Support Post-marketing Surveillance Efforts

The Vioxx^® controversy brought home the importance of post-marketing surveillance for many of us. It made everyone – not just drug development professionals – aware of the importance of monitoring the safety of new drugs even after Food and Drug Administration (FDA) approval.

Monitoring a new drug once it’s more widely available makes sense for everyone involved. It can help confirm, refine, or deny the safety of the product. However, there are unique challenges associated with this kind of effort. Once a new drug is out in the market, the controlled environment of the clinical trial and the relatively small number of subjects are no longer part of the equation. Fortunately, the latest online technologies can make it easier to monitor consumers on a much larger scale.

Patient-reported outcomes (PRO), like the SF-36v2^® Health Survey and the SF-12v2^® Health Survey, are becoming a bigger part of post-marketing surveillance because of the tools' ability to measure and track the health status of individuals and groups over time – a key feature for health registry developers. QualityMetric makes this possible with our Smart Measurement System. This system completely elminates the manual labor needed to collect data, and the months needed to score and analyze the results.

To learn more about how we can help with your post-marketing efforts, please contact David Parrillo.