The growing focus on post-marketing and observational research has brought a heightened awareness, and scrutiny, on the design and execution of these studies. There are some that feel that only a randomized clinical trial can produce robust study results that are scientifically sound and provide relevant data for sponsors and regulatory authorities. Within this podcast we will explore the scientific integrity of post-marketing and observational research, and how these studies can provide important information that can complement your early phase clinical trial results.
Advocacy Groups in Patient-Focused Drug Development
THE INSIGHT SERIES: Why do prescribers participate? - Part III
While Phase II-III studies include small datasets, comprising several hundred to several thousand patients, they provide the data necessary for drug…
Challenging Study Timeline Goals Achieved in Global Post-Authorization Safety Study (PASS)
PRA Health Sciences Late Phase Services is participating in a global real world safety study program, mandated by various regulatory bodies, to…