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Embracing the Future: FDA’s New Draft Guidance on Decentralized Clinical Trials
Dive into the FDA's latest draft guidance on Decentralized Clinical Trials and the role of Risk-Based Quality Management.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
eyesON | Big Pharma M&As: Clinical Trials Data Visualization
Users can explore the impact of M&As on pharma companies, by examining how it affects their number of ran clinical trials, R&D spending, and share prices.
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 [...]
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.
Apr
2023
FDA releases updated guidelines for risk-based approaches to monitoring
FDA Guidance: A Risk-Based Approach to Monitoring of Clinical Investigations (Q&A) The FDA has published a new guidance document titled "A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Guidance for Industry," outlining their expectations for sponsors and clinical investigators regarding [...]
Mar
2023
eyesON | COVID-19: Global Impact on Clinical Trials
Wondering how the COVID-19 pandemic has impacted clinical trials worldwide? Explore the effects conveniently with our user-friendly data visualizer.