Society for Clinical Research Sites (SCRS)

The FDA has published a guidance for the use, design, and conduct of trials with decentralized elements. A great deal of key learnings and take-aways here. My takeaways from this article: 1. Nothing ground breaking or alternative as it pertains to definitions, conduct, design, or benefits. 2. They specifically cite incorporating patient input as a must-have. I agree completely. 3. Local HCP's can conduct trial activities like physicals, but anything beyond "routine clinical practice" is the responsibility of trial personnel. 4. Responsibilities of the Sponsor: oversight of activities, including using networks of local HCPs, Data management and collection plan, and a trial design that reflects the intended patient population. 5. Responsibilities of the Investigator: Oversight of participant rights and accuracy of data, appropriate delegation based on local HCP capability. 6. Investigators and sites - pay special attention to page 8 - 11! What I think is interesting here is only those that "contribute directly and significantly to the trial data" need be listed on 1572 as Sub-I's. Yet, "investigators do not need to maintain a log of local HCPs performing trial-related activities." But that doesn't mean they aren't appropriately delegated duties. It's still made clear that its the investigator's responsibility to ensure trial related activities delegated are conducted appropriately. I KNOW this is a source of confusion for sites. 7. Nothing exciting pertaining to remote informed consent, FDA's role, or IRBs 8. A few good reminders about IP, Shipping, and Safety to consider in this new model. I hope every site and sponsor/CRO study manager will read this, and use it to help guide decisions and SOPs. Huge thank you to the FDA for prioritizing this work, and helping us move forward with using decentralized elements.

The latest InSite Journal is available now! In this issue, read insights from: + ProofPilot on trial participant data sharing + Greenphire on the importance of timely site payments + Remington-Davis, Inc. Clinical Research on strategies for accelerated patient recruitment + Labcorp on enhancing healthcare with electronic medical records and AI + SCRS West and meeting site needs with trial technology Explore InSite here ? https://lnkd.in/eaKwGiiR

SCRS is proud to announce a new partnership with AMR (Alliance for Multispecialty Research) as part of the SCRS Global Impact Partner (GIP) program. Founded in 1994 as an independent clinical research site network, AMR consolidated in 2017 and now operates as a fully integrated site organization. AMR is an award-winning leader in the clinical research field due to its dedication to excellence, custom-tailored project delivery and operational efficiencies. Read more about the partnership ? https://lnkd.in/e9J977Yv

SCRS is thrilled to welcome Mural Health to the Global Impact Partner program. Mural Health leads a variety of initiatives designed to enhance the clinical trial experience for patients and caregivers through empathy-centered innovation. Their participant management platform, Mural Link, offers advanced participant payments, travel and concierge services, site and participant communication, and reporting. Read more about the announcement ?https://lnkd.in/exhMtsUS

Hybrid clinical trials have significant opportunities to improve patient accessibility and diversity within clinical trials. This webinar will analyze how technology can help streamline site operations, centralize trial data, and provide real-time data access and management. Register here ? https://lnkd.in/eRtZyYsg

Renuka Agarwal, CEO and co-founder of UpTrials, is revolutionizing site workforce challenges. Renuka shares the inspiration behind founding UpTrials, and how the platform is making a significant impact by matching research sites with skilled candidates. Learn how UpTrials is streamlining the hiring process, improving time-to-fill rates, and bringing much-needed innovation to clinical research hiring processes ? https://lnkd.in/eSN_CZah

Welcome Lightship to the SCRS Global Impact Partner Program! Lightship designs and delivers clinical trials that are more accessible and offer more choices to patients in need. By working together we can bring better therapies to people faster. In designing and conducting clinical trials with sponsors and partners, they keep people at the heart of our approach.

The SCRS Payment Initiative is committed to addressing financial burdens for research sites and study participants. The program aims to mitigate various financial challenges within clinical research such as holdbacks, tax on participant payments, and delayed site payment frequencies. Explore resources for industry partners to address current site and trial participant payment challenges ? https://lnkd.in/esYwqf8i

Join us in welcoming CRIO to the Global Impact Partner program! "At CRIO, we've always believed in the critical role that clinical trial sites play in advancing medical research, which is why we're thrilled to join the SCRS Global Impact Partnership Program," said Raymond Nomizu, CRIO Founder and co-CEO. "Both CRIO and SCRS are deeply committed to empowering and supporting the success of clinical trial sites. Through this partnership, we look forward to combining our expertise and resources to further enhance the capabilities of research sites and ultimately accelerate the development of life-changing treatments."

SCRS is so excited to welcome Lauren Stockwell to our team! As Content and Engagement Manager, Lauren will be overseeing Summit speaker placement, developing site-focused educational content, and supporting our upcoming site mentorship program. She has been an incredible advocate for SCRS and the site community, with true alignment with our mission. Welcome aboard, Lauren —we're so glad to have you!