Rethinking Clinical Trials

FEBRUARY 7, 2024

Winckler, RPh, Esq Chief Executive Officer Reagan-Udall Foundation for the FDA Slides Keywords U.S. Food and Drug Administration, FDA, Misinformation, Communication, Health Information Key Points U.S. Sound science, sound policy, and sound communication are each fundamental to the Agency’s success.

Regulation 152

Regulation Production Clinical Trials Clinical Trials 152

Rethinking Clinical Trials

JUNE 29, 2022

Center for Drug Evaluation and Research (CDER). Food and Drug Administration (FDA). Big data; Real-word evidence; Real-world data; 21st Century Cures Act; FDA Draft Guidance. and the FDA Draft Guidance for RWD/RWE. Office of Medical Policy (OMP). Key Points. Discussion Themes. pctGR, @Collaboratory1.

Big Data 130

Big Data Clinical Trials Clinical Trials Drugs 130

Rethinking Clinical Trials

JULY 6, 2023

The Food and Drug Administration (FDA) issued a draft guidance in May 2023 that provided guidance about the conduct of decentralized clinical trials. The Food and Drug Administration (FDA) issued a draft guidance in May 2023 that provided guidance about the conduct of decentralized clinical trials.

Trials 130

Trials Clinical Trials Clinical Trials Licensing 130

Rethinking Clinical Trials

AUGUST 28, 2023

 Speakers Prof Sir Martin Landray, FMedSci Professor of Medicine & Epidemiology University of Oxford Chief Executive, Protas Khair ElZarrad, PhD, MPH Director, Office of Medical Policy Center for Drug Evaluation and Research (CDER) U.S. The new structure aims to provide clarity and better readability.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Development 130

Rethinking Clinical Trials

AUGUST 28, 2023

 Speakers Prof Sir Martin Landray, FMedSci Professor of Medicine & Epidemiology University of Oxford Chief Executive, Protas Khair ElZarrad, PhD, MPH Director, Office of Medical Policy Center for Drug Evaluation and Research (CDER) U.S. The new structure aims to provide clarity and better readability.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Development 130

Crucial Data Soutions

JULY 23, 2019

What’s the keyword in informed consent? During study design in TrialKit, administrators enable permission levels for users – this includes access to informed consent data. Today’s technology makes it possible for trial participants to consent from virtually any location and have that consent tied directly to their own data.

Clinical Trials 40

Clinical Trials Clinical Trials Trials Clinical Research 40