Astrum

Our Medical Monitors (MM) ensure the safety and integrity of the trial participants throughout the trial, from initial design to study completion. The MM acts as the point of reference for study team members and investigative sites and evaluates safety events within a clinical trial.

The MM provide round-the-clock emergency coverage on all safety-related matters and is usually available 24/7/365. They’ll support investigators in eligibility assessments alongside clinical decisions. When requested, the MM participates in Safety Monitoring Committees to periodically review the safety and other relevant data.

The MM support and ensure data integrity and quality. They perform or supervise medical data review to ensure that study endpoints are correctly captured, and questionable data points are addressed with sites. The MM will communicate and discuss such cases with client representatives and with the Principal Investigators at the sites if necessary.

MM will inform the client’s Safety Officer of any potential SAEs discovered during the medical monitoring activities and will review and approve coding of the medical terms (MedDRA for medical data) and/or ATC coding for medication.

The lead MM ensures consistency and best practices across the sites/regions.

Additionally, the MM participate in Investigators’ meetings and team training (in the study protocol or the therapeutic area), including the sites (e.g., participation in Site Initiation Visits). If requested the MM will also review study documents (e.g., CSP, CRFs, ICFs, CSR…).