Clinical Trial Safety
We provide medical safety support across early- and late-stage clinical development, including First-in-Human, Phase I, Phase II, Phase III and Phase IV programmes. Experience includes medical safety support for large cardiovascular outcome trials involving approximately 6000-7000 patients.
Services include:
- Development of clinical safety strategies
- Medical review of safety sections of study protocols and informed consent forms
- Advice on eligibility criteria, safety monitoring, stopping rules and other risk control measures
- Development and review of safety monitoring plans
- Study- and programme-level safety surveillance
- Cumulative safety data reviews and integrated safety assessments
- Identification and characterisation of important potential risks
- Medical input into Reference Safety Information and Development Core Safety Information
- Support for Independent Data Monitoring Committees and event-adjudication committees
- Development and review of IDMC and adjudication committee charters
- Medical input into investigator meetings and clinical study reports
- Assessment and implementation of Urgent Safety Measures
- Preparation of Dear Investigator Letters and safety-related protocol or informed-consent amendments
- Communication with investigators, ethics committees and health authorities on emerging safety matters