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Clinical Study Monitoring and Coordination Services

Latin American System

Clinical Study Monitoring and Coordination Services

We provide services for Phase 1, 2, 3 and 4 Studies. We have a team with extensive experience conducting clinical studies.

Latin American System

We provide services for Phase 1, 2, 3 and 4 Studies

We have a team with extensive experience conducting clinical studies, organized into 5 stages:

1. Study set up

Site and Investigator Feasibility.
Site and Investigator Qualification.
Agreement and Contract Management.
Clinical Trial Insurance Management.
Payment Management.

2. Regulatory activities

Assembly of Regulatory Dossiers.
Ethics Committee Authorization/Approval Management.
Institutional Committee Authorization/Approval Management.
Ethics Committee Progress Reports.
Regulatory Authority Progress Reports.

3. Study initiation visits

Research Team Training.
Assembly of Study Binders.
Management of Distribution of Materials and Supplies to Research Sites.

4. Periodic monitoring visits

Source Document Monitoring.
Essential Document Monitoring.
CRF Monitoring.

5. Study and site close-out visits

CRF Close-out.
Management of Retrieval of Materials and Supplies from Research Sites.

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