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Monitoring and Coordination Services of Clinical Studies

Latin American System
Monitoring and Coordination Services of Clinical Studies

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.