Opportunities
Framework for Interdisciplinary Safety Evaluation
Engages critical team members
Team can best identify potential safety signals and evaluate them for causal association when it is comprised of safety clinicians and data scientists
Supports the iterative nature of the process
- 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…)
Recognizes advantages and availability of various data sources over time
Data sources and methodologies in flux require a dynamic interdisciplinary approach and an evolution in understanding
Over 20 Years of Aggregate Safety Expertise.
We are helping our clients consistently and authoritatively communicate their safety story in scientific evaluations and public disclosures.