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Medical Monitoring

Our Medical Monitoring services at AWINSA start before the study starts. The medical monitors help in reviewing some documents like IBs, protocols, CRF, DSMB charter and supporting documents. The medical monitors participate in the development of training materials to be used at the Investigator meeting and Site Initiation Visits (SlVs). They provide training in the therapeutic area, study indication, protocol, and safety reporting issues to project team and Investigator sites. They review safety monitoring plan and statistical analysis plan.

During the course of the trial, the Medical monitors are available for any medical/scientific consultation and provide guidance and support to the sites and the study team for issues like patient eligibility and safety questions. They review.

  • Line listings (LL) related to efficacy and safety parameters
  • All SAEs reported by the Investigators and, provide inputs to the safety team andany follow up queries
  • Protocol deviations from a medical/safety perspective and let the client know the plan of action from medical perspective
  • Protocol amendments, collaborate with medical and pharmacovigilance teams of Sponsor.

  • After the end of the study, the Medical monitors:

  • Review data management coding for consistency
  • Review tables, Listings and Figures
  • Prepare the safety reports
  • Review the Clinical Study Report (CSR)
  • Provide recommendations for future studies/development
  • case-processing