We offer complete clinical trial services, for example:
- Patient recruitment and selection of right patients for the study
- Completion of protocol’s study visits, along with its responsibilities, such as CRF and eCRF completion, communication with IRB / IEC, IP management, among others.
We also help sponsors that have no presence in Mexico by providing them with all regulatory services, such as:
- Preparation of the regulatory documents needed for the submission to the Mexican Ministry of Health, Cofepris (Comisión Federal para la Protección contra Riesgos Sanitarios) for review and approval.
- Submission of the regulatory package of the clinical protocol to the Cofepris.
- Import permits for study drug.
- Scheduling and attending appointments with Cofepris’s deparments on behalf / along with the sponsor.
- Certified translation of documents.
- Interim progress reports and final reports to Cofepris.