Clinical Trial Site Feasibility in Miami and Puerto Rico: What Sponsors Should Verify

Begin with the protocol's hardest requirements

A broad therapeutic-area question is rarely enough. Asking how many patients have type 2 diabetes, ulcerative colitis or asthma may be useful for an initial conversation, but it does not show how many people match a sponsor's actual entry criteria.

Start with the eligibility requirements most likely to narrow the pool. These may include prior treatment exposure, laboratory thresholds, disease activity, prohibited medications, recent procedures, required washout periods or a particular diagnostic confirmation. Then review the visit schedule for assessments that might affect willingness or ability to participate.

There is a regulatory reason to take this seriously. Under 21 CFR 312.53, a drug-trial sponsor must select investigators qualified by training and experience. FDA's E6(R3) Good Clinical Practice guidance also places emphasis on fit-for-purpose planning and proportionate oversight. Neither a polished feasibility questionnaire nor a large database removes the need to establish investigator and site suitability.

Separate patient records from enrollable participants

Electronic medical records can identify a population worth evaluating. They do not automatically establish study eligibility, permission to contact an individual, current interest or appointment availability.

A credible estimate has several distinct stages: records suggesting a possible match; charts with enough information for preliminary review; people who can be approached through an appropriate pathway; individuals who are interested and available; participants who pass formal screening; and participants who are ultimately enrolled or randomized under the protocol.

A clinic's historical screening results may help inform an estimate when the populations and study demands are comparable. At Wellness Clinical Research, the patient-access approach draws on practice relationships and connected records, followed by protocol-specific clinical review. The public population figures describe records, not confirmed eligible participants. Those specialty categories should not be added together as though each entry represents a different person.

Test competition before relying on the forecast

Patient access does not exist in isolation. A neighboring study may seek the same diagnosis and treatment history, while a different protocol may compete for the same investigator time, procedure slots or candidate referrals.

A useful competition review looks beyond whether another study has a similar title. It compares critical eligibility criteria, expected enrollment periods, participant burden and whether local investigators or practices are already referring potential candidates elsewhere.

Site teams can add context about their own active workload and realistic outreach capacity without sharing confidential information from other sponsors.

For an enrollment forecast, the practical questions are whether the recruitment window overlaps, where potential candidates will originate and how many screening appointments the site can actually support each week.

Evaluate the investigator and the whole delivery team

Investigator fit is more specific than years in research. The sponsor should confirm relevant clinical experience, familiarity with the target population, ability to oversee protocol-critical decisions and real availability during screening and treatment.

Then examine the people who make the visits possible. Is there coordinator coverage for long appointments? Who manages unblinded work if required? Can laboratory and investigational-product teams support the schedule? Who provides follow-up when a participant misses a visit or reports a concern? Are key staff simultaneously starting other complex protocols?

WCR's public feasibility and startup overview describes a coordinated review of eligibility, connected records, nearby trials, procedure demands and staffing. The value of that model is not the software alone. It is the decision to bring clinical and operational reviewers into the estimate before committing to a number.

Ask which services are truly on-site

The phrase "we have access" can describe very different operating arrangements. An ECG performed in the research clinic is not scheduled the same way as a CT scan or endoscopy coordinated through a separate provider. Both models can work when the sponsor understands the handoff, scheduling, documentation and cost implications.

WCR's Miami Lakes and Vega Baja location pages identify on-site clinical resources, specimen-handling capabilities and services arranged through local providers. For example, Miami lists on-site sample-processing and cold-storage resources, while imaging and specialty procedures are described as coordinated local access unless confirmed otherwise during study review. Puerto Rico lists local clinical and laboratory capabilities subject to protocol-specific confirmation.

For every required assessment, ask who performs it, where, under what qualification or vendor agreement, how results return to the research record and whether the participant can complete it within the visit window. Review storage conditions, sample pickup schedules, backup procedures and equipment maintenance where they are relevant.

A procedure may be clinically available but not available on the day or turnaround schedule the protocol requires.

Treat Miami and Puerto Rico as separate execution plans

A connected network can share processes without pretending that two locations have identical populations or resources.

Miami Lakes brings a private-practice setting in South Florida, English- and Spanish-speaking staff, and access to multiple specialties. Vega Baja has its own investigator mix, community relationships, local services and operating hours. The same protocol may therefore need different referral sources, appointment planning or procedural arrangements at each location.

Sponsors should review each site's candidate pathway and investigator coverage separately. For studies enrolling across both markets, agree on a shared reporting definition but keep site-level assumptions visible. Do not combine specialty counts that may overlap or count referral access as enrolled participants.

Make the forecast an operating decision

Before selecting a site, hold a short feasibility review with the principal investigator, lead coordinator, recruitment owner and person responsible for startup. Ask them to walk through a realistic candidate's path from record or referral to screening, then through the longest or most demanding study visit.

A decision-ready review should answer:

• Population: Which eligibility requirements are confirmed in available records, and which require screening?
• Recruitment: Which contact or referral pathways are permitted, active and realistically staffed?
• Competition: Which nearby or internal trials overlap with this population during the planned enrollment window?
• Investigator: Who makes medical decisions, and how much direct oversight time is available?
• Procedures: Which assessments happen on-site, and which depend on outside appointments or vendors?
• Capacity: How many screening and follow-up slots can be supported without disrupting existing studies?
• Risks: What single delay or protocol requirement would most likely change the enrollment forecast?
• Ownership: Who will validate assumptions, report progress and revise the plan if actual conversion differs?

A better site-selection question

The result should be a baseline forecast, a more conservative scenario and the operational conditions that make each plausible. The sponsor may then choose to adjust site targets, expand the recruitment window, address procedural constraints or select a different site.

The question is not whether a research organization can identify patients with the disease. It is whether the proposed investigator and team can find, appropriately contact, screen, enroll and support the right people for this protocol while meeting its clinical and operational requirements.

That standard helps sponsors make fairer comparisons between sites in South Florida and Puerto Rico. It also gives sites room to describe genuine strengths without hiding constraints. Strong feasibility is not the most confident answer. It is the answer that survives contact with the protocol, the schedule and the people who will carry it out.

For a protocol-specific discussion of investigator fit, patient access and site readiness, submit a study to Wellness Clinical Research.