What is a Safety Assessment Committee (SAC) Program?
Safety Assessment Committees are recommended by the FDA (through its Drug Safety Guidance for Industry) to oversee and report on patient safety data throughout a drug’s development program. The intended impact is to improve patient safety through a more structured safety assessment and reporting system for all investigational new drugs (IND).
Why use a Safety Assessment Committee?
The FDA guidance states that due to the critical need to detect and report serious adverse events as early as possible, sponsors should form a Safety Assessment Committee and a safety surveillance plan as “key elements of a systematic approach to safety surveillance.”
The recommended composition of a Safety Assessment Committee is:
- At least one physician familiar with the therapeutic area of the investigational drug
- Clinicians with general or specific safety experience (e.g., cardiology, neurology)
- Qualified by safety assessment training and experience
- Available to review safety information on a regular or ad hoc basis
- Comprised of fully independent, external members, sponsor members, or a hybrid, as needed
While the SAC is “distinct from a DMC”, a DMC’s expertise and reports can be used to facilitate operations of the SAC.
What benefits have clients realized from using ACI’s SAC solutions?
Our SAC solutions have helped clients:
- Establish expected event thresholds
- Make smarter decision-making based on streamlined reporting
- Create effective safety reporting mechanisms that mitigate risks and prevent resource waste
- Catch safety issues early on
- Assess and mitigate risk with findings
- Bolster regulatory strategy prior to submission
Why use ACI’s Safety Assessment Committees?
ACI Clinical’s safety and committee experts can help you navigate the new safety reporting requirements and develop a Safety Assessment Committee solution tailored to your unique drug development needs. We will ensure that you leverage efficiencies with your DMCs while retaining the necessary separations/firewalls between the two.
Our SAC’s are supported by staff with deep industry/regulatory expertise and a technology platform that enables seamless data sharing, collaboration and decision-making.
Send us a few details on your project so we can partner on an optimal Safety Assessment Committee for your clinical development program.