Since the release of ICH GCP E6 R2 Addendum, there is a large confusion in the pharma industry, what is the difference between Quality Tolerance Limits (QTLs) and Key Risk Indicators (KRIs). The ICH stated: Predefined quality tolerance limits should be established, taking into consideration [...]
If you are thinking about joining a clinical research study, then you might wonder about the safety risks you should be aware of, as no clinical trial is completely safe for everyone.
Pharma today embraces the concept of patient-centered research. Innovators view Patients as informed collaborators whose participation is core to the overall success of clinical research. The risk-based Patient Profiles tool is a key contributor to the modern concept of patient-centered thinking, as It enables early detection and real time control of patient safety issues.
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.
Adverse Event (AE) reporting, identified by the FDA as one of the most important challenges in clinical research, is known to be prone to under and over-reporting. When starting a project and considering the various ways available to capture the adverse event data, it’s important to ask yourself some analytical questions that help you improve AE and SAE capturing and reporting.
The dramatic expansion of prescription drug deaths inspired this year's theme "driving insights to action". Insights that could be deployed through novel disruptive technologies such as Risk-based Quality Management (RBQM). Cyntegrity's Johann Proeve and Nimita Limaye were in Boston and share their observations with us.
The EU MDR is setting the stage for busy times ahead. The continuous need for clinical evidence, the increasing complexity of new medical devices, and the size and global nature of medical device trials introduce a greater potential for error. Learn how a risk-based approach enables MedTech manufacturers to better understand, manage and mitigate the growing uncertainties.
By design, the traditional spot-checking type of audits leave a blind spot on systemic quality threats. Key Risk Indicators however, form the core of a widely applicable concept that captures all relevant risks in scope and provides project managers and QM experts targeted and objective updates on actionable issues and trends.
Many risks in clinical trials seem therapy specific. To illustrate this, Dr Johann Proeve shares real life use cases he experienced during his years as Head of Global Data Management at Bayer HealthCare.
Many risks in clinical trials are therapy specific. Because of that, the currently available tools addressing those risks are now becoming therapy specific as well. The first therapy focused risk library Oncology RACT (OncoRACT) recently got available.
