- Evaluation and selection of potential investigators and sites.
- Detailed review by experienced personnel of all study documents so that it complies with international
and local regulations, especially in reviewing the ICF.
- Constant communication with the sites for prompt delivery of documentation, assistance with
administrative issues regarding study approval in all the institutions, support for the Principal Investigator
and his/her team to assure a proper understanding of all aspects of the study.
- Submission of documents to IRB and Central Ethics Committees, as well as follow-up of the approval
process, handling all queries as soon as possible.
- Submission of initial documentation to the regulatory authorities in Peru, this include the INS (National
Institute of Health) and DIGEMID (General Office of Medication, Supplies and Drugs), following up on
- Submission of all documentation requested by the Peruvian regulatory authorities, IRB and CEC in a timely
manner, this includes submission of SAEs, amendments, interim and final reports.
- Organization, administration and management of budget.
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