Training Implications of the ICH E6(R3) and E8(R1) Guidelines
Be prepared for ICH E6(R3): turn guidelines into real-world action. In this post, we delve into the key updates and training gaps.
May 2023
May 2023
A Comparative Review of the ICH E6(R3) and E8(R1) Guidelines
Unpacking the new ICH guidelines, E6(R3) and E8(R1), we illuminate their key elements, identify gaps, and compare the two in terms of their unity, differences, and complementarity.
May 2023
Embracing the Future: FDA’s New Draft Guidance on Decentralized Clinical Trials
Dive into the FDA's latest draft guidance on Decentralized Clinical Trials and the role of Risk-Based Quality Management. Learn how RBQM and centralized monitoring can elevate your clinical research efficiency and reliability.
May 2023
Big Pharma M&As: Is It Worth the Trouble?
Big Pharma M&As: A Worthwhile Challenge? Navigating the complex landscape of M&As in the pharmaceutical industry comes with unique objectives and potential benefits. But do these transactions truly drive shareholder value for the acquiring firm?
May 2023
Enhancing R&D Due Diligence in Pharma M&As: The Role of MyRBQM Portal
Navigate your M&A journey confidently with Cyntegrity's MyRBQM Portal. Aspiring to hit your targets within 6-12 months? Discover how we can make it possible in R&D due diligence.
Apr 2023
Global Impact of COVID-19 Pandemic on Clinical Trials
Wondering how the COVID-19 pandemic has impacted clinical trials worldwide? The COVID-19 pandemic has brought unprecedented challenges to the healthcare industry worldwide. The clinical trial sector has been no exception, and it has undergone significant changes over the past few years. From the [...]
Mar 2023
Synergy of QbD, RBM, and RBQM in Trials
Clinical trials require a comprehensive approach to ensure quality and efficiency. Quality by Design, Risk-Based Monitoring, and Risk-Based Quality Management work together to achieve these goals, focusing on building quality into the trial process, targeting monitoring activities, and continuously improving trial quality.
Mar 2023
Patient Safety in Clinical Trials
What is the future of patient safety in clinical trials? The life sciences industry is experiencing an evolution. Technology is forcing digital transformation and is rapidly changing the way that companies conduct research, test treatments, and evaluate data. To continue this progress, industry experts [...]
Mar 2023
Why the Industry Finds It Easier to Embrace Key Risk Indicators than Quality Tolerance Limits
This opinion piece by Keith Dorricott, MBB, addresses the challenges faced by the clinical trial industry in implementing QTLs and KRIs as required by ICH E6(R2). The article explores why KRIs have been easier to adopt than QTLs and wonders if the specific guidance provided by ICH E6(R2) is partly responsible.
Mar 2023
What’s the Difference Between RBQM and QRM in Clinical Trials?
In clinical trials, managing risks that could impact data quality is crucial for ensuring patient safety, data integrity, and regulatory compliance. While Risk-Based Quality Management (RBQM) and Quality Risk Management (QRM) are both approaches designed to manage risks, the two have essential differences.