How to win more studies as a site

Why do capable sites lose studies?

The record gives sponsors reason to be careful. In a Tufts CSDD analysis of more than 150 studies and nearly 16,000 sites, published in 2013, 11% of sites in a typical trial enrolled no one and 37% under-enrolled. Only 39% met their target and 13% exceeded it.^⁠[1]

Enrollment is concentrated in a minority of sites. In the same Phesi cancer-trial analysis, 19% of sites enrolled exactly one patient.^⁠[2] A site without a strong record in the indication is judged on proxies: how it answers feasibility, how fast it opens, and whether its investigator has time.

Activation is the second filter. Ken Getz of Tufts CSDD said in March 2024 that about 40% of the North American sites a sponsor looks to engage will not activate. Some never get through contracting, budgeting or IRB approval, and some have trouble enrolling a single patient.^⁠[3]

What must a sponsor confirm before selecting a site?

Part of it is regulation. For drug studies under an IND, 21 CFR 312.53(a) says a sponsor shall select only investigators "qualified by training and experience as appropriate experts to investigate the drug." Under 312.53(c), the sponsor must also obtain a signed Form FDA 1572, which includes the investigator's commitment to "personally conduct or supervise" the investigation.^⁠[6]

ICH E6(R3), the good clinical practice guideline adopted in January 2025, sets two expectations for the investigator. Under section 2.2.1, the investigator should be able to show, from retrospective or current data, a potential to recruit the agreed number of participants in the agreed period. Under section 2.2.2, the investigator should have sufficient time, qualified staff and facilities for the trial.^⁠[7]

Past performance carries weight because it predicts future performance. A 2018 review of why trials fail found that sites with a record of meeting enrollment targets are more likely to meet them again, and that a site that has run 6 to 10 trials is more likely to enroll on time than one with fewer.^⁠[8] Our guide to how sponsors choose sites covers the sponsor's scorecard in detail.

Which levers can a site control?

None of these levers requires a larger patient population. Each requires evidence a sponsor can check.

How should a site answer a feasibility questionnaire?

Feasibility is where many sites win or lose a study. Questionnaires can run from 10 to 40 pages, and sites are typically not compensated for the work.^⁠[9],[10] A 2024 task force of sites, sponsors and CROs asked sites to use tools and data to make enrollment projections as accurate as possible.^⁠[10]

1. 1

   Triage the day it arrives

   Check the synopsis against your PI's interests, competing studies and coordinator capacity. A fast no protects the relationship better than a late, weak yes.

2. 2

   Count from the criteria

   Start from the inclusion and exclusion criteria, not the diagnosis code. Report the count after each group of criteria.

3. 3

   Check a sample of charts

   Have a coordinator review a sample from the bottom of the funnel, using a format like the chart review checklist, and record how many hold up. That ratio makes the estimate credible.

4. 4

   Commit below the pool

   Apply your own historical screen failure and consent rates to the eligible count. Commit to that result, not to the sponsor's per-site target.

5. 5

   Name the people

   List the PI, sub-investigator and coordinator who will run the study, with their current study loads.

6. 6

   Hold a turnaround target

   Pick a response time your team can always meet, such as two business days, and track it. Keep a standing site profile for questions that never change.

A criteria-based count is slow by hand because exclusions sit in notes, labs and medication histories. Bond Health's Identify stage reads structured and unstructured records against a study's criteria and shows the chart evidence behind each decision, so a coordinator can check a sample and send a count with its method attached.^⁠[16] The feasibility questionnaire template lists the questions sponsors ask most, and the glossary defines site feasibility.

How fast does a site need to start up?

In WCG's 2025 survey of 611 sites, budgets and contracts were the most-cited cause of start-up delays, named among their top three by 73% of respondents. Among independent sites and physician practices, 54% said they can start a study in under 60 days, against 9% of academic medical centers, community hospitals, health systems and site networks.^⁠[5]

Process changes are associated with faster start-up. In the NIH-funded Trial Innovation Network, investigator-initiated trials that combined a standardized start-up workflow, a dedicated site navigator and electronic tracking activated sites in a median of 133 days from IRB packet arrival, against 277 days for trials without the standardized workflow.^⁠[12] The glossary covers study start-up and site activation.

• A budget template and fee schedule approved in advance.
• Contract language your institution has already accepted with that sponsor or CRO.
• A regulatory packet ready to send: CVs, licenses, GCP training, lab certifications.
• One named start-up owner who tracks each study's days by step.
• Coordinator time reserved for the first patients before activation.

How do relationships, networks and technology affect selection?

Sponsor and CRO relationships

Many feasibility requests start with a person: the CRA who monitored your last study, or the CRO feasibility lead who read your last response. Keep those contacts current. After each study closes, ask what would put you on the next list. After each rejection, ask why.

Site networks

More trials are running through networks. Tufts CSDD reported in its March/April 2026 Impact Report that a growing proportion of clinical trials are conducted at academic medical center and network-affiliated sites.^⁠[13] Investors are buying into site networks. The Private Equity Stakeholder Project, an advocacy group, tracked 42 private equity deals in pharmaceutical services in 2025, including clinical trial sites.^⁠[14]

Joining one, by membership or sale, can bring an independent site sponsor relationships, central contracting and shared regulatory staff. The trade is fees or equity, and less control over which studies you take. If you stay independent, match networks on what sponsors see most: fast start-up and a clean performance record.

Technology signals

Sponsors also weigh a site's systems. WCG, citing a 2024 survey by the site software vendor Florence Healthcare, reported that 43% of sponsors view a site's adoption of the sponsor's own software as a key selection criterion, while 42% of sites want sponsors to accept the site's own technology.^⁠[4] The same survey found that 72% of sites had adopted feasibility software.^⁠[15]

List your CTMS, eSource, eISF and EHR screening tools in your site profile, and say you will use the sponsor's systems where required.

How should a site market itself and measure the results?

Marketing to sponsors is mostly making your evidence easy to find. Update a site profile and a performance summary every quarter and attach both to every feasibility response.

• Site profile: therapeutic areas, investigators and their experience, staff, equipment, languages spoken and systems.
• Performance summary: enrollment against commitment, start-up days by step, screen failure rate and deviations.
• Visibility: ACRP chapter meetings, SCRS events, sponsor site portals and CRO preferred-site programs.

What should I do this week?

• Pull enrollment against commitment for every study your site closed in the past three years.
• Time your last few feasibility responses from request to submission.
• Rebuild one open feasibility answer as a criteria-based funnel with a reviewed chart sample.
• Find the start-up step that took longest on your last study and write down why.
• Confirm each PI's active study load and clinic days, and name a sub-investigator for each.
• Draft or update your site profile using the feasibility questionnaire template.