Clinical Trial Services
We work with international Sponsors and CROs in Mexico as well as those that have no local presence in Mexico but wish to run clinical trials in our country. For the latter we offer extra services such as:
Preparation of Regulatory Documents
Submission Of The Regulatory Package
We help you submit the regulatory binder of the clinical protocol to the Cofepris.
We can obtain import permits for study drugs and materials.
Scheduling And Attending Appointments With Cofepris
We can help our Sponsors schedule appointments with Cofepris and attend meetings on their behalf.
We can also help Sponsors obtain certified translations of any document, like interim progress reports and final reports to Cofepris.
IRB / IEC submission
Our commercial IRBs help speed up your regulatory process.
Patient recruitment and selection of right patients for the study
Coordination of protocol’s study visits, CRF completion, IRB reporting, etc.