Setting all the glib metaphors about mixing cats and dogs or oil and water aside, it seems safe to say that everyone in the clinical research enterprise recognizes the serious need for study sites and sponsors/contract research organizations (CROs) to rise above their differences and get along for the sake of making medical advancements through clinical trials. But even with decades of practice at trying to maintain balance in such delicate relationships on an industrywide scale, lessons remain to be learned by stakeholders on both sides.
No surprise, then, that at the recent ACRP 2026 gathering in Orlando, more than a few presentations focused on the whys and how-tos of bringing study teams together from across the divisions that can threaten the stability of everything from new (and perhaps risky) ventures to even the most seemingly solid of projects and long-term partnerships.
For example, in their session on “Cultivating Key Relationships for Optimized Collaboration Between Sponsors, Sites, and Participants,” Doris Chang and Summer Borsack, both Associate Clinical Research Associates with Merck & Co., Inc., noted that, despite everyone’s best intentions, misaligned expectations and communication friction can quietly cost weeks on timelines, inflate budgets, and erode participant trust. “What’s often missing is an effort—it’s a shared context,” said Borsack. “So here’s the opportunity: professionals who have sat on both sides—site and sponsor—often carry a ‘decoder ring.’ They can translate pressures, priorities, and practical realities in both directions. When we use that lens, we stop negotiating tasks and start co-designing outcomes.”
Looking into some of the common issues that arise between sites and sponsor/CROs, the duo discussed operational misfits and increasing complexity of protocols, communication gaps, misaligned incentives, technology friction, staff turnover, training gaps, varying experience levels across team members, vendor fragmentation, maintaining inspection readiness, competing trials, and study start-up bottlenecks. The good news is that “dual-experience individuals are uniquely positioned to make a disproportionate impact in closing the gap between sites and sponsors in clinical research,” Chang said. “These are individuals who have worked both at sites and at sponsors or CROs. They have sat in investigator meetings and governance meetings. They’ve managed patients in busy clinics and managed timelines in complex, cross-functional teams. Because of that, they can see both sides clearly and help align them.”
Meanwhile, in “Stronger Together: Leveraging Site-CRO Synergy for Better Research Outcomes,” Elizabeth Feathers, ACRP-CP, a Study Start-Up Supervisor in Clinical Operations, and Kassandra Nealon, ACRP-CP, a Manager in Clinical Operations, both with the National Marrow Donor Program (NMDP), a nonprofit organization focused on cell therapy, spoke from NMDP’s perspective as both a sponsor of its own studies and as a CRO helping manage studies on behalf of industry partners and investigators. “The idea that stronger site-CRO collaboration improves outcomes isn’t revolutionary, but achieving that collaboration consistently across sites and across organizations is much easier said than done,” Nealon said. Pointing to findings that only about one-third of sites report positive relationships with sponsors and CROs, she added, “more than half report dissatisfaction with CRO communication, and many view these partnerships as complicated rather than collaborative. These numbers right here make it clear while our industry is advancing scientifically, our operational relationships still need a lot of work.”
Outlining the kinds of challenges to effective partnerships that they see more often—including escalation pathways, timelines, resource constraints, process misalignment, and training gaps—the duo noted that, by closing the gaps and aligning on expectations upfront, they’ve reduced errors driven by uncertainty and improved confidence across their teams. Further, “Monitoring is sometimes perceived as an inspection rather than a collaboration, and when sites feel monitored at instead of supported by the CRO, openness naturally decreases,” Nealon said. “As a result, issues may go unreported or are surfaced later than they should be, which can impact patient safety, data quality, and our trust among this partnership. So our approach has been to deliberately reframe monitoring as a partnership focused on safety and data integrity. [Clinical research associates (CRAs)] are empowered to act as site advocates. Our CRAs invest time in understanding site workflows, recognizing site-specific nuances, and sharing best practices among their sites during and outside of monitoring visits. CRAs acknowledge what the sites are doing well, they provide targeted training, and they offer solutions rather than simply documenting findings. Equally important, the CRAs communicate site realities back to the CRO teams and study sponsors. They explain what’s working well, what is feasible and what isn’t, and most importantly, why.”
Monitors and those who are being monitored were also highlighted in a session on “Transforming Coordinator-Monitor Tensions into Clinical Trials Teamwork” delivered by a trio of speakers who have seen life from both sides of that fence as their careers have progressed: Jodie Addington, RN, CCRA, Senior Specialist; Misty Daniel, CCRC, CCRA, Senior Specialist; and Kelly Chan-Ojowu, CCRA, Manager, all situated in the Clinical Research Monitoring unit at Edwards Lifesciences. “The relationship between the coordinator and the monitor is something that has to be cultivated,” Addington said as she warmed their audience up to the topic. “It grows with communication, trust, and understanding. And depending on how we show up, it can either thrive or struggle.”
Professionals on both the site and sponsor sides need to appreciate that they have a common goal to be reached through monitoring sessions, the speakers noted—it’s to get the clinical trial across the line and the drug or device to market with reliable and verifiable data backing it up. Turning the attitudes of coordinators who are thinking, “Oh God, here comes this monitor—she’s going to list all these queries and find all these things that are wrong” away from an atmosphere of dread toward one of productive collaboration is what is going to prepare sites to thrive during the inevitable regulatory inspections and quality audits to come, they said.
The relationship between these partners in trials is also a financial one, and in their session on “From Silos to Synergy: Fixing Budget Friction Through Cross-Stakeholder Understanding,” Candida Barlow, PhD, MSN, CRN-BC, RN, Director of Clinical Research at the Oklahoma State University Center for Health Sciences; Andrea Bastek, PhD, Vice President of Market Strategy at Florence Healthcare; and Heidi Castle, CCA, Director of Business Development for Mercy Research, dove into the ramifications for clinical research of better mutual awareness of each other’s study budget negotiation pain points. Insights were shared from the activities of the Site Enablement League’s Budgets Working Group, a cross-industry initiative committed to improving clinical trial processes through collaboration, with an emphasis on best practices in budget justification and estimations tied to study procedure and hospital/clinic/lab costs (documented in a Research Chargemaster), administrative costs (overhead), and operational costs (including fixed costs documented on a Master Fee Schedule and staff and time effort supported by a Rate Card).
Various other topics in a Study & Site Management track were also in focus during sessions presented at the recent ACRP 2026 gathering in Orlando. A package of recorded sessions from this track is now available for purchase in the ACRP Course Catalog, as are packages for the full program of ACRP 2026 replays or smaller packages for the curated Clinical Operations, Innovation & Change Management, Regulatory & Quality, and Workforce & Professional Development tracks. Conference attendees already have access to all recorded ACRP 2026 sessions that correspond to their conference registration type (Full, Weekend, or One-Day Registration) by logging onto the ACRP website and visiting their My Learning Portal.
Reported by Gary Cramer
