Post-approval safety studies (PASS)
A post-approval safety study (PASS), also known as a post-marketing safety study or post-market surveillance study, is a type of clinical study or research initiative conducted after a medical product, such as a drug, medical device, or vaccine, has received regulatory approval and is available on the market for use by the general population.
These studies are designed to monitor the safety profile of the product in real world clinical settings and assess any potential adverse effects or safety concerns that may not have been fully identified during pre-market clinical trials.
Why is Cisiv’s technology ideal for PASS?
- An integrated safety module
- A flexible and scalable model for long-term studies
- The ability to analyse data by cohort
- Tools to engage physicians and patients for retention strategy
- Compliance with global regulatory requirements – enables submission to FDA and EMA
- Integration with pharmacovigilance ways of working
Find out more about Cisiv’s work with PASS in our recent case study.
To learn more about PASS and Cisiv technology, contact us here.
