “If we would not have been out in the community making these connections, he would have not learned about his options.” He was quickly connected to a transplant hospital where he was able to get a new set of lungs, and has been doing well for nearly 7 years. Preparing for Inclusivity and Accessibility Eden Stein, Executive Director, Patient Insights & Engagement at Centricity Research, shared a story about a patient living in California that was diagnosed with primary membranous nephropathy. His doctors were discussing dialysis and next steps when he started researching online and found out about clinical trials. Stein said the patient was eligible for the trial out of their Arizona site, so they coordinated transportation across state lines. Fortunately, they already had a Spanish ICF and Spanish-speaking staff to increase accessibility for the Spanish speaking population. By taking practical steps ahead of time to make sure language barriers don’t stand in the way of enrolling patients in trials, sites running these studies can make a real difference in the lives of those who are affected by debilitating conditions. One common misconception is that you cannot consent a patient if the PI does not speak their language. However, Ana Marquez stated that any employee that speaks the language can consent a patient as long as it is documented adequately. “We really try to do whatever we can ahead of time to decrease barriers for patients that are not English speaking.” Stein also noted her employees speak 27 different languages across their 45 sites to help break down any language barriers. “Planning ahead to intentionally increase accessibility for these populations is incredibly important. The patient was able to join the study at our site, and was with us for six months while a site that was closer to his home got started. We were able to delay dialysis – a huge change of life for this patient.” Training a Diverse & Inclusive Workforce Dr. Fabian Sandoval, President & CEO of Emerson Clinical Research Institute (ECRI), said his organization has been focused on diversity since the very beginning. They’ve been successful in increasing diversity within their therapeutic areas, while also expanding their reach through TV shows and social media initiatives. Currently, they reach over half a million people every Saturday with plans to expand their TV show across the country. However, it wasn’t always easy. Dr. Sandoval mentioned it was an uphill struggle to gain traction with their TV show and social media for the first two years. Now, they have established rapport with their communities and are focused on building a diverse workforce. Recently, ECRI developed an in-person and virtual internship program in partnership with a local university. The program teaches students the value of becoming a study coordinator and principal investigator while learning the history of clinical research as well as practical understandings of EDCs, patient consent, community outreach, and the FDA. Once complete, the students can apply for a longer internship or job. Dr. Sandoval is even helping his staff learn basic Spanish so they can better communicate and understand their Spanish-speaking patients. “I tell them it’s never too late to learn another language,” he commented. Flourish Research also developed a Diversity Workstream, which was broken down into two subgroups. One of the groups deals with diversity and inclusion in the workplace because people want to share their stories, they want to be celebrated and it’s important to understand their cultural background. “It’s two different things that we’re dealing with – patient diversity and also diversity and inclusion in our in our workforce.” Mohammad Millwalla, CEO of DM Clinical Research shared that “diversity has become a mission, not only from the industry standpoint but also internally.” With more than 600 employees, DM Clinical has created a staff community that is 74% diverse – and that’s just the starting point of their diversity initiatives. The Value of Brand Ambassadors Last year, DM Clinical Research had a study that hoped to enroll 1,000 diverse participants. The organization knew that just advertising is not going to make it happen, and they needed to do community outreach. During their outreach at multiple health fairs, they found an amazing individual named JR, who was African American. JR decided to become an ambassador for DM Clinical Research and suggested they join him at his ballroom dancing classes. JR then led a lunch and learn with the DM Clinical team sharing information about clinical trials where they enrolled 17 out of the 23 attendees. “JR has helped us make different videos for better awareness of inclusion and diversity for the African American community, and that has really served as well,” added Millwalla. They then duplicated this strategy in other locations, which were all a success. “What we learned from that idea was that if you want diversity, then you’ve got to listen to the people, let them lead, and let and help them operationalize their story and their idea.” Although the ambassador program was started in 2020, it didn’t really take off until they had established relationships with key ambassadors throughout their regions and communities. Their ambassador program features an interactive community-building app where ambassadors can communicate with one another internally and externally. Taking the First Step It’s important to keep in mind not all sites may have the infrastructure or resources to do community outreach. How can sites take the first step to enable diversity and inclusion within their organizations and trials? First, do intel in your communities. Know your community demographics so your enrollment can reflect the availability of different participant groups in your area. Your staff can be your champions. Have them reach out to their friends, family, and acquaintances and educate them about clinical research, and ask them to be involved in some way. Remember it’s not just about being a research institution – it’s also about being a health advocate. Clinical trials aren’t just about finding new treatments; they’re also about giving patients hope and improving their quality of life. Sites can also reach out to organizations like Latinos in Clinical Research or Black Women in Clinical Research that can help provide ideas and strategies for better community engagement. Work with local physicians. Sponsors and CROs can also appoint a diversity ambassador or liaison that can train sites, provide funding and help them break into new communities. By creating a space for diverse voices to be heard, we can learn from each other and identify ways to improve. Eden Stein’s organization, Centricity Research, created a diversity advisory council to talk about what their community does, how they feel about clinical research and break down some of those stigmas. “We need to do a better job with defining what diversity is; it’s not just diversity, it’s also inclusion,” said Marquez. It is through initiatives like these that we will be able to create a more equitable research environment and improve patient experiences worldwide. Join us at the annual Diversity Site Solutions Summit as we share more resources to advance diversity, equity, and inclusion in the clinical research industry. The Sites NOW program is designed to provide a platform for discussing stories and solutions for site success. Throughout the one-hour session, panel members discuss hot topics impacting the clinical research industry and best practices that organizations can use to prepare. Sites NOW is a space for all of us – researchers and practitioners alike – to come together and share our thoughts on how we can enable greater site success and sustainability. Everything discussed during the program informs further research down the line in white papers, articles and sessions at upcoming Summits. Register for the next Sites NOW and watch the meeting recording below.

In October, SCRS came together with more than 1,200 clinical research professionals at the Global Site Solutions Summit to commemorate 10 years of advancing site success. We also celebrated forward-thinking organizations creating innovative solutions and partnerships advancing the clinical trials industry. In the November Sites NOW discussion, 2022 SCRS award recipients highlighted the initiatives and strategies that helped them stand out and earn well-deserved recognition. Putting patients at the center In 2021, DM Clinical Research decided to implement data-driven decisions to enrich the patient journey.  Patient-focused practices were already a core value of this year’s Excellence in Patient Centricity award recipient, DM Clinical Research, but they wanted to take that value a step further by making it a strategic goal. Hera Arham, Director of Marketing & Patient Engagement at DM Clinical Research, shared that they first worked to identify roadblocks and pain points their patients experienced. Through a sophisticated tracking system, they created an internal dashboard to identify issues at each site with the goal of changing staff behaviors to be more mindful of the patient experience. “Using data to operationalize patient centricity is the key,” said Arham. “How do we innovate to become a patient-centric company if we don’t have the data and tools?” DM Clinical then created a dedicated patient engagement team that was responsible for assessing, improving, monitoring and reporting on the end-to-end patient experience. Additionally, DM Clinical established an additional customer support team to manage real-time calls for all patient inquiries. This team answered questions ranging from transportation to the clinics, trial compensation, communication with staff, and even eDiary or compliance issues. Within the first six months, the dedicated team answered more than 17,000 phone calls that would have been missed and resolved 1,000+ patient issues in real time. Gathering patient feedback was also critical for DM Clinical. Patient input was collected through a combination of automated surveys and spot-individual interviews after each interaction. This allowed unfiltered contact with patients that were enrolled or considering enrolling. Scorecards were created for each site that measured Google reviews, focus group data, and survey data. The scorecards were reviewed by both site and leadership teams to determine solutions needed for improvement. Patient retention and referrals increased after implementing these practices. “Our shared-decision making helped us create a more patient-centric approach to identifying common trends and unique situations that impacted the way participants perceived research, DM Clinical, and medicine in general. We knew changing the culture within an organization to be more patient-centric meant that we’d need to support the change through reliable metrics and KPIs. Real data helps identify blind spots and track progressive improvement. At DM Clinical, we knew one thing to be true – we all needed to become patient advocates,” said Arham. Moving the needle in diverse community outreach and recruitment Javara, recipient of the Site Patient Recruitment Innovation Award (SPRIA), developed a recruitment plan to reach a variety of patients through different mediums, including social media advertising, doctor-to-patient email marketing, direct mail and newspaper ads. “Innovation isn’t just technology; it’s about taking existing processes and making them better,” shared Mike Clay, Chief Operating Officer at Javara. The recruitment efforts prioritized community engagement and human interaction. They worked with the non-profit organization Greater Gift to support this component. Greater Gift’s mission is to increase awareness of clinical research, especially among underrepresented communities. This partnership allowed Javara to develop relationships within diverse communities. By developing relationships and cultivating a community before recruitment efforts, the patient population was more receptive and in turn, Javara and SouthCoast Health were able to exceed enrollment for this study and increase diverse patient participation. Increasing the clinical research talent pool As we learned in the August 2022 Sites NOW discussion, there is a significant gap between the number of jobs available for clinical research coordinators (CRCs) and the number of qualified staff to fill those positions. To address this, Site Tank Award recipient UC Davis Health School of Medicine – Clinical and Translational Science Center (CTSC) developed a program to train the next generation of clinical research staff in 16 weeks. In collaboration with local community colleges, Medix, and UC Davis Health’s Diversity and Inclusion program, a pilot training program was launched to address the persistent shortage of CRCs and increase diversity of the clinical research workforce. The comprehensive training program also opened a pipeline to STEM careers for people historically underrepresented in these fields. Stipends, internships and shadowing opportunities were provided. This was the first comprehensive CRC training program administered by a public-private partnership. The program was unique in that it offered a combination of classroom learning with workplace exposure to clinical research processes. After completing the training, Medix helped place the clinical research coordinators in open roles with UC Davis or other organizations. UC Davis plans to expand the program by collaborating with more colleges and organizations nationwide. Site-centricity from the CRO perspective As the 2021 and 2022 recipient of the Eagle Award, PPD, part of Thermo Fisher Scientific, has been prioritizing site-focused approaches to everything they do. A more recent initiative by PPD has focused on improving training for sites that are new to clinical research and help those sites gain experience to earn more trials. As more sites adopt decentralized elements in their trials, PPD actively requests feedback from sites on how to make DCTs better overall and acts on that feedback. Diversity is another critical need for the industry that PPD is prioritizing. For diversity efforts, they have been working with sites to determine their needs for better diverse enrollment and developing programs to adapt to those needs. What can sites do to stand out and be noticed by CROs? Lisa Dyment, Senior Director of Site Collaborations at PPD, part of Thermo Fisher Scientific, encourages open dialogue and staying in close contact with the sponsor and CRO. “Have open dialogue with your points of contact at the sponsor and CRO. Be very honest about your enrollment objectives and what you can realistically achieve. Give feedback. Let us know what you like and don’t like about the study and challenges you might be facing. As an intermediary, we may not always have the power to make changes in a study, but we can definitely commit to passing the message along,” added Dyment. Establishing consistency at the sponsor level After the world was turned upside down from the pandemic, 2022 Eagle Award recipient Merck decided to get back to basics, working to analyze and understand the areas where sites needed support the most. Merck asked their sites about their pain points and then developed a strategy to step up to those needs. Sites have consistently asked for single points of contact for both CROs and sponsors, and Merck delivered in an especially critical area: budgeting and contracts. Merck appointed one person to negotiate budgets and contracts with each site, so that sites would only have to communicate with one person. Another initiative kept CRAs at the same sites to establish relationship, cadence and familiarity. Additionally, Merck created a dedicated, real-time technology support team to help sites with onboarding and implementing new technologies. Amplifying the voice of the sites Viviënne van de Walle, the Christine K. Pierre Site Impact Award winner, has been a huge advocate for SCRS and clinical research sites for decades. As an SCRS Leadership Council Member and European Site Solutions Summit chair, she is a remarkable leader and voice for sites around the world. Improving lives of patients is at the heart of Viviënne’s work, and improving processes at sites and throughout every stage of clinical research is a large part of that. Vivienne shared that clinical research stakeholders are understanding each other’s sides of the story by coming together often and communicating openly through mediums like Site Advocacy Groups, online and in-person events, and the SCRS online community. Congratulations again to all of the 2022 award recipients and finalists! Learn more about each award at sitesolutionssummit.com. Watch the replay of the Sites NOW discussion here:

What does the clinical research workforce look like right now?  It’s no secret that the workforce shortage in clinical research is a significant industry issue. Nicole Mills, SCRS Education and Knowledge Management Lead shared that according to CareerBuilder, there are currently 6.6 million clinical research jobs posted in the U.S., yet only 5.7 million available hires, which means almost one million more jobs are available than talent available nationwide. The issue is exacerbated when companies need specific skill sets or experience levels.  For every 1 clinical research coordinator (CRC) looking for a job, there are 7 jobs posted. For nurses, it’s a 1 to 10 ratio. For regulatory affairs, it’s 1 in 35. These numbers can vary drastically by city or state as well. For example, when looking at data for California, there are 5,000 clinical research jobs but only 1,400 clinical research professionals looking for jobs.  As of July 2022, there were 62,000 new job postings for clinical research roles and 17,000 of them were “unique” – meaning they didn’t fit a traditional clinical research coordinator-type role. Companies are diversifying traditional roles of coordinators while adding more roles such as home health nurses, IT compliance, regulatory data management, and other positions for adapting to new technologies and protocols.  Bridging the gap  Sites are having to get creative when it comes to hiring, whether that be salary negotiations or offering additional incentives such as hybrid scheduling or remote work. Additionally, sites in certain cities where the cost of living is higher are having to offer increased salaries to recruit new staff. These same sites are often competing with CROs and Sponsors that have higher budgets for salaries and sign-on bonuses, which can make recruiting especially challenging. Out of the 2,400 open positions that listed salaries, $82,000 was the median salary for a clinical research coordinator, with the range anywhere from $40,000 up to $120,000. David Vulcano, SCRS Honorary President and Vice President of Research Compliance and Integrity at HCA Healthcare shared that compensation has increased approximately 40-60% from pre-pandemic levels, which not only includes salaries but also retention bonuses and other benefits.  Not all sites can meet the salary and benefit options that other organizations may offer, which contributes to high turnover among site staff. SCRS gathered anecdotal data regarding site staff retention and found the turnover rate has increased 2-3x from pre-pandemic levels. When study coordinators leave, it can take 6-12 months for sites to get back on track with that study.  SCRS and industry partners have discussed offering a study continuity plan to help minimize the impact to the site and study when coordinators are recruited by a Sponsor or CRO. The continuity plan would be offered by the Sponsor or CRO if that organization recruits a coordinator from the site.  Many organizations are having to adjust expectations for the roles they need. They may hire someone without clinical research experience but with therapeutic area experience or vice versa. Looking for transferrable skills from a general healthcare background or other industries is also becoming more prevalent. Candidates with experience in project management, administrative, or technology-related roles are helping bridge the gap. However, those hires typically require additional training on all the aspects of clinical research, which some sites may not have the time to manage.  Taking action  How do we alleviate some of the training issues for sites and make it easier to hire people who have less experience, or that come from other industries? SCRS created a Workforce Task Force with a site toolkit to help address this issue. The toolkit shares solutions for sites to train more efficiently, retain current staff, manage budgets and cash flow, and what additional benefits to consider such as childcare, more flexible schedules, work-from-home days, transportation options and employee recognition programs.   Ultimately, we need new avenues into our industry. Awareness of clinical research is at an all-time high due to the clinical studies involving COVID-19 vaccines and this can be used to encourage more people to enter clinical research. Working with nurse education centers and universities is underway for several industry organizations already.  The workforce will continue to be a hot topic of discussion as we look for more solutions to address current challenges. Watch the Sites NOW discussion recording here and join us for the next Sites NOW meeting to be a part of the conversation! 

Clinical tech has been evolving at a rapid pace to solve study-facing challenges. At the 2019 Global Site Solutions Summit, SCRS hosted a Global Impact Partner meeting where we asked, “what is the one priority that our industry needed to heighten awareness and prepare for as we approach 2020?”  We left that meeting with an understanding of decentralized clinical trials (DCTs).   “I can’t imagine if we hadn’t prepared for some of that work,” commented Sean Soth, VP of Global Business Partnerships for SCRS. “We worked hard on virtual capabilities, educating the market on what DCTs were. But that’s just one small example of technology that still has many questions.”  While the industry has seen exciting advancements in DCTs and even more technology is being added to the alphabet soup of innovation, sites find themselves in the age-old problem of being asked to do more with less or not enough.  It’s not just investment that matters – it’s the ongoing barriers to training, implementation and user experience that continually impact research site operations and outcomes. Technology innovation often gives way to burden without the insight of practical approaches and understanding of how sites will apply these solutions. The ideas shared in this Sites NOW discussion will explore how we can narrow this gap.   The most important needs in clinical tech right now  Panelist Gary Schwartz said that finding end-to-end solutions that are more platform-based or provide a one-stop shop for sites is a strong trend. This eliminates linkages and interfaces between data modules and applications, as well as the number of site logins required to access various systems. Being able to simplify not only the vendor relationship and management, but the interactions with those technologies, is a critically important need. This will help sites simplify their interactions with a particular trial, as well as the patients participating.  Industry is also looking at how they impact the patient because in the end, that is most important. How do we simplify those interactions? Patient centricity is mentioned frequently across the industry, but awareness is growing that patient-centricity can’t happen without site-centricity. If sites can’t attract patients, then all stakeholders in the industry suffer.  How can site centricity and patient centricity coexist?   With the currently growing shortage of staff, sites want to leverage technology to help them optimize their internal operations so they can focus more on patients. The goal is for technology to help site staff spend more time on higher-value tasks.   However, because all the technology systems may not communicate well or may not perform as well as expected, sites end up spending significantly more time than anticipated using different platforms. “Sites end up actually taking a step back when they were hoping to take a step forward,” said panelist Henry Kravchenko. “That’s a painful thing to see because you should be adopting technology that helps you move forward. If it’s not doing that, it’s a structural issue that needs to be dealt with on multiple levels.” Panelist Shivani Shah shared a site perspective. What are some of the higher-value tasks that sites are hoping systems will help them solve?  Shah agreed sites need platforms that are end-to-end and simpler for both sites and patients. In the same vein, one of the bigger problems sites are trying to solve is remote and hybrid visits and how technology can support that. Sites need technology that’s easy for them and their patients to use while providing more visibility and oversight for investigators.   Vendors that have a suite of options, versus individual vendors that capture certain data, are becoming more attractive to industry partners as well.  “Our challenge right now is that we have a few different softwares that we’re working on in terms of our functional requirements. The next step is how to make sure to have all of this on a consistent platform,” said Shah.  To elaborate on remote and hybrid visit needs, Shah shared that sites are looking for more technology infrastructure around the shipment of labs, making it easier and more convenient for the patient and providing sites with more visibility in ensuring the protocol is followed.  E-consent is also one of the recurring hot topics of discussion for industry. “From the site and patient standpoint, we’re still experiencing growing pains where we have multiple options to work with, but it’s not airtight. We see the benefits of it, but oftentimes we have seen that it increases visit duration, especially for elderly patients,” said Shah.  When and how do sites introduce new solutions to their team and locations? Shah commented that when introducing options for the team, they have a dedicated department that is constantly looking for innovative ideas and strategies. “It usually goes to a pilot phase of introducing it, trying it out with a small team and a smaller site, and then getting all the stakeholders involved with their feedback.” Committees would also be a great option for sites or industry partners that want to share technology ideas and experiences.   Reflecting on how far the industry has come, panelist Mark Ryan shared, “I’ve been doing this a long time – over 25+ years – and was a coordinator before I came to Bayer. I remember some of our biggest concerns back then were where the sealed randomized codes in the envelope were going to be stored at a site. Where do we put that? How did we get signatures on delegation logs on a piece of paper? We had to fax them around to different people to get signatures. Those were big technology challenges back then.”   Today, there are shiny new objects for clinical trials coming out every week. People want to do things differently and try to make life easier, but it’s getting more complicated and even more challenging. “It’s not just challenging for sites – it’s challenging for Sponsors and patients as well,” commented Ryan. Introducing new tech to sites  Ryan also discussed what his organization, Bayer, is doing when preparing to share new technology with their site partners, adding, “We’re trying to keep up with what we need to do to be better. Because at the end of the day, we’re trying to get medications to patients that need them faster. Along the way, we created some challenges for ourselves that were hard to overcome.”  There is still a lot of trial and error that happens along the way when bringing new technologies to sites and ensuring they work as needed. One of the big takeaways Bayer has heard through site feedback is many sites don’t know about the technology needed for their trial until they get closer to getting that site open. “Often, we don’t know which technology we’re going to be using, or which vendors we’re going to be using when we’re doing feasibility. We’re trying to get that moved up earlier in the process so sites can make an educated decision based on the technology needed for their study,” expanded Ryan. What technology should sites own as opposed to being needed by Sponsors? Shah shared that sites should have more say and ownership in areas of studies that are patient-centric, especially with e-consent and e-diary technology. “It’s less of an imposition if we can work together.” New roles to support technology needs  Training and site support are high on industry’s list of priorities. If there’s an issue, how do we stop the finger-pointing between technologies? CROs should consider having specific roles to help sites with technology-related questions. Ryan added that the CRA may not always be the best person to deal with technology inquiries, so Bayer has created specialist roles that manage technology on a more repeated basis. Schwartz echoed that industry is looking for people that can manage solutions across the enterprise and recommend technology platforms for trials. It takes special skill to understand all the available options when selecting which decentralized clinical trial technologies are right for a particular protocol. Specialists are currently needed to handle the study startup functionality – writing the specs, working with the vendors to make sure they’re developed correctly, and that they’re operated properly going forward. If CROs put people in place to help solve those problems, then over time that expertise will be disseminated amongst the organization and there will be less need for that specialized function.   The volume of tech  60% of sites polled in the May Sites NOW meeting said they are using 20+ systems on a daily basis. However, that number increases even more when considering other systems that are needed less frequently.   What happens when a site is already using certain technologies and the Sponsor asks the site to use a different vendor for the same technology? Sites expressed that they have turned down studies due to not agreeing with protocol technology or vendor requirements, and that trend may continue to increase as more technology options emerge. Sponsors should remain flexible and communicate early with sites to manage this. Schwartz added, “There are so many players involved in the decisions, and what’s best for each organization comes down to a desire to have a common understanding of how we move forward in a cohesive, efficient manner. For example, if you’re trying to attract a site that has a very rare population, there may be more flexibility. In the old days, it seemed to be a ‘my way or the highway’ approach to attracting sites and I believe that has changed dramatically. How do we work together to solve some of these problems so that we can all move forward? We try to create those avenues of interaction with our site partners so that we can get that feedback and understand how to make our organization easier to do business with.”  One of the challenges in the clinical research industry is there are many vendors trying to address the needs of all stakeholders simultaneously, and it often doesn’t work. There are different types and sizes of sites with different needs, so the same solution might not be applicable. It’s especially important for technology providers to adapt their solutions based on the customer and end user. The core infrastructure should be the same, but have the ability to serve multiple stakeholders in a way that fits their business model.  Designing the ideal study  If you could design your next study from scratch, what would you do to change your approach to technology?  In the breakouts, we discussed this very idea. One idea shared was open APIs so technology providers could share data securely with one another and reduce redundant data capturing that is required for different systems.   Have sites involved early in the protocol development to decide what technologies might be the best fit. Even solution providers should consider getting input from sites as well. SCRS Site Advocacy Groups are a great avenue for garnering site feedback. Invite sites to test beta versions of the platforms, make tech support available 24/7, and available in multiple languages.   Eliminating redundancy in training is also a substantial need. The industry would benefit from competency training that can be applied to multiple vendors and technology platforms.  Duplication of training programs could be eliminated via common globally standardized, and industry-accepted systems where information and documentation of competencies can be commonly shared in order to eliminate redundancies and burdens at the site level. Do you have feedback to share on this topic? Consider joining us at an upcoming Site Solutions Summit or Sites NOW discussion.   Watch the full Sites NOW meeting recording here. 

The phrase “patient-centricity” has been circulating the healthcare and clinical research industry for quite a while. What does patient-centricity really mean and how can we ensure our practices are meeting and exceeding that definition?   The March Sites NOW meeting tackled all things patient-centricity and discussed practices industry can implement now to impact study success.  Improving Study Design from Start to Finish  In a Sites NOW poll, 49% of respondents said they currently have patient-centricity policies and procedures in place, while 30% have procedures in development, and 21% don’t have any patient-centric procedures in the works. Patricia Roselle, Sanofi, stated that before you consider exploring any patient-centric processes, keep in mind the strategy should span all the way from pre-trial to post-launch. It’s an ongoing process that involves conducting surveys throughout the study, asking open-ended questions about patients’ research experiences, and following up every six months with surveys.   Getting feedback at the end of a study is too late – if there are trends across sites, protocol amendments should be considered. We can’t assume things are still working well – we need to get feedback continuously.  Learning throughout the trial and acting as quickly as possible to implement any needed changes will have a massive impact on patient retention.    Health authorities and industry are experiencing a learning curve to understand how science can be fused with patient insights for better integration. Traditionally, sponsors have known the simplest way to implement patient-centered initiatives is to start at the study design phase to reduce burden.  When looking at study design, consider how it impacts Diversity, Equity and Inclusion (DEI) efforts. Some long-standing inclusion and exclusion criteria are inherently biased and severely limit potential participants. Address this by ensuring protocols are easier for patients to qualify for participation in studies. Although protocol amendments can be a pain point, they are incredibly important when they impact who can be included in a study.  The patient experience can also be improved by reducing patient/caregiver inconveniences through means such as providing transportation, reimbursement, and home health care options.  As part of industry’s collective efforts to make clinical research more understandable and approachable to the general public, we need to keep in mind that patients are people. How do they feel about the term “patients”? Industry can create more comfort by asking patients how they want to be referenced.  Creating patient-centric practices is usually a budget issue, so industry partners need to walk the walk and support it in every way on a project basis. If CROs are unable to allocate additional funding for a particular study, keep it top of mind for future studies.  Patient Champions  Patients, sites, CROs, sponsors and vendors all need to be a part of the conversation in order to make patient-centricity a reality. This means all stakeholders need frequent site and patient feedback to better understand patient experiences. It’s not something only one arm of clinical research can tackle, as Sites NOW panelist Ellen Price mentioned. “Without collaborating with sponsors and CROs, we wouldn’t be able to bring these patient-focused plans to fruition.”   Sites, find your like-minded, patient-centric champion who shares your values and can have conversations around patient engagement programs. Ask your CRO partner to connect you with the right person who will be your partner/advocate and communicate patient needs and feedback to enact change. Be persistent! CROs value hearing from sites and may not get to speak to them often, so your input is important.  What is our industry missing with patient centricity and how can we help change?  After the presentation, Sites NOW attendees divided into groups for further discussion to share thoughts on what industry is missing with patient-centricity.   One insight is that not everyone wants to do things the same way, so flexibility and options for patients are important. Additionally, industry tends to group patients in specific therapeutic areas together and generalize their needs without considering individual patient barriers. We need to understand the patient before writing a protocol.  Listen to sites in the early stages of protocol development for input on what may or may not work. Site Advocacy Groups are a great tool for this. Also, industry needs to consider how sites will manage flexibility options operationally.  The conversation was mixed in regards to finding a balance with technology use in trials. We’re adding many new technologies to studies, but are they all patient-centric? Technology can add a lot of stress on study coordinators to manage, where 30% to 40% of their time is spent at the computer dealing with technology. Tech support services are needed to remove this burden from sites. Consider what can we offer through telehealth and other virtual means to assist patients with accessibility, keeping in mind simplicity is the key for both sites and patients. As the industry looks to implement more patient-centric approaches, we also need to consider how to provide meaningful support and services to patients without adding burden to sites.  If you want a glimpse of what participants experience in your trials, “Volunteer to be a research participant yourself to experience the process.”  The full meeting recording featuring Patricia Roselle from Sanofi, Lisa Dyment of PPD and Ellen Price of Meridian Clinical Research is available to view here. 

The Sites NOW January discussion, featuring panelists Peter Fredette of IQVIA, Rosemary McQueary of Quality Cancer Care and Alliance, and Alexa Florea from Roche Genentech, highlighted insights gathered from recent oncology research site surveys, acincluding trends and issues impacting the future of research. Peter Fredette, who has worked in oncology research for nearly two decades, kicked off the conversation. “The oncology research industry is incredibly resilient. Anyone in this field can feel the urgency to get back to work, whether we do it remotely or standing on our heads. But more importantly, we’re going to try and do it better.”  Within oncology clinical research, some things were put on hold, delayed or canceled due to the pandemic, but recovery has been swift: there are currently 740+ companies focused on oncology R&D and more than 500 of those are focused exclusively on oncology R&D.  Despite disruptions with COVID-19, there were 1,600 clinical trial starts over the last two years, which is an all-time high. There are also ~3,500 new drugs in the pipeline to be studied, which is unprecedented. This is up approximately 75% from 2015 numbers.  How has oncology research changed over the last few years? For starters, protocols are more complex. Procedures and data collection are increasing. Many trials are now requiring smaller subsets of patients. Additionally, oncologists are spending 20% of their time discussing COVID with their patients, which is adding to their already increased workloads. (Information on these statistics is available in the annual IQVIA Oncology Trends Report). What are the biggest issues facing oncology sites today?  Staffing Issues Remain a Challenge  According to WCG survey of site leaders, three out of four said that staffing is the most prevalent challenge in research with 1 in 5 stating staff turnover rates are 30% or higher.  In one Sites NOW January meeting poll, 80% of sites said staffing is not where it needs to be for effective operations, and 55% of sites have turned down studies due to staffing issues. Because of these challenges, 70% of staff said they have experienced a significant reduction in time available to manage patients.  The number of PIs has also dropped significantly in the past couple of years from about 15,000 to 10,000. The main causes cited include burnout and the work to do study start-ups is becoming too burdensome. Sponsors are prioritizing established investigators and may overlook new investigators, but it’s imperative to get new PIs involved in research.  At the 2021 Global Site Solutions Summit, this was a hot topic of discussion where speakers suggested reaching out to medical schools, starting internship programs, training staff from within, and offering classes as suggestions to get started.  Technology  Clinical trial technologies – wearables, eConsent, eCOA, etc. – are being piloted in trials more than ever before. Many sites have participated in decentralized trials (DCTs), but panelist Rosemary McQuery commented that remote visits still require the same amount of attention and work as onsite visits. This is especially important to note as a recent SCRS survey showed that only 7% of sites feel they are being adequately reimbursed for time and effort in DCT implementation.   How will the CRA role evolve? McQuery shared, “We have a practice that just hired a screener who will be working remotely from another state. How much pre-screening can we do in a patient record without physically being onsite? AI has been helpful for oncology sites to narrow down patient lists and conduct pre-screens in a more focused way. However, no AI will be able to tell 100% accurately if a patient does or does not qualify for the study.”  Despite the efficiencies tech creates, we also must consider how they are implemented. Required staff training for new clinical trial technologies and platforms is creating an increasingly time-consuming burden on sites. Sites NOW panelists reiterated that digital competency is not an issue for site staff; the issue is the number of platforms and technologies being introduced which require separate training for each. More open communication between sites and industry is needed to address opportunities to improve training and budgeting for new technologies as they become more widely used.  McQuery would also love to see an assessment tool to analyze staff workloads. How much do you need to increase staffing to increase workload? How many people do we need to conduct these trials?  Looking Ahead  Oncology sites are exploring using mobile nurses and hiring outside of the clinical research industry to address the present issue of staffing. Increased collaboration will be huge to develop a better future for oncology research. This includes site network partnerships, site-CRO partnerships, and working with regulators and regulatory agencies. Panelist Alexa Florea urged sites to speak up and share feedback to sponsors and CROs. “Teach others what you need. Sites, be adamant about what it takes to run a trial,” said Florea. “Partnership is a way out of the muck. But you have to speak up.” Research is hard and ever-changing. There are many opportunities for learning, growth, and efficiencies. Starting conversations now to ideate how we can move forward together will improve research for all. Plan to join us at the 2022 Global Oncology Site Solutions Summit May 21-22, 2022 at the Hilton Austin in Austin, Texas.  Watch the recording of the January Sites NOW session

In November, we reconvened for Sites NOW to discuss the 2021 SCRS Global Site Solutions Summit and some of the highlights from popular sessions. Lindsey Morales of Labcorp Drug Development, Ana Marquez of Clinical Site Partners, and Karin Gulbrandsen of Janssen joined us to share lessons learned and hot topics of discussion in each session.  It’s Not You, It’s Me: How to Manage Long Term Partnerships As the pipeline of clinical trial work evolves and changes over time, the importance of quality relationships between sites and sponsors and CROs will increase. Sponsors and CROs will engage sites that align with current and mid-term projected opportunities and remaining in contact over the long-term will become even more important. Attendees gained insight into navigating clinical trial evolution to position their sites for success. Chris Hoyle of Elite Research Network facilitated the session with panelists Silvina Baudino of Teckro, Lindsey Morales of Labcorp Drug Development, Robyn Schmidtke of Merck.  Fundamentally, this session focused on communication. As we know, partnerships of any type are all about communicating with and learning about one another. But, what does it mean to communicate? What does it mean to be honest and build trust with one another?    Sites, speak up! Sponsors and CROs want sites to share information and challenges because “if they don’t know about it, they can’t help you with it.” Keep conversations going about training as the industry looks for solutions to minimize the amount of training needed for new technologies and reduce overall technology burden for sites. Be open and candid and transparent about the things we’re learning with each other.   One popular point of discussion sites shared was that CRO databases seem to be places where information just goes into a black hole. Industry is incorporating site feedback and working on better databases to keep everything in one place and reduce redundancies, so please continue providing feedback.   We also shared how crucial it is for our industry to attend meetings and conferences to take communication to a new level by putting a face to a name and building a personal connection.  Industry conferences, virtual meetings, site advocacy or focus groups, and community forums are a great place to foster relationships and provide value to one another throughout the year. Continue reaching out to sponsors and CROs to find people you can partner with and who will be an advocate for your site. They want to know you and help you as much as they can, so don’t be afraid to ask for assistance or contacts if needed.  Hybrid Decentralized Trials: Critical Considerations   It’s no secret that digital innovations are here to stay, especially in the form of decentralized trials. While there are important considerations to be made from an administrative and process perspective, it is equally critical that we consider how patients will be affected. This session discussed how decentralized trials affect patient interaction so we can ensure patients’ needs are addressed.  Facilitated by Todd Albin of Cedar Health Research, panelists included Deena Bernstein of Datacubed Health, Nicole Latimer of Medrio, Scott Connor of Signant Health, and Karin Gulbrandsen of Janssen.  Understandably, sites remain concerned about building and maintaining patient relationships when using DCTs. However, the intent of decentralized clinical trials (DCTs) is to engage patients where they are and increase retention. Many opportunities remain to build relationships with trial subjects in different ways and may be nourished through a combination of phone calls, video calls, texts, and in-person visits.  Sites are also apprehensive about PI oversight specific to DCTs due to lack of understanding of regulations. PIs still need to make sure they are delivering quality expected from in-person visits, while industry needs to provide guidance for investigators as they navigate these new expectations.   It was also shared that sponsors and CROs need better understanding of financial liabilities for sites regarding implementation of new technology. Sites expressed that budgets are often poor with DCTs, yet add a lot of work for the site.  Additionally, many digital platforms ask for specs, then other sponsors or studies ask the same information again. Communicating these challenges can help industry to create a uniform way for sites to provide technical authentication pieces in the future. It’s important to remember that adding new technologies to trials is not one-and-done; as we implement different elements, we need to continue to get the feedback on what’s working and what’s not. It’s an ongoing learning process that will only be successful if sites and industry work together to find solutions that benefit all.  FDA Audits: Yes, That Really Happened!  FDA audits are an inevitable reality that all sites should be prepared for before they are audited. This session included perspectives from those who have experienced FDA inspections to share how they prepared for the audit and what measures they have implemented to ensure future inspection-readiness.   Ana Marquez of Clinical Research Partners facilitated the session with panelists Shivani Shah of DM Clinical Research, David Vulcano of HCA Healthcare, Rick Arlow of Complion, and Lisa Kodis of Illingsworth Research Group.  This session discussed recent FDA audit need changes and what the FDA is looking for, such as informed consent issues and delegation log issues. How do sites prepare for audits? Panelists noted that it is critical to prepare site staff by discussing specific steps to take after being notified of an audit. Sites should identify a key team for inspection and minimize involvement of too many people as much as possible. One option may be to hire an expert to assist you with the process, especially if you have been issued a 483. Investing in the proper individual to guide you through it can make it a much easier process for your site.  It’s also important to note that sites can set limits in their contracts when it comes to FDA inspections regarding communications protocols,  such as only notifying the sponsors whose trials will be affected by an audit.   SCRS will continue to host workshops, webinars, and provide resources for sites to self-monitor and be as prepared as possible for FDA inspection. FDA also offers an audit manual online that industry can pull which shares every question to anticipate the auditor asking.  The meeting then separated into breakout sessions to discuss  takeaways from these sessions and the 2021 Global Site Solutions Summit. We hope you will join us for the next Site Solutions Summit and encourage you to get your tickets as early as possible to secure the lowest rate! For the full November 2021 Sites NOW discussion, watch the Sites NOW meeting recording here.