Despite rapid growth, only 9.2% of DCTs are multiregional and over 80% single-country, indicating challenges in international implementation. 2 With regulatory agencies 4–7 underscoring risk-based ...

The FDA today announced a new initiative to allow its reviewers to access information from clinical trials in real time, with two major industry players already taking part in a pilot program.

The Libraries provide guidance for writing Data Management (and Sharing) Plans (DMPs or DMSPs), whether they are required as part of a grant proposal or written electively to support effective ...