Site Management/Investigator Payments Featured Articles
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4 Ways Academic Medical Centers Can Capture Greater Value In The Cell & Gene Therapy Industry
8/22/2023
Academic medical centers (AMCs) are unique in the way academic functions and healthcare delivery services are co-located. With strong research capabilities, access to leading scientists, access to patients, and more, AMCs are uniquely positioned to conduct research and clinical trials, enable process development and manufacturing, and more.
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Why Sponsor Awareness Cannot Be "Day Zero" For SUSAR Reporting
8/16/2023
Part 1 of this article explained that the FDA’s goal is to ensure safety not to provide a compliance safety net to sponsors by enabling arbitrary rules around SUSAR reporting timelines. A few readers raised points to justify using sponsor awareness as Day Zero for SUSAR reporting, regardless of when the PI becomes aware. Part 2 addresses those points and why they miss the mark.
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Implementing New Technology: Is Change Always Good?
8/9/2023
New clinical trial technologies promise increased ROI but gaining buy-in from sites and staff, managing the transition, and anticipating the next big leap in technology present many challenges.
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A Shift Toward Trial Site Management Organizations: Trends And Implications For Sponsors
8/9/2023
Site management organizations account for 10-20% of total clinical trial patient volume, but they're use among sponsors is on the rise. Explore key trends shaping the SMO landscape and value proposition, what implications these trends have for trial sponsors, and how sponsors can adapt to these evolving conditions.
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How CRAs Can Develop Better Relationships With CRCs
7/14/2023
Understanding how pandemic-era changes to the clinical site monitoring paradigm have stressed relationships between CRCs and CRAs, it’s time to consider ideas on how this critical yet tenuous relationship can be improved with clear expectations, thoughtful requests, and kindness.
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How Sponsors Can Help Clinical Sites Recruit & Retain Staff — And Why They Should
7/3/2023
Recruitment and retention of site staff are more challenging today than ever before. Society for Clinical Research Sites (SCRS) Vice President of Site Engagement Jimmy Bechtel presents his top ways sponsors and sites can work together in hiring — and keeping — well-trained and satisfied site staff.
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Q&A About Bristol Myers Squibb’s Consolidated Site Payments Strategy
6/27/2023
How do payment systems affect site-sponsor relationships? George Kourtsounis of Bristol Myers Squibb and Casey Orvin of CenExel Clinical Research lend their expertise to this question and more.
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Becoming A PI: The Power of Physician-To-Physician Recruitment
5/25/2023
Principal investigators (PI) can be in short supply. So, what's the best way to encourage more physicians to become PIs? By enlisting the help of other physicians. Here, Dr. Katie Smentek shares her experience of becoming her clinic's first PI and how she encourages fellow doctors to become investigators in clinical trials.
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How Sites Are Managing The Rising Costs Of DCTs
5/23/2023
How do DCTs affect site costs? Clinical Leader asked experts to share their thoughts on the rising costs and staffing challenges brought on by the proliferation of DCTs.
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Why Clinical Site Awareness Should Be "Day Zero" For SUSAR Reporting
5/3/2023
Ask a handful of clinical research professional about the determination of "Day Zero" when reporting a suspected, unexpected, serious adverse reaction (SUSAR), and you may get a variety of answers. While sponsors are ultimately responsible for SUSAR reporting adherence, Penelope Przekop contends that clinical sites should be the ones that start the clock when it comes to meeting regulatory timelines.