Winning More Study Awards With Feasibility Data You Can Defend

Feasibility questionnaires are the closest thing sites get to a job interview, and most sites treat them like a form to clear off the desk. Sponsors and CROs receive dozens of responses that all claim strong PI experience, an engaged patient population, and confidence in meeting enrollment targets. The ones that stand out are the ones backed by numbers the site can actually produce on request.

Why generic answers cost you studies

When a sponsor asks how many patients with a given diagnosis you see annually and you answer "approximately 200," you have told them nothing. They cannot tell whether that number came from a chart query or from a coordinator's best guess. Feasibility reviewers develop a fast instinct for padded numbers, and once a site overpromises and underenrolls on one study, that reputation travels within the sponsor and often to the CRO's other programs.

The sites that get repeat awards are usually not the biggest. They are the ones whose feasibility answers turned out to be accurate.

Build a standing data pack before the RFI arrives

You cannot assemble credible feasibility data in the 48 hours a CRO gives you. Build it once and maintain it quarterly. At minimum, keep current on:

• Patient counts by indication and ICD-10 code, pulled from your EHR or referring practice, with the date of the query noted
• Prior study performance by therapeutic area: screened, randomized, screen-fail reasons, and enrollment against target
• Time from site selection to first patient in for your last several studies
• Median time from contract receipt to full execution, and the same for IRB submission to approval
• Demographic breakdown of your database — age bands, sex, race and ethnicity, and preferred language
• Retention and dropout rates, with reasons where you have them

That last item is underused. Sponsors are increasingly worried about retention costs, and a site that can show a low withdrawal rate has a genuine differentiator.

Answer the question behind the question

When a feasibility form asks about your recruitment plan, the sponsor wants to know whether you have a source of patients that does not depend on the sponsor's central campaign. Say specifically what you have: a database of X consented contacts in this indication, referral agreements with named practices, a community partnership that has produced referrals before.

When they ask about staffing, they want to know if the coordinator will be spread across twelve studies. Be honest about capacity. Declining a study you cannot staff protects your standing far more than accepting and stalling.

Show your work on the enrollment estimate

Instead of a single number, give a short chain of logic: database size, expected eligibility rate based on the protocol's tightest criteria, historical contact-to-consent conversion, and the resulting monthly projection. Flag the criterion most likely to cause screen failures. Sponsors notice when a site reads the protocol closely enough to spot the washout period or the lab threshold that will cause problems, and that read often leads to a protocol amendment conversation where your input is valued.

Close the loop after the study

After each trial, record what you projected versus what you delivered and why the gap existed. Sites that can say "we projected 18, enrolled 15, and here is the specific inclusion criterion that caused it" build credibility no marketing slide can buy. Over several studies, that record becomes the strongest feasibility document you own.