Rigorous monitoring of clinical trials by our Clinical Research Assistants (CRAs).

1. From study nursing to study monitoring

• Study nursing.
  • Aid in correctly filling-out CRFs and source documents.
  • Investigator assistance.
• Complete or partial monitoring in order to verify all or just some (20%, 50%, etc.) CRFs.
  • Kick-off meeting with investigators and the entire study team..
  • CRFs monitoring with verification of source files.
  • Consent form verification.
  • Monitoring of Adverse Events (AE).
  • Declaration and monitoring of Serious Adverse Events (SAE).
  • Submission, monitoring and validation of requests for clarification (Queries).
  • Drafting of monitoring reports.

Saves considerable time during sponsor Clinical Research Assistants (CRAs) visits in addition to reducing the number of overall on-site visits required.