Aggregate Safety Assessment Planning
Consistently and Authoritatively
Communicating Your Safety Story
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.
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Business Challenges
Companies Need To...
- 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
Challenges Faced
- 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
Implementing the ASAP Process
Our Approach
- 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
Benefits and Outcomes
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
About Us
We help our clients to consistently and authoritatively communicate their safety story in scientific evaluations and public disclosures
TO PROVIDE for a scientific evaluation of accumulating program-level safety information throughout drug development, leveraging scientific expertise and medical judgment of the multidisciplinary safety management team
TO IMPROVE the overall quality of safety reporting and to comply with requirements for IND safety reports based on data in the aggregate
TO RESTORE a balance between open-ended discovery of potentially important context-dependent information and mathematical techniques for sorting the signal from the noise
Greg Ball, ASAP Expert
Greg has 36 years of strong leadership, managing people and projects; including 12 years as a traditional Statistician and 10 years as a Safety Statistician. He served in the Navy and taught high school math and physics before earning his MS in Statistics from Purdue and PhD in Biostatistics from the University of Texas.
Lead or senior author on 10 peer-reviewed scientific manuscripts on aggregate safety assessments
His research on blinded safety monitoring procedures is being developed in collaboration with statistical and clinical scientists at several pharmaceutical companies (including AbbVie and Merck).
Greg co-leads, with Mary Nilsson, the PhUSE Safety Analytics working group; he established, with Bill Wang, the ASA Biopharm Safety Monitoring working group and has been pioneering the joint DIA-ASA Interdisciplinary Safety Evaluation (DAISE) scientific working group, to advocate for aggregate safety assessments and cross-disciplinary scientific engagement.