Aggregate Safety Assessment Planning

Consistently and Authoritatively
Communicating Your Safety Story

We are helping our clients consistently and authoritatively communicate their safety story in scientific evaluations and public disclosures.

Incorporate impact of FDA Medical Queries (FMQs) and Standard Safety Tables and Figures in submission plans
Be ready to comply with requirements for aggregate safety analysis and reporting

Leverage existing processes: Medical safety review of individual cases and medical monitoring of individual studies
Scientific evaluation of accumulating program-level safety information
- To support ongoing characterization of the product safety profile
- To prepare for regulatory filing activities and responses to regulatory queries

Leverage scientific expertise and medical judgment of multidisciplinary teams
Strategic planning: Aggregate Safety Assessment Planning (ASAP) process
Technical Implementation: Ongoing Aggregate Safety Evaluation (OASE)
- Part 1 (for learning): Overall safety assessment with descriptive statistics and graphical displays
- Part 2 (for decision-making): Safety Topics of Interest (STIs) are explored using more in-depth analyses and/or specific groupings of events that help to further characterize their occurrence

Consistent and authoritative communication of the safety story:

Safety profile of the product emerges: Development Core Safety Information and Investigators Brochure (DSUR, ISS, CTD…)
Iterative process of learning and decision-making continues: Company Core Safety Information and Product Label (RMP, PBRER…)

Ongoing aggregate safety assessments enable effective risk management