Our Approach
Aggregate Safety Assessment Planning (ASAP) Process
1. Planning
Proactive and systematic planning for program-level, ongoing aggregate safety assessments
- Across ongoing and completed trials throughout product development
- Strengthen cross-disciplinary communication and collaboration
- Leverage existing safety monitoring processes
2. Learning and Decision-making
To enhance the ongoing understanding and characterization of the product safety profile
- Prioritization of safety topics of interest, pooling strategy, and characterization of emerging safety profile
- Planning and execution for ongoing aggregate monitoring (including for blinded trials), focused on these topics
3. Communication
Preparation for regulatory filing activities and responses to regulatory queries
- Consistent and authoritative communication of the safety story in scientific evaluations and public disclosures
Strategic Planning: ASAP Process
(guides the technical implementation)
- Safety topics of interest: Consistent definitions across studies in the program
- Pooling strategy: General patient population and special populations of interest
Technical Implementation: Blinded-OASE
- To evaluate the general safety profile of the product (without unblinding)
- To detect emerging safety topics while studies are ongoing
- To evaluate risk elevation for select safety topics of interest
Technical Implementation:
Unblinded-OASE
- To support ongoing characterization of the product safety profile
- To leverage the results for planning and preparation of aggregate safety-related documents in support of a regulatory filing
- To support responses to health authority requests related to specific safety inquiries
What We Can Do
Strategic Planning
- Aggregate Safety Assessment Planning (ASAP) document (and updates)
- Safety Surveillance Plan (SSP): For the IND safety reporting final rule
- Quantitative blinded safety monitoring procedures
Technical Implementation
- Ongoing Aggregate Safety Evaluation (OASE) Plans
- Safety Tables and Figures
- Safety Assessment Reports
Form the Safety Management Team (SMT)
To plan and coordinate aggregate assessments of accumulating safety data across ongoing and completed trials throughout the product development life cycle
Support the DMC or another Entity
(an individual or group of individuals)
To review the accumulating safety information in a program (for IND reporting)
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.