As the number of retina clinical trials continues to grow, selecting a contract research organization (CRO) has become a decision with implications far beyond enrollment projections and study budgets. Sponsors increasingly want evidence that a CRO can deliver experienced personnel, maintain endpoint quality, and navigate an increasingly crowded research landscape.

Those themes dominated a panel discussion titled “Elevating Clinical Trials: The Role of High Performing CROs” during Clinical Trials at the Summit in Las Vegas. Moderated by Emmett T. Cunningham Jr., MD, PhD, MPH, a serial entrepreneur and investor, the session brought together representatives of both sponsors and CROs to discuss what separates successful trial partnerships from those that struggle with delays, cost overruns, or enrollment shortfalls.

The discussion began with a question that framed much of the session: How can sponsors identify the right CRO team before a study begins?

Kim Maplestone, chief clinical operations officer at 4D Molecular Therapeutics, encouraged sponsors to focus less on presentations from company leadership and more on the individuals who will run the trial. “When you come for the bid defense, I don’t want to hear from your leaders. I want to hear from the study team,” she said. “A mediocre CRO with a really strong team can do well, and the opposite is true as well.”

Several panelists echoed that concern, noting that sponsors often evaluate organizations based on reputation rather than the personnel assigned to a study. Keith Lane, chief scientific officer of Ora, suggested that sponsors ask CROs to commit contractually to the project team presented during the selection process.

“We know turnover is an issue with CROs,” Lane said. “Bait-and-switch is an issue certainly with some CROs. Make the CRO guarantee it. Put it in the contract.”

Tanya Richardson, executive director of ophthalmology at Fortrea, suggested interview strategies to help sponsors better assess a CRO’s experience and capabilities. “I would approach it by asking the CRO, ‘What are the 3 biggest risks you see for my project, and how are you going to solve them?’” she said. “I would also ask them to present a case study where timelines did not go as planned. How did they respond, and how was the situation resolved?”

Panelists repeatedly discussed the importance of specialization. Some panelists represented broad-service CROs, while others focused exclusively on ophthalmology or specifically on retina. There was agreement, however, that sponsors should seek evidence of direct experience in the indication being studied.

Jason Tibbs, the ophthalmology lead for Syneos Health, encouraged sponsors to look beyond marketing claims and request objective evidence. “One of the very first questions the sponsor should ask is, can you show me the proof points and the evidence?” he said. “We should be looking not at promises, but at proof.”

That proof, panelists contended, should include more than enrollment metrics. Tibbs noted that studies can recruit successfully yet still fail because of poor endpoint quality. He recommended asking whether medical monitoring is conducted by board-certified ophthalmologists.

The issue of site relationships also emerged as a recurring theme. Brad Doerschuk, cofounder and chief executive officer of InFocus Clinical Research, said that long-standing connections with retina investigators have become increasingly important as competition for patients has intensified. “Relationships are not built overnight,” he said. “Powerful relationships are key drivers of successful clinical studies.”

According to Doerschuk, the number of retina clinical trials has increased substantially over the past decade, making current knowledge of site performance and competing studies increasingly valuable when forecasting enrollment.

Cost control represented another major focus of the discussion. Dr. Cunningham observed that clinical trial expenses have risen dramatically, creating pressure on sponsors and investors alike.

Desiree Beutelspacher, chief operating officer of Optigo Bio as well as a member of the clinical advisory board of Iuvo Clinical, pointed out that many budget problems originate during study planning rather than execution. Sponsors, she said, should clearly define protocol requirements and scope before requesting proposals. She also advocated milestone-based payment structures over detailed time-and-materials accounting models.

Maplestone offered a pragmatic assessment. “Never in my 20-plus years have I had a study that stayed on budget,” she said, drawing laughter from the audience. Her recommendation was straightforward: define responsibilities early and build contingency funds into project planning.

As the discussion shifted to studies that fall behind schedule, panelists pushed back on the idea that adding sites is always the solution. Instead, they emphasized identifying the underlying causes of poor enrollment and responding collaboratively. “When a study doesn’t perform as expected, the most important thing is that there’s a collaborative root-cause analysis,” Lane said.

David Tanzer, MD, chief medical officer of Lexitas Pharma Services, similarly emphasized flexibility and communication among sponsors, investigators, and CRO teams. He said that established relationships with investigators can help organizations identify problems earlier and develop practical solutions before delays become more serious.

The conversation ended with a discussion of how sponsors should evaluate potential partners. Although panelists offered different perspectives on staffing models, pricing structures, and operational strategies, they agreed on one point: performance records matter.

Dr. Cunningham closed the session with practical advice drawn from his own experience. “Call people who’ve used that CRO,” he said. “They will tell you whether it’s a good CRO.” RP