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.
Checking and maintaining trial integrity, and proactively adjusting trial analysis strategies to ensure trial data validity, are the FDA's two key areas of concern.
The workshop at Robert J. Margolis Center for Health Policy at Duke University was to capture stakeholder input on the challenges, barriers, and enablers to implementation of Risk-Based Monitoring (RBM). The workshop also reviewed stakeholder experiences with RBM adoption and opportunities to improve [...]
Predictive Analytics is seen as the next generation methodology: “growing across most therapy areas in the coming years”. Pharma companies and CROs that embrace next generation analytics will position themselves for immeasurable competitive edge in the industry.
Regulatory bodies are unanimous, today's clinical research needs Centralized Monitoring. We summarized Centralized Monitoring the infographic way, download your free copy here...
Neat Features: wanting to dig a little deeper into the neat software features that make your risk-management life easy? Well, you’ve come to the right place. Learn more about Risk Flowers charts - a bunch of information.
To clear up confusion surrounding the interpretation and use of QTLs and KRIs, we have created an easy to understand infographic for all clinical research experts involved in quality control.
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.
Zooming in on three key areas; analytics-driven feasibility, patient-centric enrolment planning and Risk-based Monitoring, SCOPE Europe professionally facilitated high level discussions between pharma industry leaders and decision makers.