We provide services for Phase 1, 2, 3 and 4 Studies. We have a team with vast experience in conducting clinical studies.
Studio set up
- Feasibility of Centers and Researchers.
- Qualification of Centers and Researchers.
- Management of Agreements and Contracts.
- Research Insurance Management.
- Payment Management
Regulatory activities
- Preparation of Regulatory Dossiers.
- Management of Authorizations/Approvals Ethics Committee.
- Management of Authorizations/Approvals Institutional Committees.
- Progress Reports Ethics Committee.
- Regulatory Entity Progress Reports.
Study initiation visits
- Training for the Research Team.
- Assembling the study Binders.
- Management of Distribution of Materials and Supplies to Research Centers.
Periodic monitoring visits
- Monitoring of Source Documents.
- Monitoring of Essential Documents.
- CRF monitoring.
Closing visits of studies and centers
- Closure of CRFs.
- Management of Withdrawal of Materials and Supplies from Research Centers.