Generic drugs play a critical role in improving patient access and reducing healthcare costs. But bringing a generic to market is not a simple process. Companies must demonstrate that their...

The goal of an NDA application is to present a clear, defensible story across CMC, nonclinical, clinical, and labeling so reviewers can evaluate benefit and risk without searching for...

If you’re developing a new medical device and there’s no clear predicate on the market, you may be wondering whether the FDA’s De Novo pathway is the right route forward. The process can...

Launching a clinical trial outside the United States requires more than a strong protocol. It requires regulatory approval in the form of a Clinical Trial Application (CTA).

What is 21 CFR Part 11?

21 CFR Part 11 is a regulation established by the U.S. Food and Drug Administration (FDA) that sets the criteria for electronic records and electronic signatures...

One of the more challenging aspects of clinical trial management is visibility. The sheer number of outsourced partners - sites, CROs, writers, consultants, vendors, etc - who often have...

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, or simply ICH, stands as a cornerstone in the realm of pharmaceutical development...

For many small and mid-size Clinical teams, the TMF struggle is real. Maybe you’re using your CRO’s eTMF for now - but what happens after study completion? Or maybe you’re trying to save...

At the heart of clinical trial documentation lies the Trial Master File (TMF), a comprehensive repository of essential documents and data pertaining to the trial. Let’s discuss this...

Today's clinical trials are partnerships, between Sponsors, CROs, and other vendors. These collaborations enable small organizations to do more, but it also presents challenges. In this...

Happy new year folks!