Mexico needs committee opinions at the institution before COFEPRIS will assess a protocol, and the two cannot run in parallel. Capture is a self-serve EDC with EU and US hosting that sponsors, CROs and sites can test free.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Study region
Mexico
Key points for studies in Mexico
Regulation
Secondary sources describe a sequential route. The host institution's ethics committee and research committee review the protocol and consent materials, and a biosafety committee does too if the study needs one. Only then is the file assessed by COFEPRIS. Sources disagree on the role of the national bioethics commission, so the institution-level model is the better supported one, but confirm it.
The data side of the file is a clear description of what is collected and how it is protected. Capture produces a blank eCRF PDF with a cover page, form index, visit-by-form matrix and every approved form printed empty, which suits the protocol and committee package. Every field change carries a timestamp, the user, the old and new value and the reason, and the trail cannot be edited through the interface. See audit trail software for clinical trials.
If committee review cannot overlap with COFEPRIS, a delay at the first site pushes everything back. Get committee calendars early, keep the consent text stable between the committee and the regulator, and avoid late protocol changes. A sandbox build lets sites see the forms before the committee does.
Blank eCRF · no subject data
Visit by form matrix
| Form | SCR | D1 | W2 | W4 | W8 | EOS |
|---|---|---|---|---|---|---|
| Demographics | X | |||||
| Vital signs | X | X | X | X | X | X |
| Laboratory | X | X | X | |||
| ECG | X | X |
3. Was the ECG performed?
☐ Yes☐ No
If No, complete question 4.
Who does what
| Step | Who | What is needed | Where Capture helps |
|---|---|---|---|
| Committee review | Site ethics committee, research committee, biosafety committee if relevant | Protocol, consent, investigator brochure | Blank eCRF PDF of the approved forms. |
| Regulatory filing | Sponsor or its local representative, via COFEPRIS platform | Protocol authorisation request with committee decisions | Edit checks and derived fields documented in the form. |
| Consent | Site investigator | Approved consent, participant signature, investigator signature | eConsent record with countersignature and signed PDF. |
| Site start-up | Hospital or clinic, principal investigator | Agreement, delegation, training | Site accounts, roles and site-level participant numbering. |
| Ongoing oversight | Sponsor or CRO monitors, COFEPRIS | Source verification, safety reporting, audit trail | SDV per field, queries, field-level audit trail. |
Roles summarise secondary sources. Confirm national detail with COFEPRIS and each site committee.
Set up visits, forms and checks free, share the blank eCRF PDF with each site committee, and pay only when real participants enrol.
Hosting and data protection
Capture hosts in the EU (Frankfurt) and the USA (N. Virginia), chosen at study setup. For a Mexican study the US region is closer; the EU region suits a sponsor that also has EU obligations. Neither is in Mexico, and Capture has no Mexican data centre. Mexican rules on personal and health data, and any rule on transfers abroad, are a question for local counsel, as is the effect of the 2025 changes to the federal data protection framework. If your sponsor is subject to the GDPR or HIPAA, read GDPR compliant clinical trial software and HIPAA vs GDPR for clinical trial data.
In Capture, site coordinators see participant names while researchers see coded IDs, and row-level security enforces that at the database. Data is encrypted with AES-256 at rest and TLS in transit.
EU (Frankfurt)
Default for EU-sponsored studies
US (N. Virginia)
Default for US-sponsored studies
Consent
The committee approves a specific consent text, so the version in the system has to match. Capture eConsent takes the participant on-screen signature, confirmed by a one-time email code, then the investigator countersigns with password re-authentication. Witness and legally authorised representative signatures are supported, and each signature is hashed to the exact document content. Language support is not claimed here, so confirm what is available before planning Spanish-language screens.
Meaning of signature
I have reviewed this adverse event and confirm the assessment of seriousness, severity and causality.
Signer
Dr. A. Ozola, PI
Password
••••••••••
Set-up
The AI study builder drafts visits and forms. Your team reviews every one before it is saved.
Site-level participant numbering and a site coordinator portal keep each institution separate.
Edit checks raise auto-queries; coordinators see names, researchers see coded IDs.
Enter sample participants, test e-signatures and the audit trail, and share the blank eCRF PDF with each committee.
Activate each site only when its committee decision and the COFEPRIS authorisation are in place.
Wider context
Mexican sites often form part of a regional or global programme. For other markets see Latin America, Brazil, Argentina, Chile and Colombia. For another emerging market with an emirate-by-emirate framework, see the UAE. For running sites across borders, read multi-site clinical trial management.
COFEPRIS is the federal regulator. Secondary sources say its remit covers Phases I to IV and that it depends on favourable decisions from the host institution's ethics and research committees. Confirm current procedures with them.
The NIAID ClinRegs profile says they may not be conducted in parallel. Confirm the current position with COFEPRIS before building your timeline.
Sources differ, from a three-month review once documentation is complete to reports of 2025 reforms aimed at shortening it. Ask COFEPRIS and do not rely on a blog figure.
No. Capture is hosted in the EU (Frankfurt) and the USA (N. Virginia). Capture has no Mexican data centre or office.
No regulator approves EDC software in that way. Capture provides an audit trail, e-signatures and role-based access, and your validated use is what an inspector looks at.
This page does not claim multilingual participant materials. Contact us about current language support before you commit to Spanish-language screens.
Yes. The free sandbox has every feature, with no credit card and no time limit. You pay only when you go live with real participants.
Keep exploring
Clinical trial software in Latin America
The regional view.
Clinical trial software in Brazil
Regional neighbour.
Clinical trial software in Argentina
Regional neighbour.
Clinical trial software in the UAE
Another emerging market.
HIPAA vs GDPR for trial data
Which regime applies to you.
Multi-site clinical trial management
Running sites across borders.
Pricing
Free sandbox, pay at go-live.
Build, test and share the blank eCRF PDF before any fee. You pay only when real participants enrol.