Meghan Hosely

FDA released regulations in 1997 outlining how 21 CFR Part 11 applies to electronic records and electronic signatures in clinical research.

By 1983, only 38 orphan drugs received FDA approval. Since then, the FDA has significantly changed its approach to rare and orphan diseases.

Sponsors are uncertain about how to design a DCT to ensure efficient performance delivery, learn how to set your organization up for success.

New FDA guidance (ICH q12) applies to pharmaceutical drug substances and products requiring a marketing authorization.

While the IND application process may be straightforward to some, we explore the most common pitfalls as sponsors prepare for submission.

This blog provides a beginner’s overview of what the pre-IND meeting is and how to prepare for one.

The 2022 Onsemble Conference provided an opportunity for attendees to reconnect in person and collaborate to move research forward.

Advarra's Sergio Armani introduces ACRP's Ride for Diversity program and why it's important to him personally and to the research community.

Ensuring proper compliance within clinical trials is confusing, so here are best practices to ensure charges and claims are correctly routed