Resources & Training

Uncategorized

Category

Diversity Beyond Quotas: Intersectionality, Authenticity and Respect

By Rachel Baldwin, Associate Product Marketing Manager, Teckro When it comes to the importance of diversity, equity and inclusion (DEI), we all welcome the acceleration in global awareness and discussion. For the clinical research industry, finding common ground among sponsors, sites, patients and community advocates is a critical first step to expanding DEI conversations. Whether it’s reading a “good news” story or learning from things that missed the mark, one key factor is universally clear: it is paramount that those occupying underrepresented demographics and identities are central and present for the conversation. Finding Common Ground: Clinical Trial Inclusion from Perspectives of Sites and Patients is our most recent webinar hosted by the Society for Clinical Research Sites (SCRS). Teckro’s own Director of Site Engagement Silvina Baudino was joined by Luckie Alexander, founder of Invisible Men and LGBTQ+ advocate, and Chris Komelasky CEO and co-founder of SiteBridge Research. Silvina, Luckie and Chris explored topics including: The multidimensional approach needed to achieve true diversity, equity, and inclusion Specific LGBTQ+ community barriers to clinical research participation What clinical research sites are doing now and could be doing in the future What further meaningful actions can improve inclusion of traditionally underserved patient communities in clinical research Centering Intersectionality Silvina started by outlining the current clinical trial industry state of affairs. The most recent draft guidance from the FDA on equitable participation for individuals from underrepresented racial and ethnic populations is an excellent step and will help to move the needle. However, we need to remember that people are multidimensional and often occupy intersecting identities. Particularly if we consider the LGBTQ+ community, they are often only considered for clinical research around HIV and sexual health, which limits engagement and overlooks clinical trials as a care option for other conditions and disease areas. Silvina also discussed findings in a report published by Teckro of experiences and interactions with clinical research and healthcare shared by LGBTQ+ patients and community members, which is the result from a virtual advisory meeting facilitated with the Center for Information and Study on Clinical Research Participation (CISCRP). The report also explores the insights and recommendations for improving future patient experiences in clinical trials. As both an LGBTQ+ patient and community member as well as a clinical trial recruiter, Luckie has an interesting insight into both sides of the study participation coin. Luckie was one of the advisors in the LGBTQ+ focus group hosted by CISCRP. He shared that for trans or LGBTQ+ folks, language and awareness of unique challenges are key to increasing trust. Gendered language excludes members of these communities by default, for example “women’s health” topics fail to account for trans men who could still be impacted by and/or need treatment for reproductive health issues. Luckie has found in his role of recruiting patients that even as a community member and trusted messenger, people are still hesitant to participate in clinical research. The starting point for many DEI initiatives has been heavily centered around race and ethnicity. While this is not a bad thing, a visible gap has existed for decades with a history of poor access and equity issues across many communities. The panel discussed how it is important not to pause at one identity, to be intentional, and to continually consider intersectionality. Download the report. Community Engagement: Not Another Term for Patient Recruitment Another hot topic is authenticity. It’s widely recognized that popping up in community spaces and just attempting to recruit clinical trial participants off the bat has been poorly received and largely unsuccessful. From the site perspective, Chris discussed the transactional nature of participant quotas and breaking the paradigm of study specific recruitment. SiteBridge Research’s framework for community engagement strategies focuses on sustained connectivity and trust. As ever, listening is key. Chris expanded on the need to be early, authentic and consistent when engaging with a community, and to do so in a broader, omnipresent manner – not as a specific, budget-constrained, outreach for an individual study. This supports an impactful network approach before studies even happen and builds roots and trust in those communities ahead of time. SiteBridge Research offers a toolkit for talking about clinical research, and also has a Champion Program, where champions help dispel misinformation, provide education and strengthen community connections. The toolkit packages general disease guidance, health literacy and clinical trial information and can be shared with community leaders for dissemination. Assorted industry partners, such as CISCRP and Greater Gift, are working with SiteBridge Research to develop accessible, adaptable, multilingual content across these areas. With a continued reach, a champion network can be enabled and empowered. Community engagement should not be seen as another term for patient recruitment. Alongside using digital and virtual channels for raising awareness and disseminating information, there should be genuine, value-adding contributions in a face-to-face setting before recruitment is even on the table. This includes a presence at local events and activities, physical boots on the ground offering health information, and a safe place for questions and honest conversation. Later down the line, when trust has been earned, relationships fostered, and communication lines established, members of that community may be more receptive to clinical research as a care option and consider participating in clinical trials. Following that is when outreach may be enhanced with community advocates that help with spreading awareness. Individual and Organizational Responsibility With many DEI conversations and initiatives, there is an understanding that people can be afraid of saying the wrong thing, for example when interacting with or addressing an individual from the LGBTQ+ community, and that this may make some physicians or healthcare providers avoidant. The panel talked about individual and organizational level responsibility. Luckie shared his view that for a relationship with a healthcare provider to be both positive and feel safe, physicians need to take personal responsibility to learn about and engage with different communities to truly understand what they’re going through and what they need. At an organizational level, the key responsibility is to ensure feedback and input are captured from across an intersectional breadth of different communities and built into the trial design and study protocol. Additionally, there needs to be an embedded understanding of and commitment to diversity, equity and inclusion in the organizational culture. This includes providing staff DEI training and ensuring there are no barriers to organizational staffing opportunities for individuals or physicians from across diverse communities. Luckie further shared that while there are specific perspectives and nuances within different communities, what cannot be lost is the commonality of everyone just wanting respect. Communities talk to each other and while good news travels fast, bad news travels faster. If respect for all is embedded at the very core of an organization, then it will be known for being a safe space and the likelihood of positive community engagement is exponentially increased. Meet Teckro at booth #28 at the SCRS Diversity Site Solutions Summit, March 30-31, 2023, in Austin TX.

Placing Patients at the Heart of the Clinical Trial Ecosystem

Leads to successful trials & answering the needs of patients sooner Hosted by Sanofi, the Heart of the Entire Clinical Trial Ecosystem symposium explored what patient centricity means to sponsors and site investigators in February 2022. Patient-centric Clinical Research Following presentations from Victoria DiBiaso, Global Head of Patient Informed Development & Health Value Translation and Ellen Price, Director of Patient Engagement with Meridian Clinical Research, it emerged that patient centricity takes an ecosystem fueled by the insight, energy and passion of site investigators, sponsors, clinical research organizations and most of all, the perspectives and real-world experiences of patients. From a sponsor view, DiBiaso explained how Sanofi’s trials and clinical development programs are informed in alignment by the needs and priorities of sites and patients. With a key focus on trial optimization and simplification, Sanofi provides end-to-end support to sites, as they play a vital role in the clinical trial experience. Sanofi’s research environment considers health value for the global patient community and physicians in its commitment to patient centricity, starting from the pre-clinical stages through post-approval of new medications. Patient-informed trials and development programs are shown to bring meaningful healthcare solutions to patients faster and offer a vital source of hope to people without available treatment options. Intentionally establishing elements of clinical trials and research programs based on patient insights, patient-reported outcomes and diversity and inclusion strategies is necessary to make clinical trials part of people’s health care continuum. After learning, from patient advisors how difficult it is to find studies, Sanofi launched Sanofistudies.com in 2021, which allows people to find clinical trials in their US geographic location (soon to be expanded to other countries). To illustrate the scope of Sanofi’s integrated approach, patients and caregivers advised 57 programs with 67 unique disease indications between Research and Development. This covers 100% of its clinical trials and they collaborated with Patient Advocacy Organizations from across 33 countries in 2021 on the advisement and public awareness of those studies. Patient-centric Practices for Sites Community advocacy is a critical component of site’s patient-centric toolkit. Price highlighted the power of partnering with advocates to build bridges between communities and clinical research sites. Patient participant advocates can help increase trust and access to study opportunities by successfully raising awareness, supplying educational materials and reassuring people that steps are taken to protect the rights and welfare of patients. Advocates also bring feedback to Meridian and their network of sites about barriers and obstacles to participation, allowing for improvement of the patient experience and Meridian’s operational processes. The symposium concluded with breakout sessions for sites to share best practices on bringing the patient voice to the forefront of clinical trials. Several patient-centric trends at sites were raised, including fostering communication through patient testimonials on social media and local news channels, implementing decentralized clinical trials and collaborating on recruitment materials with sponsors. Watch the full recording here.

Site Staffing

As some research site employees look for growth, higher salaries, more work-life balance, work from home options or change industries altogether, it’s imperative that the industry quickly identifies solutions to address the issue of understaffing. There may not be an immediate fix, but there are several solutions in place working to increase the talent pool for everyone in research. Many sites have already begun offering internships and training programs, working with universities, and looking beyond the industry to supplement staffing needs. However, higher budgets are needed to retain site staff, train new staff, subcontract, or partner with other sites to conduct trials. This means sponsors and CROs need to be more flexible with study budgets to account for these increased staffing needs, especially if new technology is involved in the study. More technologies are emerging in the industry and training is needed for each, which adds a considerable amount of time to workloads for already-busy site staff and increased personnel with special expertise that may better fit the changing landscape for sites. Staff Poaching Industry professionals switching organizations is unavoidable, especially with the limited pool of qualified staff. As many organizations search for candidates, they want to work with who they already know and have identified as highly qualified candidates. However, many sites in the SCRS Member Community have shared that sponsors and CROs soliciting site staff is creating an even greater strain on their operations. It’s not the first time SCRS has heard about the issue. One SCRS community member commented, “It’s a disservice to our industry as it potentiates a site’s need to increase their budgets/overhead to start to offer even remotely competitive packages. In most cases, it’s a disruption to their own projects so reminding them about these implications are important.” Ultimately, this tactic affects site operations significantly; medications may reach the market slower and patients will be impacted both in enrollment and continuity of care. There is also risk to ongoing projects quality when significant turnover is impacted at the site level.  Ensuring site sustainability is the mission of SCRS and we call on our partners to strongly reconsider this practice. How can sites, sponsors and CROs address understaffing and poaching? Sponsors & CROs: Non-solicitation clauses will become more common in site contract language and additional payouts may be due for site staff poaching. Payouts will go toward site staff recruitment, replacement and/or training. Some sites may escalate to sponsor or CRO if employee solicitation is occurring. Consider how this will affect your relationship with the site and sponsor. Be open to contract negotiations from sites regarding budgeting and staff needs which may include an increase in overhead. Avoid hiring practices/fairs in conferences such as SCRS Summits as this may impact sites sending their clinical research professionals. SCRS recommends not sending any HR personnel to industry events. Potentially work with sites in a more collaborative manner for growth development. Also, if there is a transition from site to sponsor or CRO, consider the time needed to transition. Practices of immediate departures should be discouraged.  Sites: Implement a non-solicitation in contracts and ensure it covers a reasonable timeframe. Note that non-solicitation clauses may require reciprocation from the CRO or may be difficult to enforce. Include an additional payout due by the CRO that will help your site to recruit and train new staff and request if poaching has occurred. What is your organization’s culture and communication like? Prioritize open feedback and see if there are any areas for improvement. What other competitive benefits can you offer employees aside from higher salaries? Offering remote opportunities or shift flexibility can also be enticing for employees to stay. Open staff recruitment outreach to emerging and diverse personnel who have the right educational background, core competencies, and certifications but may not have clinical experience.  Create an entry-level position that allows for growth into more senior roles. Consider a simplified but robust onboarding program to manage transitions; it is important to proactively plan and to be prepared.  If capable, continue with general HR postings for key positions and have candidates pre-identified especially if you feel there may be flight risk. Are there any systems or personnel that would create efficiencies, reduce administration and/or technology burden in the long-term for your site operations? Speak up about your staffing and budgeting needs to sponsors and CROs. Share feedback about the amount of time it takes to implement new tech and costs associated with staff training, implementation, maintenance, IT infrastructure or storage requirements, etc.

Decentralized Trials & Subcontracting: What Sites Need to Look Out For

Changes brought on by the pandemic have encouraged the industry to adapt quickly, especially when it comes to adoption of new technologies. Many sites pivoted to hybrid decentralized trials, meaning some patient visits were conducted virtually instead of on-site. However, some sites have still expressed hesitation with decentralized visits for various reasons. In the SCRS Member Community, sites discussed subcontracting concerns as one reason for declining decentralized trial opportunities.  One site shared, “We have been approached about participating in a decentralized trial.  We think it may be good to get some experience in such a trial since there seems to be an interest by sponsors in moving in this direction.   Recruiting and many of the visits will be done remotely by another agency the sponsor contracts with. We have been asked to sign a delegation log listing the third-party company on the delegation log, not the specific personnel.  We do not know the staff who will be working on their behalf.  The staff may be in several different states. This makes us a little nervous as our PI is supposed to be responsible for the conduct of the trial and we really do not know the qualifications of any of the people working for this third party. Is this usual and customary?”  This language is not necessarily common, but some CROs may do it more than others. Sites, understandably, are apprehensive to agree to these terms. Many have declined studies because of this language alone.   To clarify, the CRO is responsible for the behavior of its vendors chosen – not the site. This should be stated in the CTA as an indemnification of the site. Additionally, CROs should allow sites the authority to change the vendor or people they work with at the vendor organization as needed.  If the site agrees to this liability, they should have a say in who they work with. Additionally, sites should validate any vendors’ business insurance to limit their liability if they plan to sign a contract with this language.  SCRS Honorary President David Vulcano shared, “I have had conversations with FDA on this via an ACRP Fellows task force, and they don’t like it when the Sponsor/CRO picks the personnel and do not give the investigator any control. It’s fine for them to pay directly for the service, but unless the home visits are set up as a different site under a different PI (i.e. two site/PIs handing the subjects back and forth), you and your PI must be In control.”  If this language is included in your CTA, SCRS encourages sites to have a further conversation with the CRO. Liability should not be solely on the site, and at a minimum there needs to be indemnification language to ensure minimal liability for the site on behalf of the other organization. Sponsors and CROs can be proactive in contracts to provide sites with options for who they would like to work with and reduce the burden of liability for things the site cannot control. The best option, however, would be to separate the two organizations altogether in the CTA. The FDA may release guidance on this topic in the near future, but we recommend sites communicate their needs and concerns to improve industry partnerships for all. 

SCRS Announces Leadership Changes

Contact: SCRS Communications Society for Clinical Research Sites 410.696.5080 communications@myscrs.org FOR IMMEDIATE RELEASE SCRS Announces Leadership Changes Hanover, MD, May 12, 2020 – In the midst of the COVID-19 pandemic, clinical research has become more important than ever. The Society for Clinical Research Sites (SCRS) remains committed to its mission of site sustainability. To best address the current industry environment, SCRS has strategically realigned to focus on upcoming initiatives and overall member needs. In the course of this realignment, Casey Orvin, President of SCRS, has agreed to transition into an advisory role as Honorary President.  During this time, Orvin is taking another role within the industry that will allow him to continue to support SCRS’ mission as well as clinical research sites and patients. SCRS’ core executive team remains in place, staying true to its mission of unifying the voice of the global clinical research site community. Allyson Small, Chief Operating Officer, continues to lead the executive team on all programs. Small commented: “SCRS remains committed to site sustainability. The organization deeply appreciates the continued support of our Global Impact Partners and the global clinical research site community. SCRS is confident that the resilient site community will continue to persevere and lead through these trying times.” ### About SCRS Founded in 2012, SCRS is a global organization that unifies the voice of the clinical research site community to create greater site sustainability. Representing over 9,500 sites in 47 countries, SCRS membership provides sites with a community dedicated to advocacy, education, mentorship and connectivity. SCRS is an influential voice for sites and an active partner in industry-wide initiatives and dialogues focused on improving the clinical research enterprise. Our Voice. Our Community. Your Success. Join the community. Visit myscrs-new.local/.

SCRS Calls on Sponsors to Release Holdback Funds in Response to COVID-19

Contact: Jessica Knott Sr. Communications Manager Society for Clinical Research Sites 410.696.5080 x120 jessica.knott@myscrs.org FOR IMMEDIATE RELEASE SCRS Calls on Sponsors to Release Holdback Funds in Response to COVID-19 Hanover, MD, April 2, 2020 – COVID-19 has left sites experiencing significant financial strain as enrollment into many trials, as well as monitoring visits to review data and generate milestone payments have been halted. With 59% of sites in 2019 reporting that they have only three months or less of operating cash, this financial loss is having a considerable impact on their ability to keep their doors open and continue life-saving work. In the midst of the COVID-19 pandemic, SCRS calls on sponsors to release site payment holdback funds in an effort to help sites remain sustainable.  “Sponsors and other industry partners often ask SCRS how they can better support sites,” said SCRS President Casey Orvin. “SCRS’ Site Landscape survey data show that although 55% of sites attempt to negotiate their withholding amount for every study, only 11% are successful. SCRS has consistently fought for better site payment terms since our inception, such as monthly payments, and progress has been made. However, we are not there yet. Now is the time to release holdback funds so that sites can continue their work to save lives.” SCRS has recently spoken to several small, mid and large-sized pharmaceutical organizations to advocate for the release of holdback funds during this crucial time. A majority have been responsive, indicating that they are open to the idea and are considering lowering withholding amounts or eliminating the practice altogether moving forward. SCRS is also aware that several organizations ended the practice of withholding years ago. For sponsors that are still negotiating, we encourage you to move forward as quickly as possible. “Working together,” Orvin said, “we are confident that as an industry we will continue to accomplish great things, including developing a vaccine and treatments for COVID-19.” ### About SCRS Founded in 2012, SCRS is a global organization that unifies the voice of the clinical research site community to create greater site sustainability. Representing over 9,500 sites in 47 countries, SCRS membership provides sites with a community dedicated to advocacy, education, mentorship and connectivity. SCRS is an influential voice for sites and an active partner in industry-wide initiatives and dialogues focused on improving the clinical research enterprise. Our Voice. Our Community. Your Success. Join the community. Visit myscrs-new.local/.

SCRS Welcomes Deep Lens to the Global Impact Partner Program

Contact: Jessica Knott Sr. Communications Manager Society for Clinical Research Sites 410.696.5080 x120 jessica.knott@myscrs.org FOR IMMEDIATE RELEASE SCRS Welcomes Deep Lens to the Global Impact Partner Program Hanover, MD, March 31, 2020 – The Society for Clinical Research Sites (SCRS) announced today that Deep Lens has joined the organization as a Global Impact Partner (GIP). SCRS’ GIP Program provides a unique opportunity for sponsors, CROs and solution providers to engage with SCRS and its members in an impactful manner. Becoming a GIP demonstrates Deep Lens’ commitment to clinical research sites, their desire to develop a deeper understanding of the needs of sites and contribute to the development and implementation of solutions in the marketplace. “We are extremely excited to be a new SCRS Global Impact Partner and to contribute through the GIP program,” said Deep Lens CEO & Co-founder Dave Billiter. “Deep Lens looks forward to learning from SCRS’ talented site members and contributing to optimize and grow clinical research by matching the right patient with the right trial at the right time. SCRS provides the platform to discuss and address current challenges, problem-solve as a larger group, and showcase innovation. Being a part of the GIP program will elevate our awareness, increase our knowledge, and enable Deep Lens to broaden our communication and collaborations.” “Deep Lens is doing important work to connect patients with suitable clinical trials at the time of diagnosis,” said SCRS President Casey Orvin, “which provides needed support to clinical research sites as they recruit patients into their trials. SCRS looks forward to incorporating Deep Lens’ contribution and insight to support our global member site community. We are thrilled to welcome Deep Lens to the Global Impact Partner (GIP) program.” ### About Deep Lens Deep Lens is a software company focused on a groundbreaking approach to faster recruitment of the best-suited cancer patients to clinical trials. By identifying patients at the time of diagnosis and combining lab, EMR and genomic data, VIPER, Deep Lens’ integrated cloud platform, provides care teams with visibility and workflows to accelerate recruitment and compress study timelines to bring game-changing therapies to market sooner. Growing with sponsors, providers and strategic partners, Deep Lens challenges the status quo so that patients can get the therapies they want and deserve. deeplens.ai About SCRS Founded in 2012, SCRS is a global organization that unifies the voice of the clinical research site community to create greater site sustainability. Representing over 9,500 sites in 47 countries, SCRS membership provides sites with a community dedicated to advocacy, education, mentorship and connectivity. SCRS is an influential voice for sites and an active partner in industry-wide initiatives and dialogues focused on improving the clinical research enterprise. Our Voice. Our Community. Your Success. Join the community. Visit myscrs-new.local/.

SCRS European Summit Rescheduled Due to COVID-19

Contact: Jessica Knott Sr. Communications Manager Society for Clinical Research Sites 410.696.5080 x120 jessica.knott@myscrs.org FOR IMMEDIATE RELEASE SCRS European Summit Rescheduled Due to COVID-19 Hanover, MD, March 4, 2020 – The Society for Clinical Research Sites (SCRS) has announced that its European Site Solutions Summit, originally scheduled to be held 9-10 March 2020, has been rescheduled due to COVID-19 to 16-17 November 2020. SCRS has received a number of concerned messages regarding the Coronavirus/COVID-19 from European Summit attendees. While Portugal has no current travel restrictions, many global organizations are reducing or cancelling all international travel for the immediate future. As national and global efforts to contain the virus are underway, the most recent notices are impacting attendees, speakers and several exhibitors.   For these reasons, and to ensure the safety of our community, SCRS has altered the dates for the 2020 European Site Solutions Summit to 16-17 November 2020. If you are registered to attend the European Summit and have not received an email with further information, please contact summits@myscrs.org.  We understand that this is an unfortunate situation, with new policies and implications developing globally. This program alteration comes from a genuine desire to ensure that the SCRS community stays healthy and safe. Just as important, we want to ensure that your support and investment in the Summit is as valuable as possible.  SCRS is committed to delivering engaging and educational content to all Summit attendees, including our member sites and corporate partners. By rescheduling the European Summit we believe our mission of site sustainability will be better achieved, as more organizations will be able to attend and participate in the meaningful dialogue that helps pave the way for innovation in clinical research each year. SCRS will continue to monitor all aspects of the potential impact to our community and respond accordingly.   For more information, visit www.EUSiteSolutionsSummit.com. ### About SCRS Founded in 2012, SCRS is a global organization that unifies the voice of the clinical research site community to create greater site sustainability. Representing over 9,500 sites in 47 countries, SCRS membership provides sites with a community dedicated to advocacy, education, mentorship and connectivity. SCRS is an influential voice for sites and an active partner in industry-wide initiatives and dialogues focused on improving the clinical research enterprise. Our Voice. Our Community. Your Success. Join the community. Visit myscrs-new.local/.

SCRS Announces Promotion of Allyson Small to Chief Operating Officer

Contact: Jessica Knott Sr. Communications Manager Society for Clinical Research Sites 410.696.5080 x120 jessica.knott@myscrs.org FOR IMMEDIATE RELEASE SCRS Announces Promotion of Allyson Small to Chief Operating Officer Hanover, MD, January 14, 2020 – The Society for Clinical Research Sites (SCRS) announced today that VP of Operations, Allyson Small, has been promoted to Chief Operating Officer (COO). Ms. Small joined the SCRS team in 2013 and has served the organization through a variety of roles, including planning four SCRS Summits annually. When SCRS founder Christine Pierre fell ill in early 2017, Ms. Small single-handedly managed the day-to-day operations of all SCRS events and staff. “I have believed in SCRS’ mission and commitment to the global site community since I joined the team in 2013,” said Allyson Small. “The work we do is deeply needed, and I find SCRS’ contribution to the growth and unification of the clinical research industry very exciting. I look forward to continuing to work closely with our member sites and industry partners in this new role, and am excited for what 2020 holds.” “I am thrilled to have the opportunity to work with Allyson in this newly appointed and much-deserved role,” said SCRS President, Casey Orvin. “Allyson has consistently stepped in wherever needed to support SCRS when it was needed most, and has played an integral role in the company’s growth since its inception. I am confident that SCRS will continue to grow and expand under Allyson’s guidance as COO.” ### About SCRS Founded in 2012, SCRS is a global organization that unifies the voice of the clinical research site community to create greater site sustainability. Representing over 9,500 sites in 47 countries, SCRS membership provides sites with a community dedicated to advocacy, education, mentorship and connectivity. SCRS is an influential voice for sites and an active partner in industry-wide initiatives and dialogues focused on improving the clinical research enterprise. Our Voice. Our Community. Your Success. Join the community. Visit myscrs-new.local/.

Medidata Becomes Funding Sponsor of SCRS Diversity Program

Contact: Jessica Knott Sr. Communications Manager Society for Clinical Research Sites 410.696.5080 x120 jessica.knott@myscrs.org FOR IMMEDIATE RELEASE Medidata Becomes Funding Sponsor of SCRS Diversity Program Hanover, MD, December 18, 2019 – The Society for Clinical Research Sites (SCRS) announced today that Site Engagement Partner, Medidata Solutions, made a commitment to become a funding sponsor of the SCRS Diversity Program, Site Awareness and Best Practices for Inclusion of Diverse Populations in Research. The program is aimed at developing a better understanding of the knowledge, expertise and best practices required for clinical research sites to meet the needs of an increasingly diverse population, and to provide knowledge and solutions to aide sites in more successfully including diverse populations in clinical research. “Medidata’s partnership with SCRS continues to be invaluable, and the connection with their member sites and Global Impact Partner organizations continues to influence our products,” said Jackie Kent, EVP, Head of Product, Medidata. “Supporting SCRS’ Diversity in Clinical Trials Program allows us to continue to grow our relationship and participate with other industry leaders in driving solutions to this very important topic. At Medidata we believe that all patients should have access to treatment, and as a result we have deepened our focus on and commitment to diversity in clinical trials. Medidata is able to help address the diversity challenge by using our data, solutions and technology to broaden the ability for more patients to participate in clinical trials. We are thrilled to be a part of the SCRS Diversity Program and look forward to our continued collaboration.” “Medidata has been involved in a number of innovative projects related to bringing the perspective of clinical research sites into the forefront of discussions,” said Diana Foster, SCRS VP of Strategy and Special Projects. “Their engagement with the SCRS diversity program further illustrates the company’s forward thinking on behalf of sites around the world. We look forward to folding their diversity experience into our project team.” ### About SCRS Founded in 2012, SCRS is a global organization that unifies the voice of the clinical research site community to create greater site sustainability. Representing over 9,500 sites in 47 countries, SCRS membership provides sites with a community dedicated to advocacy, education, mentorship and connectivity. SCRS is an influential voice for sites and an active partner in industry-wide initiatives and dialogues focused on improving the clinical research enterprise. Our Voice. Our Community. Your Success. Join the community. Visit myscrs-new.local/. About Medidata Medidata is leading the digital transformation of life sciences, creating hope for millions of patients. Medidata helps generate the evidence and insights to help pharmaceutical, biotech, medical device and diagnostics companies, and academic researchers accelerate value, minimize risk, and optimize outcomes. More than one million registered users across 1,400 customers and partners access the world’s most-used platform for clinical development, commercial, and real-world data. Medidata, a Dassault Systèmes company (Euronext Paris: #13065, DSY.PA), is headquartered in New York City and has offices around the world to meet the needs of its customers. Discover more at www.medidata.com and follow us @Medidata, The Operating System for Life SciencesTM. Medidata is a registered trademark of Medidata Solutions, Inc., a wholly owned subsidiary of Dassault Systèmes.

VirTrial Becomes Funding Sponsor of SCRS Diversity Program

Contact: Jessica Knott Sr. Communications Manager Society for Clinical Research Sites 410.696.5080 x120 jessica.knott@myscrs.org FOR IMMEDIATE RELEASE VirTrial Becomes Funding Sponsor of SCRS Diversity Program Hanover, MD, December 3, 2019 – The Society for Clinical Research Sites (SCRS) announced today that Circle of Sustainability Partner, VirTrial, has made a commitment to become a funding sponsor of the SCRS Diversity Program, Site Awareness and Best Practices for Inclusion of Diverse Populations in Research. The program is aimed at developing a better understanding of the knowledge, expertise and best practices required for clinical research sites to meet the needs of an increasingly diverse population, and to provide knowledge and solutions to aide sites in more successfully including diverse populations in clinical research. “VirTrial understands the importance of diversity in clinical trials, and believes that increasing access for patients is a fundamental element to forward movement,” said VirTrial VP of Business Development, Amanda Rangel. “Introducing virtual visits will allow sites to reach a wider demographic and extend access to clinical trials to underrepresented populations. We look forward to collaborating with SCRS on this important initiative.” “The addition of VirTrial to the SCRS Diversity Program provides an opportunity to include a new perspective related to approaching diverse populations,” said VP of Strategy and Special Projects, Diana Foster. “The recent HHS guidance speaks to considering methodology in reaching diverse populations, which SCRS will be able to explore more fully with Virtrial’s involvement.” ### About VirTrial VirTrial is a technology company using a stable, long-standing telehealth platform to transform the clinical trials industry. The platform offers a Virtual Care Management (VCM) program that combines video, text, and email allowing pharmaceutical companies and CROs to create patient-centric trials by replacing some study visits with virtual visits. The vision is for 25-50% of the visits to be conducted virtually creating a hybrid model. This model is ideally suited for Phase III/Phase IV trials where patient compliance can be assessed from any location. Our Virtual Care Management (VCM) program allows sites to review and assess patient compliance. The VirTrial app is supported on any device (Apple, Android, tablet and/or computer) and can be used by any site. It is hosted in a secure, cloud-based, environment and is HIPAA compliant. VirTrial enables greater accessibility to trials for patients, higher performance by clinical trial sites, and improved outcomes for pharmaceutical companies. Working together we can bring better medications to market more quickly. To learn more about VirTrial, visit https://www.virtrial.com. About SCRS Founded in 2012, SCRS is a global organization that unifies the voice of the clinical research site community to create greater site sustainability. Representing over 9,500 sites in 47 countries, SCRS membership provides sites with a community dedicated to advocacy, education, mentorship and connectivity. SCRS is an influential voice for sites and an active partner in industry-wide initiatives and dialogues focused on improving the clinical research enterprise. Our Voice. Our Community. Your Success. Join the community. Visit myscrs-new.local/

SCRS Now Accepting Submissions for Site Patient Enrollment Innovation Award (SPRIA℠) at the 2020 European Site Solutions Summit

Contact: Jessica Knott Sr. Communications Manager Society for Clinical Research Sites 410.696.5080 x120 jessica.knott@myscrs.org FOR IMMEDIATE RELEASE SCRS Now Accepting Submissions for Site Patient Recruitment Innovation Award (SPRIA℠) at the 2020 European Site Solutions Summit Hanover, MD, November 25, 2019 – The Society for Clinical Research Sites (SCRS) announced today that submissions are now being accepted for the Site Patient Recruitment Innovation Award (SPRIA℠) at the European Site Solutions Summit 9-10 March, 2020. Launched in 2014 at the Global Site Solutions Summit, past and present SPRIA winners are recognized throughout the global clinical research industry as leading sites in patient recruitment. SPRIA Europe nominees will be comprised of sites that place emphasis on innovative, patient-directed programs that are unique and effective. Key elements of success will include adhering to study timelines, innovation in execution of a recruitment plan, and achieving enrollment goals. European sites are invited to begin submitting their innovative recruitment plan for SPRIA Europe consideration. An independent judging panel will select three finalists from the submissions. The finalists will present their plans to the attendees of the 5th annual European Site Solutions Summit in Lisbon, Portugal, and the winner will be announced at the conclusion of the Summit. Sites can submit their recruitment plans for SPRIA Europe consideration here. The European Site Solutions Summit is a two-day event uniquely focused on sites. Sites, sponsor/CRO executives, and other industry stakeholders will gather to share best practices for site sustainability. Learn more about SPRIA Europe, and join us for the European Site Solutions Summit! Register today. ### About SCRS Founded in 2012, SCRS is a global organization that unifies the voice of the clinical research site community to create greater site sustainability. Representing over 9,500 sites in 47 countries, SCRS membership provides sites with a community dedicated to advocacy, education, mentorship and connectivity. SCRS is an influential voice for sites and an active partner in industry-wide initiatives and dialogues focused on improving the clinical research enterprise. Our Voice. Our Community. Your Success. Join the community. Visit myscrs-new.local/.

Parexel Becomes SCRS Site Engagement Partner with Contribution to SCRS Diversity Program

Contact: Jessica Knott Sr. Communications Manager Society for Clinical Research Sites 410.696.5080 x120 jessica.knott@myscrs.org FOR IMMEDIATE RELEASE Parexel Becomes SCRS Site Engagement Partner with Contribution to SCRS Diversity Program Hanover, MD, October 31, 2019 – The Society for Clinical Research Sites (SCRS) announced today that Global Impact Partner (GIP), Parexel, has made a commitment to become a funding sponsor of the SCRS Diversity Program, Site Awareness and Best Practices for Inclusion of Diverse Populations in Research. The program is aimed at developing a better understanding of the knowledge, expertise and best practices required for clinical research sites to meet the needs of an increasingly diverse population, and to provide knowledge and solutions to aide sites in more successfully including diverse populations in clinical research. Parexel’s contribution to the SCRS Diversity Program has aligned the organization as a Site Engagement Partner, further demonstrating their commitment to clinical research sites and their desire to develop a deeper understanding of the needs of sites and contribute to the development and implementation of solutions in the marketplace. “Parexel understands the importance of diversity in clinical trials and we believe that effective engagement with sites is key to driving progress forward in this regard,” said Gadi Saarony, executive vice president and chief clinical research services officer, Parexel. “SCRS shares our commitment and we look forward to collaborating on key initiatives that will ultimately improve drug development experience for patients.” Diana Foster, PhD, VP of strategy and special projects for SCRS commented, “Parexel’s decision to support the SCRS Diversity Program marks the first CRO to step forward and join the group as a sponsor of this important work. The program has been supported for three years by industry and is providing cutting edge-initiatives to help guide sites in becoming educated and proactive in enrolling diverse patients in clinical trials. We look forward to the perspective of the Parexel leadership team.” ### About Parexel Parexel is focused on supporting the development of innovative new therapies to improve patient health. We do this through a suite of services that help life science and biopharmaceutical customers across the globe transform scientific discoveries into new treatments for patients. From clinical trials to regulatory and consulting services to commercial and market access, our therapeutic, technical and functional ability is underpinned by a deep conviction in what we do. For more information, visit our website and follow us on LinkedIn, Twitter and Instagram. Parexel is a registered trademark of Parexel International Corporation. All other trademarks are the property of their respective owners. About SCRS Founded in 2012, SCRS is a global organization that unifies the voice of the clinical research site community to create greater site sustainability. Representing over 9,500 sites in 47 countries, SCRS membership provides sites with a community dedicated to advocacy, education, mentorship and connectivity. SCRS is an influential voice for sites and an active partner in industry-wide initiatives and dialogues focused on improving the clinical research enterprise. Our Voice. Our Community. Your Success. Join the community. Visit myscrs-new.local/.