Site selection — Mexico

What CROs Evaluate When Selecting a New Clinical Trial Site in Mexico

When a contract research organization (CRO) — the company a sponsor hires to run its clinical trial — evaluates a new investigative site in Mexico, it scores the site against a practical checklist. The checklist below reflects what actually moves a site from the long list to the short list.

Seven things CROs score a new Mexican site on

• Recruitment evidence, not promises. Can this site enroll? CROs look for an identifiable patient base, documented referral pathways, and historical enrollment rates by therapeutic indication.
• A dedicated, certified study team. The principal investigator (PI), study coordinators, and research nurses should be dedicated to research. Certifications matter: Good Clinical Practice (GCP) training, current medical licenses, and documented delegation of authority.
• Regulatory readiness. Clinical trials in Mexico require authorization from COFEPRIS (the Federal Commission for the Protection against Sanitary Risk) and approval from a registered ethics committee (comité de ética en investigación, CEI) plus a research committee. No suspended authorizations, no unresolved observations.
• Documentation infrastructure. Electronic source (eSource) or well-controlled paper source, a clean electronic data capture (EDC) workflow, low query rates, and standard operating procedures (SOPs) for informed consent, adverse-event reporting, investigational-product accountability, and temperature-excursion handling.
• Quality track record. Zero critical findings from sponsor audits and no enforcement actions from health authorities — or, for a first-time site, a credible quality system: written SOPs, training records, and a named quality lead.
• Feasibility speed and accuracy. Complete, realistic feasibility questionnaires returned within days, with honest enrollment projections. Inflated projections that collapse at site initiation visit burn the relationship permanently.
• Contracting and budget discipline. A known legal entity, a standard budget template with separate line items (startup, per-patient, pharmacy, closeout), and realistic payment terms.

Bottom line: CROs select sites that de-risk enrollment, documentation, and timelines. Facilities impress on a tour; data wins the study.