Winning More Studies by Fixing Your Feasibility Answers

Feasibility questionnaires are the first — and often only — real audition a site gets. A sponsor or CRO reads a few dozen of them per study and decides, largely on the basis of numbers you supplied under time pressure, who gets a site visit and who gets a polite decline. Most sites treat the questionnaire as an administrative chore. The sites that win consistently treat it as a sales document backed by an internal database.

What sponsors are actually testing

A feasibility form looks like a data request. It is really a credibility test. Study startup staff are checking three things:

1. Can this site find the patients? Not "do they exist in your region" — can you reach them.
2. Do the numbers hold up? Enrollment projections that sail past what the site delivered last time get remembered.
3. Is this site organized enough to be low-maintenance? A form returned late, half-blank, or with "approximately" in every field signals what monitoring visits will feel like.

The most common failure mode is not overpromising. It is vagueness. "We see many patients with this condition" tells a sponsor nothing and invites them to assume the worst.

Build the dataset before you need it

You cannot produce good feasibility answers in the 48 hours you're given. You need a standing internal record you can query. At minimum, maintain by therapeutic area:

• Patient counts by indication, with the source named — EHR query, registry, referral log, prior study database — and the date pulled.
• Historical enrollment by study: screened, consented, randomized, screen-fail reasons, and the actual first-patient-in to last-patient-in span.
• Screen failure patterns. Knowing that half your failures in a diabetes program came from HbA1c ceilings lets you flag an inclusion range as a genuine risk rather than guessing.
• Recruitment channel performance: what proportion of enrolled patients came from your own database versus physician referral versus paid outreach.
• Startup timelines: contract execution to site activation, IRB turnaround, first patient consented.

Sites commonly discover, once they assemble this, that their real conversion rates differ substantially from the ones they've been quoting for years.

Answer the question behind the question

When a form asks for a monthly enrollment estimate, give the number plus one sentence of reasoning: "Four per month for the first three months, drawing on 180 patients in our internal registry who match the primary criteria, then two per month as we shift to physician referral." That single sentence does more for your standing than any capabilities deck.

The same applies to risk. If a protocol's washout requirement will disqualify most of your candidates, say so — and propose what you'd do about it. Sponsors rarely penalize a site for naming a real problem early. They do penalize sites that stay silent and then under-enroll.

Track your own hit rate

Log every feasibility submitted, the outcome, and the reason if you know it. Over a year, patterns appear: certain indications where you're never selected, certain CROs where you always are, questions you keep answering weakly. That log is also your negotiating evidence when a sponsor low-balls a recruitment budget.

A few practical rules

• Assign one owner. Rotating feasibility duty produces inconsistent numbers that sponsors notice across submissions.
• Keep a reusable core document — staffing, equipment, certifications, catchment demographics — so only the study-specific fields need new work.
• Return forms early. Early submissions get read carefully; late ones get skimmed.
• Never quote a number you can't reconstruct if asked. One challenged figure can cost you the study and the next one.