When a contract research organization (CRO) evaluates a new site in Mexico, enthusiasm does not move the decision.
November 6, 2026
7
min read
By
Julio G. Martinez-Clark, CEO, bioaccess®
Start with recruitment evidence, not enthusiasm
Every site says it has patients. A CRO cannot take that claim to a sponsor. What we need is documented recruitment evidence, indication by indication.
For each therapeutic area you want to be considered for, show the population you actually serve. How many patients with that condition did you see in the last twelve months? How many met the broad age, diagnosis, and treatment patterns early-phase protocols usually require? How many were excluded by uncontrolled comorbidities, prohibited medications, or inability to return for frequent visits? Your numbers must come from records, not memory.
The strongest sites keep a recruitment evidence file for their top indications: de-identified counts drawn from clinic records, referral sources by name and type, a short note on how those patients would be contacted under local privacy and ethics rules, and the competing studies already running in the same population. Overlap is one of the first reasons projected enrollment fails.
Show your catchment honestly, including travel time and retention support. A smaller, proven population that completes visits beats a large, theoretical one that disappears after screening. At Amavita in Miami, our cardiology population of more than 18,000 active patients only matters because it is documented and searchable. If you cannot show the evidence, a CRO must assume the patients are not there.
A dedicated research team, not borrowed clinic staff
The second question is who will do the work. A respected principal investigator (PI) opens the door, but a borrowed clinic team closes it.
A CRO looks for a PI with relevant specialty experience, current training in Good Clinical Practice (GCP), and real time protected for research. We look for named sub-investigators who will cover absences, and study coordinators who work in research as their primary job. If every coordinator also carries a full outpatient clinic load, the study will compete with routine care every day, and routine care will win.
Training records should be current and filed before anyone asks: a signed, dated curriculum vitae (CV) for each key member, GCP certificates, medical licenses where applicable, and training on the systems the site uses. For first-in-human work, we also ask how the team handles intensive safety monitoring, emergency transfers, and round-the-clock investigator availability during dosing. Requirements vary by protocol, so we value a rehearsed process, not a promise to figure it out later.
Tell us how long your coordinators have been with you and who trains a replacement. Stability signals that enrollment, visit windows, and safety reporting will not collapse when one person leaves.
Documentation infrastructure that can withstand monitoring
Good medicine without good documentation does not produce usable trial data. We test whether that discipline exists before the first participant is enrolled.
Source documents must be complete, attributable, dated, and traceable to the original observation. If your source is electronic, show how access is controlled, how corrections are tracked, and how records will be made available to monitors. If your source is paper, show how it is filed, protected, and retrieved. Either model can work. An uncontrolled mix of both usually cannot.
We also look at electronic systems experience. Has the team worked with electronic data capture (EDC) systems and central laboratory portals? You need staff who have entered data promptly in a regulated study before, understand query resolution, and can meet the data entry timelines a sponsor sets.
Regulatory file discipline is the third leg. Maintain a trial master file structure, even between studies, with standard operating procedures (SOPs) staff actually follow. Version control, training logs, delegation logs, calibration records, and temperature monitoring for investigational product storage are how an inspector reconstructs what happened. At Amavita, maintaining zero findings on a United States Food and Drug Administration (FDA) Form 483, the form inspectors use to record observations, came from treating that discipline as daily work. A Mexican site with the same habit earns confidence quickly.
Ethics committee and COFEPRIS pathway familiarity
A site does not need to be a regulatory consultancy, but it must know its own approval pathway cold.
In Mexico, that means working familiarity with the local research ethics committee and research committee review at your institution, and with submissions to the Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), Mexico's federal health regulator. We ask which ethics committee you use, how often it meets, what a complete submission package from your site looks like, who prepares it, and what experience you have with COFEPRIS submissions for clinical trials, amendments, and safety reports.
Timelines vary by protocol, committee calendar, and the completeness of the submission, and any site that guarantees a fixed approval date should expect hard follow-up questions. What a CRO wants is a site that can describe the sequence accurately, flag where delays usually occur, submit a clean package the first time, and document what must not start before approvals are in place.
If you are new to sponsored research, say so, and show the compensating structure: an experienced regulatory adviser or a committee relationship you have already established. Honest inexperience with support is evaluable. Unexplained confidence is not.
Feasibility questionnaire speed and accuracy
The feasibility questionnaire is not paperwork. It is the audition.
Speed matters because sponsors build site lists on fixed decision dates. A complete response returned within a few business days signals an organized site. A response that arrives three weeks later, after reminders, tells a CRO how data queries and safety reports will likely be handled later.
Accuracy matters more. Every number should be one your team can defend. Tie enrollment projections to the documented population above, discounted for eligibility, competing studies, and consent rates. Confirm claimed equipment is on site, calibrated, and available. If a protocol requirement does not fit your facility, say so clearly. A fast, honest no builds more trust than a slow, optimistic yes on everything.
Assign one person to own the questionnaire, have the PI review it before submission, and keep the supporting evidence ready to send.
Red flags that quietly end the conversation
Most sites are never told why they were passed over, so I will name the patterns that end evaluations early.
Inflated enrollment claims with no source data are the most common. So are questionnaires signed by the PI but clearly completed without investigator review, with answers that contradict the protocol. Other red flags include no dedicated coordinator, no backup investigator coverage, expired GCP training, an ethics committee the site cannot name, and storage for investigational product with no temperature monitoring.
Communication itself is evidence. Missed calls, unsigned confidentiality agreements sitting for weeks, and long silences after receiving a protocol predict how activation will go. Together, they tell a CRO that placing a study, especially a first-in-human study, would add risk the sponsor does not need.
Prepare your evidence before the first questionnaire arrives
Do not wait for a questionnaire to start preparing. Build a standing site evidence package now, update it quarterly, and keep it ready to send within one business day.
That package should contain a one-page site profile, documented patient counts for your five strongest indications, team CV and GCP files, a facilities and equipment list with calibration status, your ethics committee and COFEPRIS submission experience described step by step, and your SOP list. Add a short note on studies completed, including enrollment against target and retention, stated exactly as the records show.
bioaccess runs trials anywhere from Canada down to Argentina, and Mexico is where prepared sites can distinguish themselves fastest, because the evaluation bar is knowable in advance. Sites that treat feasibility as an evidence exercise, not a sales exercise, get onto lists and stay on lists. Build the file before we ask, and the conversation shifts from whether you are ready to which study you should take first.
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.