Medical Review of Individual Case Safety Reports
We provide physician-led medical review of Individual Case Safety Reports from clinical trials and post-marketing sources.
Services include:
- Assessment of clinical information, diagnosis and medical plausibility
- Evaluation of coding, seriousness, expectedness, causality and narrative
- Review of temporal relationships, dechallenge, rechallenge, alternative explanations and relevant risk factors
- Preparation of clear and medically substantiated company medical assessments
- Medical oversight of complex, serious or otherwise clinically significant cases
- Identification and assessment of suspected unexpected serious adverse reactions
- Support for expedited regulatory reporting decisions
- Medical evaluation of IND Safety Reports
- Preparation and review of Analyses of Similar Events
- Identification of clinically relevant follow-up questions
- Resolution of medical queries with the Pharmacovigilance and Clinical Operations teams
- Use of individual case data to support signal detection and cumulative risk assessment
We are familiar with global safety databases, including Oracle Argus Safety and ARISg, and apply relevant clinical-trial and post-marketing pharmacovigilance requirements to each case assessment.