Regulatory

The joint pilot will test the use of a single eSTAR, an interactive form that guides applicants through the process of preparing FDA medical device submissions.

The hope is to build a formal framework for using digital health technology in clinical trials in Europe and beyond.

Benefits of business 4.0 approach in EDC in med-dev studies.

Shiri Diskin, PhD, Head of Medical Writing at Bioforum, sits down with Daphna Laifenfeld, PhD, Chief Scientific Officer at Ibex Medical Analytics to discuss the challenges associated with developing a CER and how to effectively navigate them while creating opportunities that increase efficiencies.