ACRP blog

SEPTEMBER 11, 2023

Overview Decentralized clinical trials (DCTs) represent the shift towards implementing virtual research studies using digital health tools to gather data and monitor patient activity. During the COVID-19 pandemic, the clinical industry experienced significant disruption to traditional practices.

Clinical Trials 69

Clinical Trials Clinical Trials Trials Drugs 69

Advarra

DECEMBER 15, 2022

As the research community continues to seek clinical trial efficiencies designed to bring therapies to patients faster, more governing bodies are pushing for single institutional review board (single IRB) review as one way to streamline efforts. This blog provides a beginner’s overview of single IRB review in the U.S.

Clinical Trials 52

Clinical Trials Clinical Trials Regulation Research 52

FDA Law Blog

SEPTEMBER 20, 2021

From new initiatives to facilitate faster reviews for new indications under the Split Real Time Application Review (STAR) pilot program, to bringing new meetings under PDUFA goals, to continued support for rare diseases and incorporation of the patient voice, the goals letter revealed a good number of welcome announcements.

Development 52

Development Gene Therapy Production Drugs 52

FDA Law Blog

MARCH 2, 2022

Shapiro — We return to the subject of FDA’s role in effectively blocking most rapid antigen COVID tests from the U.S. NIH has been in communication with FDA to finalize a standardized clinical protocol for this purpose. To explain: Nearly all COVID-19 in-vitro diagnostic trials are single point analyses.

In-Vitro 40

In-Vitro Trials Marketing Development 40