Everyone Talks About Site Selection — But Few Actually Get It Right

By Shruti Tibrewala, CEO and Cofounder, Double Blind Bio

Clinical trials depend on fast enrollment and reliable site performance. Yet, sponsor-site decisions often fail to reflect these priorities.

Most site assessments rely on feasibility forms and past trial participation. These signals provide only a narrow view of site capability and often miss the operational factors that determine trial success. The result is a process that slows down site selection and excludes many high-performing but lesser-known sites from consideration.

"Early feasibility often reduces sites to checkboxes such as prior studies, PI name, or therapeutic area,” explains Devora Henderson, CEO, Elevate Clinical. “That snapshot misses the real drivers of success, such as how quickly a team can activate, whether they have the staff and systems to handle volume, and how committed they are to the protocol. This is why strong performers get overlooked while familiar names are recycled even if they are already at capacity.”

Sponsors and CROs may be unaware that internal data sets sometimes mischaracterize recent site activity. Disconnects are common and highlight a broader need for direct visibility into operational readiness.

This article highlights the blind spots in today’s clinical research site evaluation process—outdated data, limited operational insight, and overreliance on reputation—and shares practical ways sponsors and sites can improve alignment through real-time visibility, standardized readiness data, and more transparent collaboration.

What Sponsors Evaluate — And What Sites Wish They Knew

The typical process for identifying sites leans heavily on reputation. Sponsors often look for prior trial involvement, publications, and KOL status as proxies for quality. While convenient, these factors do not always predict prompt start-up timelines, correlate to the number or skill of available staff, or indicate patient access.

Some sponsors also stick to sites only with prior therapeutic area experience. To determine therapeutic experience, sponsors may ask whether a site has experience with a certain modality, such as CAR-T. They might review how many studies a PI is currently leading or whether the site has supported complex protocols. But these checks are not always balanced by questions about operational capacity. Even if these sites are promising, they may already be overloaded. Because there’s no standardized way to gauge a site’s real-time activity level, sponsors often rely on outdated data or self-reported workload. In practice, the only reliable indicators come from recent activation timelines, enrollment rates, or staffing-to-study ratios — information that most feasibility forms don’t capture.

“At Elevate, we focus on telling the operational story that a feasibility form cannot capture. We translate day-to-day readiness like staffing levels, start-up speed, and patient access into sponsor language. When sponsors see that clarity up front it builds trust and helps them make decisions based on reality rather than assumptions,” says Henderson.

Capable but lesser-known sites often remain invisible because they fall outside CRO-maintained lists or do not surface through traditional outreach. These internal lists are typically refreshed only when a new trial begins or a sponsor requests updates — sometimes months or even years apart — meaning recent high-performing sites may not appear at all. Traditional outreach often relies on investigator meetings, prior sponsor relationships, or email surveys sent to known networks. For example, some physician-led groups treat patients in multiple therapeutic areas but are excluded from trials outside of their most well-known indication. These methods rarely reach independent or community-based research groups that lack large marketing teams or prior sponsor ties. As a result, sites that enroll quickly and efficiently can remain overlooked simply because their performance isn’t captured in the usual channels or updated datasets.

Lastly, when a site does not provide a complete feasibility form, skipping over inclusion and exclusion criteria or withholding specific projections, sponsors often assume the team did not take the protocol seriously and, therefore, rule it out. From the site’s perspective, feasibility forms frequently feel repetitive and poorly matched to the study. And in practice, feasibility forms are usually completed by operational staff, not PIs. Sponsors may want projections on enrollment and timelines, but these answers are often estimates pulled together quickly without deep access to centralized databases or prior benchmarks.

The CRO Middle Layer: Support Or Obstacle?

CROs often connect sponsors and sites, but their tools, data sources, and traditional approaches can be limiting. For one, their internal site databases may not reflect a site’s recent trial activity or performance signals. In some cases, slow data updates misclassify sites with active portfolios as inactive.

Because of this, many sponsors no longer rely solely on the CRO’s evaluation. Some run their own feasibility process in parallel to gain greater confidence in site fit. This creates more work for the sponsor and reflects its lack of trust in the CRO’s information.

Although CROs understand that fast enrollment depends on finding the right sites, without tools that offer real-time access to staffing, patient volume, and infrastructure, their evaluations often miss the mark. Their proposals focus on timeline projections and general strategies, not verified insights into individual site readiness or performance. Therefore, the depth of their operational vetting is often superficial.

Rethinking Site Capability Beyond Therapeutic Area Experience

Filtering sites based on prior experience in a specific disease area is common but not always helpful. Sites may have the operational ability to support a protocol even if they have not worked in that exact indication before. Clinical and research experience do not always align neatly with therapeutic boundaries.

Sponsors who focus instead on infrastructure readiness, start-up speed, data quality, and ability to execute complex protocols may uncover stronger options. Many sites that perform well do not have the relationships or marketing language to convey that value. Sponsors can surface these sites by broadening how they source and validate candidates — for example, by cross-referencing public trial registries with local investigator networks or reviewing recent activation timelines rather than historical participation. Direct engagement with site networks and technology platforms that track operational readiness can also reveal capable sites that traditional lists miss.

“Sponsors judge sites by the information in feasibility reports. Thus, the information that is collected needs to detail what they are capable of,” explains Angela Pontius, a biotech clinical development operations leader. “If the questions do not surface key capabilities and the answers are not specific, she adds, strong sites may be dismissed without due consideration.”

Better Alignment By Way Of Operational Transparency

Sponsors often assume that performance will be unpredictable and enrollment gaps are inevitable. That’s why they often plan for a portion of their selected sites to fail to enroll. This assumption reflects the broader uncertainty in the selection process and the low confidence in feasibility data. But better data sharing could make this less of a gamble.

If sponsors had access to real-time information on staffing, patient mix, audit history, and timelines, they could improve both planning and execution. If sites could standardize how they present that information and reuse it across studies, they would improve their visibility and likelihood of selection. Emerging tools now allow real-time visibility into staffing, patient flow, and readiness — data that once lived in spreadsheets and emails.

Sites And Sponsors Both Deserve Better

Ultimately, trial success requires a shared understanding of operational realities. Sponsors need clarity on what sites can do. Sites need better ways to communicate that clearly.

This change will not happen overnight. But the tools now emerging — along with a growing desire on both sides for alignment — create an opportunity to rebuild the process around truth, not guesswork.

"Trials are getting more complex, and timelines are tighter. The margin for misalignment between sites and sponsors is shrinking. Clear and transparent communication about operational realities is essential if we want to get therapies to patients faster,” says Henderson.  

For that to happen, everyone in the equation must participate. 

Call To Action:

• Sponsors: Ask operationally specific, protocol-relevant questions early in your site selection process.
• Sites: Build a clear, data-backed profile that communicates strengths beyond the PI’s CV.
• Vendors: Prioritize workflow integrations and reduce administrative overhead.
• Funders: Support infrastructure that works for both sites and sponsors, not just one side.

Acknowledgement: The author would like to thank Devora Henderson and Angela Pontius for their contributions to this article.

About The Author:

Shruti Tibrewala is the CEO and co-founder of Double Blind Bio to simplify site operations and improve transparency across clinical trial workflows. Shruti has over a decade of experience at the intersection of life sciences, research, and technology, with previous roles at Flatiron Health and Novartis. She holds a B.S. in Biology from Stanford University and an MBA and MPH from the University of California, Berkeley.