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