Has anything really changed in Clinical Quality? My amazing Quality career has spanned from before the mainstream use of PC’s to today's sophisticated electronic measures, quality data analytics and wearable audit tools. I have also worked alongside some of the most dedicated and amazing people I could ever hope to know. But… has it really changed anything? For many years, I would see the same findings over and over again. Has it changed? Do we have progress?
Well, I think we are seeing progress, and I feel positive for the future, driven by some of the following shifts and changes:
- The introduction of Clinical Quality Management Systems (QMS) with a focus on Quality by Design, Risk-based approaches and Management Quality Reviews, etc.
- Some great new global regulations, such as ICH E6 (R2). (I love regulations!)
- External groups, such as TransCelerate BioPharma Inc., the Clinical Trials Transformation Initiative (CTTI), and many other innovative groups, which are allowing us to see and think about our collective data in new ways.
- The advent of Risk-Based Monitoring (RBM), Central Monitoring and powerful data analytical tools.
- Data transparency, patient advocacy groups, and real world evidence, all directionally moving us towards better clinical trial outcomes.
So, what’s next? Continued fine tuning of the new Clinical Quality Management System approach is critical, and then a look to the future where I believe there are opportunities to rethink how we establish and manage Clinical Quality functions and weave them more closely into the operational business.
About the Author: Jane Wood is the Principal of YourEncore's Quality Center of Excellence. With over 40 years global experience, Jane has led small and large teams of Quality professionals to mitigate risk and develop R&D Quality solutions. Jane currently leads a team of subject matter experts offering in-depth experience in all sections of Quality and GxP.