IMIC

Translations

IMIC provides certified translation services of regulatory documents, study protocols, patient–oriented materials, and Informed Consent forms.

Feasibility Studies

IMIC has the capability to conduct feasibility studies to predetermine the proper study population in any therapeutic area. Therefore, IMIC has established a working relationship with governmental medical institutions to have access to their database and assess the possibility of placing trials in Mexico City or other areas of the country.

Patient Recruitment

IMIC patient recruitment is a well-integrated system that has been implemented to support the patient enrollment of all IMIC studies. The system has a contact service area that tracks all calls and screened patients, and continuously feeds information to the patient database that supports recruitment for future or ongoing trials. This department is in charge of developing advertising and follow-up strategies and materials.

Regulatory Support

IMIC provides support to sponsors in preparing all documents for the regulatory submission to the IRB's and the Ministry of Health agency in Mexico. This process is delegated to a specialist that deals entirely with the regulatory agency personnel.

In addition, IMIC prepares the importation of study drugs and works jointly with Mexican customs to guarantee drug availability on the initiation of all trials. We estimate that it could take approximately 60 days before the trial is initiated; from the time all study documents are received, reviewed, translated, submitted to the IRB and MoH, until the drug shipment arrives to our pharmacy.
IMIC - Flow Chart of Regulatory Approval Process

Development of Trials

Clinical trials can be conducted entirely in our facility, or in hospital environments according to the study protocols, by the study team that consists of a Principal Investigator, Sub-investigators, and study coordinators. All IMIC team members are full time and trained under IMIC policies and procedures, ICH and GCP guidelines, and Mexican and FDA regulations. All trial procedures are subject to QA controls, establishing uniform high-standard operation.