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.
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.
IDC MarketScape Mentions Cyntegrity in RBQM Vendor Report
IDC MarketScape has listed Cyntegrity as one of the top 8 RBQM vendors in its "Worldwide Life Science R&D Risk-Based Monitoring Solutions 2022 Vendor Assessment" study.
AI-Augmented RBQM Solutions for Clinical Trials | Cyntegrity
CELEBRATING 10 YEARS OF ADVANCING CLINICAL TRIALS AI-Augmented RBQM Solutions Cyntegrity's suite of integrated solutions enhances operational efficiency with end-to-end risk-based quality management. Talk to an Expert Cost-reduction in ClinOps [...]
Quality by Design | ICH E8(R1) General Considerations for Clinical Studies
The final version of the ICH E8(R1) guidance discourages the old-school "one size fits all" approach. Instead, risk-based quality management concepts such as QbD and CtQ factors predominate these modern-day considerations which encourage the biopharma industry to go beyond the traditional checklists. We've visualized the final 2021 guidance, "General Considerations for Clinical Studies," for you.
7 Most Important QTLs for Clinical Trials
Within the bounds of risk-based quality management, the utilization of predefined Quality Tolerance Limits (QTLs) is a way to control quality and risk in clinical trials. QTLs identify systematic risks to patients and data integrity at the study level. We've listed the 7 most commonly used QTLs that are applicable to most trials.
What is Risk-Based Quality Management?
“RBQM is the next RBM” - FDA “The Risk-Based Quality Management concept is the whole system not just the last component of monitoring” began his speech on July 17, 2019 the FDA’s Director David Burrow in the Robert J. Margolis Center for Health Policy [...]
Data Integration – A Valid Concern or a Convenient Excuse?
Conference season has started! Our first stop was the Global RBM Summit 2018 in London. Our CSO Dr Johann Proeve was invited to join the conversation as a speaker on the topic “Pragmatic Centralized Monitoring – How to get there?”. Johann shares his observations with us.
What is the Cost of Poor Quality in Pharma?
Quality is a business decision. Everyone instinctively knows that poor quality doesn't come cheap, however until now no attempt was made to calculate the real difference between good and poor quality in clinical trials. Most of the issues that impact cost and expenses are lurking just below the tip of the iceberg.
How to master the new EU Clinical Trials Regulation with RBM?
EPharma day Munich - RBM with EU Clinical Trials Regulation from Artem Andrianov (originally presented by Artem Andrianov on German EPharma Day) The new EU Clinical Trials Regulation (CTR) becomes applicable already on 28th of May 2016. It introduces a number of major changes in [...]