MEDICAL MONITORING
We have licensed medical doctors responsible for the medical and scientific oversight of a clinical trial. They ensure the safety of participants, adherence to the study protocol, and accurate reporting of adverse events.
Medical Oversight and Safety Monitoring
Review of Adverse Events (AEs), SAEs, and SUSARs
Ensuring accurate assessment of causality, seriousness, and expectedness.
Providing medical narratives and opinions to support safety reporting
Ongoing Safety Surveillance
Trends and signal evaluation.
Protocol deviation assessments from a safety perspective.
Protocol and Study Design Support
Participating in protocol development, including eligibility criteria, safety endpoints, and stopping rules.
Reviewing and approving investigator brochures, informed consent forms, and case report forms (CRFs).
Medical Queries & Site Support
Responding to medical questions from investigators and study staff.
Providing real-time medical guidance during study conduct (24/7 availability often required).
Medical Data Review
Reviewing listings, lab values, ECGs, and efficacy assessments.
Collaborating with biostatistics and data management to ensure data accuracy.
Regulatory and Ethics Support
Contributing to DSMB/IDMC meetings.
Providing input into safety sections of regulatory submissions (e.g., IND, NDA, PSURs).
Assisting in safety responses to ethics committees and regulatory authorities.