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