No one is saying that clinical trial sites, sponsors, and contract research organizations (CROs) can’t symbolically gather ’round the campfire and get along with one another. In fact, they can and must, if the clinical research enterprise is to keep running on all cylinders. But if the relationship can be compared to that between cousins, it matters a great deal if we’re talking about the cousins whom you see often and get along with well enough to essentially be your siblings, or the cousins whom you have trouble remembering much about when they show up at the occasional reunion.
So it is that, in the forthcoming August issue of ACRP’s Clinical Researcher journal, we consider the theme of “Better Together: Getting Sites, Sponsors, and CROs All on the Same Page” by way of a variety of contributors who address the nuances of these potentially rewarding and potentially fraught ties between research partners.
In her Special Feature on “Death by a Thousand Portals: Addressing Technology Fragmentation and Site Burden in Clinical Research,” Tejashree Kulkarni, MS, examines technology fragmentation from a research site perspective and argues that the primary challenge is not digitalization itself, but the lack of integration and standardization across the clinical research ecosystem. “Reducing unnecessary administrative burden will require greater interoperability, standardized access management, reduced duplication, and the inclusion of technology burden in study start-up and feasibility planning,” she writes. “The challenge is not technology itself; the challenge is that each stakeholder often selects systems based primarily on its own operational requirements. Sponsors may select systems that support sponsor oversight. CROs may use systems that support centralized trial management. Vendors may provide platforms optimized for specific services. Sites, however, must operate across all of these systems simultaneously. The site therefore experiences the cumulative effect of decisions made by multiple stakeholders.”
Further, in their column on “Why Capable Research Sites are Still Being Overlooked in Clinical Trials,” Denise McNerney and Chris Matheus focus on how clinical research sites play a central role in the successful execution of clinical trials, yet many capable and experienced sites remain underutilized. “Despite strong investigator experience and operational infrastructure, sites often encounter barriers related to visibility, feasibility alignment, and fragmented communication across the clinical research ecosystem,” they write. “Strengthening alignment across sponsors, CROs, and research sites is essential to improving trial performance and sustainability.” The authors go on to consider the structural and operational factors that limit site participation in clinical trials, outlining common breakdowns in feasibility and site selection processes, exploring the increasing operational pressures facing site teams, and highlighting practical strategies to improve site readiness and positioning.
Meanwhile, in his column on “What Clinical Trial Sites Should Know About Insurance and Indemnification Before Signing a Sponsor Agreement,” Tyler Cobb notes that insurance and indemnification provisions in Clinical Trial Agreements or Master Services Agreements between sites and sponsors answer one question: who pays when something goes wrong. “Under Good Clinical Practice standards, sponsors are generally expected to provide insurance or to indemnify the investigator and institution against claims arising from the trial, except for claims that arise from malpractice or negligence,” he writes. “That exception is where site exposure lives. If a claim is framed as a deviation from the protocol, a coordinator error, or negligent conduct of the study, the sponsor’s indemnity may narrow or disappear, and the site is left looking to its own contractual protections and its own insurance policies.” The common misconception, he adds, is treating a strong sponsor indemnity as a substitute for the site’s own coverage.
And in their peer-reviewed article on “Navigating Protocol Amendments: Understanding the Growing Burden and Charting a Path Forward,” Trevor Cole, BHS, MBA-HCM-PM, PMP, RN, CCRC, and Jessica Thurmond look at how protocol amendments have evolved from an expected operational reality to a defining factor in clinical trial performance, cost, and site sustainability. “Across sponsor, CRO, and site stakeholders, a consistent message is emerging: while amendments are often necessary, their frequency, timing, and execution are introducing significant downstream inefficiencies,” they write. “The evidence is clear: protocol amendments are now a system-level challenge requiring coordinated, industry-wide solutions.” The authors describe how the path forward is not eliminating amendments—it is engineering resilience into the amendment process through standardization, transparency, synchronization, and data-driven governance.
The August issue of Clinical Researcher will also include:
- Peer-reviewed articles on “Bridging the Monitoring Gap: A Structured Framework for Clinical Quality Management” by Inge Behroozfard Daraeikia, MPH, Kristi Prather, MPH, Elizabeth Bennett, Ashley Heath, Monica Lemmon, MD, Lindsey Spangler, JD, and Geeta Swamy, MD; “From Policy to Practice: How the World is Supporting Pediatric Research” by Tasha Mohseni; and “Envisioning eConsent Success (Part I): Measuring Operational Impacts at Clinical Trial Sites” and “Envisioning eConsent Success (Part II): Laying Out a Global Interoperability Blueprint for eConsent” by Amanda Zenere, Amber N. Hood, DFS, MS, CPIA, CIP, Candida Barlow, PhD, MSN, CRN-BC, RN, Catherine Gregor, MBA, CCRP, CCRC, Istvan Feteke, Kamila A. Novak, MSc, Katherine Leibowitz, JD, Megan Solomon, LPN, Spencer Phelps, and Andrea Bastek, PhD.
- A column on “Real-Time Clinical Trials Need More Than New Technology—They Need a New Operating Model” by Alison Holland.
- A Letter to the Editor on “Modifying Eligibility Criteria to Promote Female Participant Inclusion in Research” by Hannah J. Schmit, BA, Eric Garshick, MD, Vincent S. Fan, MD, Farrah Kheradmand, MD, Demerise Johnston, and Christine H. Wendt, MD.
Edited by Gary Cramer
