This special edition of mindsON focuses on Risk Management and effective Sponsor Oversight in Clinical Trials. Our experts, guest speaker Jessica Cordes (Clinical Excellence GmbH, Clinical Operations Expert) and Dr. Johann Proeve (Cyntegrity, Chief Scientific Officer), provide practical insights into how a strategic oversight and risk management framework can help Weiterlesen…
Join us for this special edition of mindsON, focused on the expanding role of Medical Monitoring in clinical trials. With the upcoming release of ICH E6(R3) guidelines, trial oversight professionals now encounter fresh requirements in risk management, patient safety, and data quality. This session will explore how these guidelines shape Weiterlesen…
Proud and pleased, we at Cyntegrity’s MyRBQM Academy celebrate another milestone: Our five-year anniversary of transferring RBQM knowledge and expertise! We’re grateful for the 1,630 participants from 385 organizations who have trusted us with their RBQM goals. To show our appreciation, we’ll grant all learners a 50% DISCOUNT on our Weiterlesen…
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 Weiterlesen…
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 Weiterlesen…
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 Weiterlesen…
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 Weiterlesen…
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 Weiterlesen…
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 Weiterlesen…
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 Weiterlesen…