What LATAM sites should bring to a summit: the feasibility data that opens doors

· Julio G. Martinez-Clark, CEO, bioaccess®

Most Latin America (LATAM) sites arrive at a summit with a polished capability deck and leave with polite conversations that go nowhere. The problem is not the quality of the sites. It is the evidence. Feasibility teams do not award studies for slides about commitment and passion. They award studies to sites that can prove, with specific numbers, that they can start fast, enroll real patients, and deliver clean data.

Feasibility teams want evidence, not generic decks: randomized patients per indication, real startup timelines, and screen-failure rates. The evidence pack that opens doors at a site summit.

Most Latin America (LATAM) sites arrive at a summit with a polished capability deck and leave with polite conversations that go nowhere.

November 6, 2026

7

min read

By

Julio G. Martinez-Clark, CEO, bioaccess®

LATAM

Feasibility

Site Selection

Summits

The mistake: a capability deck is not evidence

A typical site deck spends ten slides on history, mission, photographs of the building, and logos, and one vague slide on experience. From the sponsor side of the table, that order is backwards.

I sit on that side often. As chief executive officer (CEO) of bioaccess, a first-in-human (FIH) contract research organization (CRO), and CEO of Amavita Research Services, a Miami cardiovascular trial site, I review site capabilities the way feasibility teams do: skeptically, quickly, and against a protocol. A claim without a number behind it is treated as a hope. A number with a date, an indication, and a source behind it is treated as evidence.

Your deck belongs in a follow-up email. What you bring to the meeting is a one or two page evidence pack, built from the five sections below.

Randomized patients, by indication, in real numbers

The first question in any feasibility review is simple: how many patients has this site actually randomized, in this indication, recently?

Answer it in a table, not a paragraph. For each therapeutic area, list the indication, the phase, the number of patients enrolled, the number randomized, and the time period. Separate enrolled from randomized, because feasibility teams know the difference and will discount any site that blurs it. Recent experience matters more than lifetime totals, so show the last three years first and put older work below it.

If your numbers in an indication are small, say so and explain the context. A site that randomized eight patients in a rare condition, on time, with no major protocol deviations may be stronger than a site claiming hundreds of patients with no breakdown. Precision builds trust. Inflated totals destroy it the moment a feasibility questionnaire asks you to reconcile them.

Bring the same discipline to recruitment sources. State where randomized patients came from: your own clinic population, referring physicians, a patient database, or community outreach. A sponsor needs to know whether your enrollment engine is repeatable.

Startup timelines you have actually achieved

Every site claims it starts fast. Very few can show the dates.

For your last several studies, record the real milestones: ethics committee submission, regulatory authority submission, approval, contract execution, site activation, and first patient screened and randomized. Then calculate the intervals that matter, above all submission to activation and activation to first patient in.

Present the range and the median, not only your best case. Feasibility teams build timelines from medians. A site that honestly reports its median, and can explain what drove its slowest study, is more credible than a site promising an activation speed it has never once achieved.

Also name your bottlenecks and what you changed. Did contract review slow you down until you adopted a standard template? That candor tells a sponsor your timelines are managed, not wished for.

Screen-failure rates, and what drives them

Nothing separates experienced sites from hopeful ones faster than a serious answer on screen failures.

Report your screen-failure rate by indication for recent studies, and then do the part most sites skip: break down the reasons. Which eligibility criteria excluded the most patients? Was it a laboratory value, a washout period, a comorbidity, an imaging requirement, or a medication restriction? How many patients were lost between consent and screening because they changed their minds or could not attend the visits?

This matters commercially, not just scientifically. Sponsors build feasibility projections around expected screen-failure rates. If your data shows a criterion will exclude most of your clinic population, raising it early, with numbers, can shape the protocol discussion and marks your site as a partner rather than a vendor. Hiding a high rate helps no one: the sponsor will discover it during enrollment, at the worst possible moment.

Add your retention numbers too: completion rates and missed visit rates. They show what happens after the promising enrollment chart ends.

Staffing and coverage, by role and by backup

Feasibility teams are not only buying a principal investigator (PI). They are buying a team that still functions when someone is on vacation, ill, or overloaded with competing studies.

List your team by role: the PI, sub-investigators, coordinators, recruitment staff, pharmacy and laboratory support, and quality assurance. For each key role, state how many people hold it, their research experience, current study load, and who provides backup. State how many studies your coordinators carry at once: coordinator overload is a common hidden cause of slow enrollment and poor data quality.

Be specific about coverage. When can participants be seen? Who answers a sponsor query after hours? Who handles a serious adverse event on a weekend, and how quickly can the PI be reached? Sponsors running early phase and FIH work care deeply about these answers, because participant safety and rapid decision-making depend on them.

Summarise training rather than dumping it: state that Good Clinical Practice (GCP) training is current, and be ready to produce certificates on request.

Equipment and facilities, in specifics

"State of the art facilities" is a phrase that means nothing in a feasibility review. Specifics mean everything.

List the equipment a protocol team would actually check for: freezer and refrigerator capacity with temperature monitoring and alarm response, centrifuge capability, electrocardiogram machines, imaging access and turnaround time, laboratory processing arrangements, emergency equipment, and secure drug storage. For each item, give the detail that removes a follow-up question: the temperature range, the monitoring system, the distance to the imaging provider, or the backup plan if a freezer fails.

Describe the participant-facing space with the same precision: examination rooms, a dedicated research area, and the visit hours you can offer. If your site has limitations, state them plainly, together with the workaround you already use. A known limitation with a working solution is a manageable risk. One discovered during a site selection visit is a reason to choose another site.

How to run the fifteen-minute meeting

Summit meetings are short, and most sites waste them. They spend twelve minutes presenting slides and three minutes on the only conversation that matters.

Reverse the ratio. Open with one sentence about your site and the therapeutic areas where your evidence is strongest. Then hand over the evidence pack and walk through it in the order above: randomized patients, startup timelines, screen failures, staffing, and facilities. Watch where the sponsor representative stops and asks questions. That is the live feasibility assessment, and it tells you which studies to pursue with that sponsor.

Use the remaining minutes for two questions of your own: which indications and phases are priorities for their pipeline this year, and what has disappointed them about site performance in recent studies? Their answers tell you how to position your follow-up.

Close by agreeing on a concrete next step with a date: a feasibility questionnaire you will complete, an introduction to the feasibility lead, or a call with your PI. Leave the printed pack behind. After the summit, the sites that left evidence on the table are the sites still in the conversation.

The standard to hold yourself to

At Amavita Research Services, our Miami cardiovascular site, we hold ourselves to this same standard: verifiable specifics, including more than 18,000 active cardiology patients and zero Food and Drug Administration (FDA) Form 483 findings. At bioaccess, we run early stage trials anywhere from Canada down to Argentina, and we choose sites the way sponsors do, on evidence.

That is the shift this article asks of every LATAM site preparing for a summit. Stop selling potential. Bring proof. A site that can show randomized patients by indication, honest startup timelines, understood screen-failure rates, a staffed and covered team, and specific facilities does not need a longer deck. It needs fifteen minutes and a table to put the evidence on.

*Julio G. Martinez-Clark is CEO of bioaccess and CEO of Amavita Research Services.*

Julio G. Martinez-Clark is chief executive officer (CEO) of bioaccess\u00AE, a first-in-human contract research organization running early-phase trials anywhere from Canada down to Argentina, and of Amavita Research Services, a Miami cardiovascular research site he has operated for seven years with zero United States Food and Drug Administration (FDA) Form 483 inspection findings. He founded Global Trial Accelerators\u2122, a podcast for medtech and biotech founders navigating first-in-human studies.

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