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Embracing the Future: FDA’s New Draft Guidance on Decentralized Clinical Trials
Dive into the FDA's latest draft guidance on Decentralized Clinical Trials and the role of Risk-Based Quality Management.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
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
Cyntegrity Unveils Online Learning: Empowering Clinical Trial Professionals
We're excited to announce the launch of Cyntegrity's new online learning platform, MyRBQM Academy. As a pioneer in providing intelligent RBQM technology solutions, we believe that education is the first step in transitioning to a new way of working in clinical research.
Mar 2023
Revolutionizing Clinical Data Management in the US: A Look at the Past, Present, and Future
Discover how clinical data management in the US has transformed from data collection to a multi-faceted endeavor, driving breakthroughs in biomedical research, diagnostics, drug development, and vaccines. Learn from leading experts, including our Chief Scientific Officer, about the latest advancements and future prospects in this groundbreaking publication.
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
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
eyesON | Clinical Trials Global & Regional Insights Visualized
Explore clinical trial and enrollment activity across countries with ease. Our new eyesON application visualizes data from ClinicalTrials.gov, helping you gain a deeper understanding.
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.