Although relatively rare, clinical investigator inspections by the U.S. Food and Drug Administration (FDA) can have a significant business impact. Audits are conducted more frequently than regulatory inspections, which are […]
Many times, individuals who have triumphed over frightening, or even near-death, situations will say that the experience has given them a new and more positive outlook on life. Allison Massari, a two-time survivor of such scenarios, has an additional and unique insight—and it’s on the patient experience. She celebrates how healthcare professionals have an “exceptional power to transform lives,” and will share her perspective on how compassionate care can be incorporated into clinical research in a Signature Series keynote session tailored for attendees of ACRP 2025 in New Orleans, La., in April.
If there’s one thing clinical researchers can count on when it comes to regulations and guidance from governing bodies, it’s change. In Q4 of 2024 alone, new guidance documents were drafted or finalized on a number of topics.
People who are entering the clinical research profession can come from many other fields and with very diverse backgrounds. No matter their role, everyone acknowledges project management as an essential and invaluable skill set. Project management requires leadership, communication and management skills that can be applied in any role across clinical research.
The ICH E6(R3) guideline for Good Clinical Practice (GCP) was adopted by regulatory members of the ICH Assembly on January 6, 2025. The final version of the updated guideline, which aims to foster a culture of quality as technologies and methods evolve, is now recommended for adoption by regulatory authorities in ICH regions, which include the U.S., Europe, and Japan.