The updates of ICH E8 and E6 represent a shift in the conduct of clinical research from a one-size-fits-all to a risk-based approach. TransCelerate framework focuses on elements identified as essential for successful implementation of ICH E8 as the foundation for the revisions to E6. This session will demonstrate the change of perspective and ways of implementing the GCP renovation, focusing on Designing Quality into Clinical Studies, Culture, and Engagement.

We tend to separate the worlds of issues and risk with different tools for each area. But they are closely related - after all a risk is a potential issue. Learn how you can use skills in root cause analysis to improve the quality of your risk controls in RBQM, how to tackle the challenge of not knowing the root causes of risk events, and discover why some RCA approaches are better than others.

This presentation will explore how advanced technology solutions and AI/ML are being leveraged to manage and monitor the ever-expanding volume and complexity of data being captured.

A centralized data review team ensures standardized, systematic medical data review focused on critical data and complex checks, complementing centralized monitoring signal detection. This model shifts clinical data review, including about 50% of EDC modules, to a centralized function, enabling efficient data flow from the first subject to close-out. The cross-functional review framework and automation tools, including listings, dashboards, and patient profiles, improve quality and performance. This agile framework with medical oversight protects the safety of study participants and ensures scientific data value.

In this session, we will discuss scenarios about how to strengthen the clinical vendor oversight using Risk Management system(s) and tools at the stage of vendor selection, risk assessment, defining the tailored oversight model, and using the dashboards which can help monitor the performance of the vendors in clinical trial.

ePRO instruments are used to support labeling claims and measure long-term treatment benefits in clinical trials. Deterioration of patients ePRO compliance over time may impair the Sponsor’s ability to collect primary or key secondary endpoint data. Large amount of missing data may impact reliability and interpretability of the clinical trial results. Risk identification, real-time monitoring and early detection of potential systematic issues play a key role in delivery. Based on a case study, we discuss the advantages of Risk-based Quality Management methodology implementation and the role of centralized monitoring in proactive and effective control of defect rates in the clinical trial.

Managing clinical trials, of any size and complexity, requires strategic planning, negotiations of agreements/budgets to ensure adequate resource allocation, risk mitigation and cost efficient execution. In order to successfully deliver innovative therapies to patients with unmet medical needs the trial management regulatory guidelines need to be standardized further, and robust methods of evaluation of study protocol complexity developed in conjunction with risk management strategies, patients’ feedback, and adequate provisions for participating sites in clinical trials agreements with accurate budgeting are needed.