Medical Monitoring, Applied to GI
Our medical monitors serve as the primary medical resource for investigators and study teams, ensuring adherence to eligibility criteria, participant safety, and data integrity with:
Eligibility review
Confirmation of inclusion/exclusion criteria to ensure the right participants are enrolled
Safety oversight
Continuous review of adverse events (AEs) and serious adverse events (SAEs) with timely follow-up to sites
Protocol guidance
Clarification on concomitant medications, prohibited therapies, and protocol deviations
24/7 availability
Continuous coverage to answer urgent medical questions from sites around the clock
Principal Medical Monitor and Team
Every study is assigned a principal medical monitor who leads the medical oversight services and is supported by a team of regional additional medical monitors to ensure global coverage through:
Collaborative oversight
We work closely with safety, clinical operations, and data management teams to identify trends and mitigate risks
Trend analysis
Regular medical data review to spot emerging safety signals or protocol compliance issues early
Documentation and Deliverables
We ensure that every medical decision is documented and audit-ready with:
Medical monitoring plan (MMP)
A comprehensive plan defining the scope of medical oversight, communication pathways, and escalation processes
Medical review logs
Formal documentation of eligibility inquiries, protocol deviations, and general medical questions
Training materials
Site training on protocol-specific medical eligibility and safety reporting requirements
