Medical Monitoring
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Protecting patients’ safety in the trials we run is our highest priority. MAC succeeds by balancing awareness of industry changes with a focus on innovation and quality.
MAC’s Medical Affairs Team oversees the medical monitoring of our trials. The team comprises experienced physicians and key opinion leaders (KOLs), with medical oversight provided by our Chief Medical Officer (CMO). A Medical Monitoring Plan is developed to document medical monitoring activities and associated responsibilities for the trial. This ensures adherence to the protocol, enrolment of eligible subjects, and timely review of safety and efficacy data. This Plan is a living document that is created during the trial start-up by MAC’s Medical Affairs Team. The plan is finalised and executed prior to the first patient being enrolled in the study, and maintained throughout the lifecycle of the trial, reviewed annually or more frequently, depending on the trial’s phase and scope. The annual review cycle and any ad hoc/other updates are managed by MAC’s Medical Affairs Team, considering any new safety information or risks as they become known during trial conduct.
The Medical Affairs Team also provides comprehensive medical monitoring support to sponsors, while acting as expert points of reference for both investigator sites and study sponsors. Medical monitoring activities are defined and agreed up front, in line with MAC’s standard operating procedures (SOPs), the project scope, and will cover activities including:
- Input into study design and protocol development
- Review of safety information
- Protocol compliance and deviations
- Subject eligibility
- Study team and site training
- Review of Adverse Events (AEs) and Serious Adverse Events (SAEs)
- Review of Safety Data (e.g., laboratory or cardiac data)
- Review of Medical Coding
- Review of Tables, Figures, and Listings (TLFs) and other data analyses
- Input into the Clinical Study Report (CSR)
During study conduct, the Medical Affairs Team ensures consistency across all points through cross-site medical meetings.