Join us for an insightful webinar highlighting how Risk-Based Quality Management (RBQM) can empower M&A and investment decisions in the pharmaceutical industry. Discover how RBQM enhances clinical due diligence processes, supporting areas like data integrity and risk assessment. We’ll explore methodologies and potential findings that drive data-driven decision-making, ultimately showcasing the benefits of gaining actionable […]

We will share an example of output that a central monitor might see and work together to investigate to determine if there is an issue and then try to determine the root causes. We will use the D-I-G-R root cause analysis method and show how it is more effective than the overly simplified „Five Whys.“ […]

Some companies have been early adopters of RBQM methodology, and others have been laggards. What evidence is there of added value to the early adopters? ABOUT „mindsON RBQM“ WORKSHOPS mindsON RBQM is a series of workshops that provides practical advice on the challenging aspects of an RBQM roll-out and its daily execution. Each workshop allows […]

We will share a simplified example of a protocol outline, along with high-risk items that we want to reduce. How would you define KRIs to monitor the high-risk items? How would you determine the metric definition and thresholds? Will you get the same answers as our RBQM experts? Come along to take part – or […]

We will share a simplified example of a protocol outline, along with high-risk items that we want to reduce. How should you go about reducing risks? What is a mitigation, a risk control and a contingency? Will you get the same answers as our RBQM experts? Come along to take part – or just listen […]

We will share a simplified example of a protocol outline, brainstorm, and evaluate risks. Will you get the same answers as our RBQM experts? Come along to take part—or just listen and learn. ABOUT „mindsON RBQM“ WORKSHOPS mindsON RBQM is a series of workshops that provides practical advice on the challenging aspects of an RBQM […]

Join us for a quantitative exploration of risk-based clinical trials, a game-changer in Clinical Trial Risk Management. Throughout this webinar, we’ll demonstrate how applying a risk-based approach can help save remarkably in different areas such as Risk Management Study Conduct, Operational Efficiency, SDV Reduction, and Protocol Amendments, leading to an average savings of $2.8M per […]

An area of much debate (and confusion) is the differences, similarities, and overlaps between Risk-Based Quality Management, Quality by Design, Centralized Monitoring, Centralized Statistical Monitoring, Remote Monitoring, and Risk-Based Monitoring. Or, in the alphabet soup of our industry, RBQM, QbD, CM, CSM, RM and RBM. At this workshop, our industry experts will provide their perspectives […]

As generated by ChatGPT: „Are you ready to revolutionize your Risk-Based Quality Management (RBQM) practices? Don’t miss our upcoming webinar, where we will explore the incredible potential of Artificial Intelligence (AI) in RBQM and how it can drive efficiency and ensure patient safety. During this dynamic session, our industry experts will explore the applications, benefits, […]

The guideline for Good Clinical Practices, ICH E6 (R3) draft, and ICH E8 (R1) introduce Critical to Quality (CTQ) Factors. What are they? How should they be used as part of RBQM? And whatever happened to critical processes and critical data? ABOUT „mindsON RBQM“ WORKSHOPS mindsON RBQM is a series of workshops by Cyntegrity’s MyRBQM […]