Does Risk-Based Quality Management (RBQM) Actually Improve Quality?

Clinical Researcher

Is risk-based quality management working? Is it supporting the primary mission of improving quality in clinical trials? To answer these questions, we need to understand the limitations of traditional approaches to quality and explore the latest evidence which demonstrates how the components of centralized monitoring are helping to find the errors that matter.

The Evolution of Access: A Pathway to Multiple Markets

Clinical Researcher

As companies seek ways to bring their products to multiple markets, understanding those markets and their regulatory approval process is imperative. Choosing the most appropriate pathway can reduce the burden on both the sponsor and on the health authorities, and potentially expand access to more patients. One such pathway is the Access Consortium, which was formed in 2007 by four health authorities.

Clinical Development of Preventive Antimicrobials

Clinical Researcher

Preventive antimicrobials are a promising solution to the antibiotic resistance problem, driven in part by recent advances in cell engineering technology and the important safety advantages of biologic drugs over their small-molecule cousins. However, not all of the barriers to wider adoption are scientific or biological—this novel therapeutic modality has important clinical, regulatory, and patient recruitment implications.

ACRP Journal Article Focuses on Clinical Research in Transgender and Gender Diverse Populations

Blog

Just in time to help recognize Pride Month, ACRP’s Clinical Researcher journal is pleased to share the first details from the lead peer-reviewed article on “Improving Cardiovascular Research for Transgender and Gender Diverse Populations” from a trio of WCG IRB expert contributors to the June issue. The article bolsters the issue’s “Let’s Get Personal: Scaling Clinical Research Down to You and Me” theme as it joins several other contributed pieces focused on patient centricity and personalized or precision medicine topics.