Meghan Hosely

Data safety monitoring boards (DSMBs) ensure research participants are protected and results are valid. Learn about DSMB composition, concerns, charter, and challenges.

Key strategies for successful research study startup: site selection, documentation, and effective initiation.

Discover how CTMS streamlines patient recruitment & management for successful clinical trials.

FDA recently released new guidance, potentially impacting early-phase cell and gene therapy trials.

Sickle cell disease significantly impacts the African American population, a minority community historically underserved by clinical research.

Recent signals have indicated the FDA plans to provide greater support for cell and gene therapy research.

Until the 1980s, children were excluded from research studies. Now, FDA provides draft guidance on ethically including kids in trials.

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.