Site selection is a due-diligence exercise, not a relationship one. By the time a sponsor or CRO issues a feasibility questionnaire they are working against a defined set of criteria, and the sites that come through it tend to be the ones that can evidence past performance rather than describe intent.
The Feasibility Questionnaire Is the First Filter
Feasibility is where a sponsor gathers structured information — patient population, equipment, staffing, competing trials, historical enrollment — and evaluates candidate sites against a common rubric before regulatory submissions begin. A site that returns a questionnaire slowly, or returns it with optimistic numbers it cannot support, has usually made the decision for the sponsor.
The most useful answer a site can give at this stage is often a negative one. Declining a protocol that does not match your population costs a sponsor nothing and buys credibility for the next one.
Past Performance Is the Strongest Signal
Where a site has worked with the sponsor or CRO before, historical metrics carry more weight than anything written on a questionnaire. The measures typically reviewed are:
- Actual enrollment achieved against the target the site committed to
- Time from site initiation to first patient enrolled
- Retention and dropout rate across the study
- Protocol deviation rate
- Data query rate and time to query resolution
In a survey of decision-makers at biopharmaceutical companies and CROs, 42% put having patients ready to enroll immediately after the site initiation visit above every other attribute. Good data entry practices came second at 25% and accessible site personnel third at 23%. Updated equipment and facilities — the thing sites most often lead with in their own materials — was named by 1%.
Start-Up Speed Is Itself a Selection Criterion
Study start-up covers site qualification, contract and budget negotiation, IRB approval, and assembly of the regulatory document package. Run sequentially it takes months. Run in parallel, with a site that can execute a confidentiality agreement the day it arrives and has current CVs, licenses, lab certifications, and training records already on file, it takes considerably less.
Delays here are expensive and highly visible, which is why start-up performance is increasingly assessed before selection rather than tolerated after it.
Data Quality Is Judged Continuously
Enrollment gets a site selected; data quality determines whether it is selected again. Query rates, deviation rates, and the outcome of source data verification during monitoring visits all feed back into the sponsor’s view of the site. A site that enrolls quickly and generates a heavy query burden is not a high-performing site — it has moved the cost rather than removed it.
Representation Has Entered the Calculation
The FDA’s draft guidance on Diversity Action Plans asks sponsors to set enrollment goals for underrepresented populations and to describe the strategies they will use to meet them. Hispanic and Latino participants remain underrepresented in United States clinical research relative to the population, so a site whose catchment reflects that population is answering a question sponsors now have to answer in writing.
Geography matters here in a way it did not a decade ago. A site’s community is part of what it offers.
Where Anmed Health Fits
We are a single site in Kendall, Miami, running Phase I through Phase IV protocols with a bilingual team and a patient base drawn from the surrounding community. Our regulatory documents are maintained on file, and we return feasibility assessments quickly enough to be useful during site selection rather than after it.
If a protocol is not a fit for our population, we would rather tell you at feasibility than discover it at month four.
Request a Site Feasibility Assessment
Send us a protocol synopsis and our team will respond with enrollment projections, start-up timelines, and confirmation of site capabilities. Confidentiality agreements are executed before protocol review.
This article is for general educational purposes and is not medical advice. It does not describe or promote any investigational treatment. Screening does not guarantee eligibility for a study, and study participation requires medical evaluation. Speak with a licensed healthcare provider about your individual situation.
