White Paper

Risk Based Quality Management (RBQM) - A Collaborative Approach To Holistic Clinical Trial Oversight

By ACRO’s CRO Forum’s RBQM Working Group

data technology in hands 450x300

Developing, executing, and overseeing clinical trials is a complex process. Gaining reliable evidence from clinical trials is essential for appropriate decision-making activities regarding trial participants’ safety and the reliability of trial results. As clinical trials have become more complex, the clinical trial process has faced significant operational challenges. As a result, sponsors must identify proactive ways to design quality into the study design rather than taking the reactionary approach of monitoring quality into clinical trials. Risk Based Quality Management (RBQM) rooted in Quality by Design (QbD) principals while applying Risk Based Monitoring (RBM) control mechanisms offers such a solution. This systems-wide approach encourages cross-functional engagement in a holistic and risk-based approach to clinical trial management and oversight. Ultimately it will be that framework which supports key decisions that will manage clinical trial complexity.

VIEW THE WHITE PAPER!
Signing up provides unlimited access to:
Signing up provides unlimited access to:
  • Trend and Leadership Articles
  • Case Studies
  • Extensive Product Database
  • Premium Content
HELLO. PLEASE LOG IN. X

Not yet a member of Cell & Gene? Register today.

ACCOUNT SIGN UP X
Please fill in your account details
Login Information
I'm interested in newsletter subscriptions.
ACCOUNT SIGN UP

Subscriptions

Sign up for the newsletter that brings you the industry's latest news, technologies, trends and products.

You might also want to: