Valuable input on the clinical safety aspects of study designs, clinical trial safety issues and safety trend analysis.
Our dedicated medical monitors are expert physicians who closely monitor the study data for medical accuracy and identify trends that could potentially impact safety, including any adverse events of special interest (AESI) which warrant RMP and/or PV Safety Master File (PSMFs) updates and variations.
Their duties have been aided by our SAE Processing Model (EDC Design/Capabilities) which has reduced administrative burdens and has accelerated SAE Resolution and Closure. They can provide safety related advice on the protocol design of clinical trials, investigations, studies and Post-Market Clinical Follow-up (PMCF) of medicinal products, devices and combination products.
In addition to reviewing individual case safety reports (ICSR) for serious and non-serious events, our medical monitors:
- Evaluate individual medical events to verify that they meet clinical endpoints or adverse event criteria
- Collaborate on literature review and the production of aggregate safety reports (ASRs) and Reference Safety Information (RSI)
- Provide support for safety signal detection and safety risk management plans, and
- Provide consultation on clinical trial safety issues such as urgent safety measures (USM) and safety management plans (SMPs).