What will ICH E6 R3 and ICH E8 R1 bring as benefits to sponsors and bring as changes in working practices. This presentation takes a holistic view of the changes as well as the benefits that everyone involved with pharmaceutical development (sponsors and CROs) will receive.

Is your organization prepared to meet the new ICH E8(R1) regulation for a culture of quality? Is your organization clear on what is meant by critical thinking and open dialog? Join industry expert Michael Torok, who will provide a foundational summary of a culture of quality and discuss how the critical thinking and open dialog strategic enablers can be improved to create a high performing culture of quality.

The shift to decentralized research can present new challenges in ensuring patient safety and data quality.  

By leveraging RBQM and central statistical monitoring tools, it enables pharma companies and CROs to evaluate new dimensions of risk and sources of variability in decentralized trial designs, maintain effective oversight of key risks, and ensure quality for patient-generated digital data.

In today’s world, amid the disruptions of a pandemic, adopting innovations to ensure clinical trial continuity has heightened the importance of robust risk-based quality management. The question then becomes, how do you conduct risk-based quality management without knowing where some of these risks are? In this session, we will share some of the most unique findings identified through our collaborative discussions, and highlight leading practices your organization can adopt. 

In this session, David Burrow will discuss the CDER Bioresearch Monitoring (BIMO) perspective on the beneficial use of risk based quality management systems (RBQMS) in clinical research. Dr. Burrow serves as the Director of the Office of Scientific Investigations within FDA’s CDER, Office of Compliance. He will be sharing his observations on adoption of RBQMS, including some potential opportunities for further evolution in the future. 

Risk-based quality management (RBQM) can contain numerous steps for study teams. How can study teams be certain they’ve completed the required steps? And, how can clinical operations executives easily know that their study teams are compliant or know if certain steps are problematic? This presentation shares how a web-based workflow can be developed and implemented successfully to promote the consistent application of RBQM methodology.

Sponsors and CROs need more than change management to operationalize decentralized trials. In this session, Kyle Hogan will outline the approaches sponsors and CROs can take to build value in the decentralized trial participant journey, from pre-implementation to study launch and monitoring. 

Delays in clinical trial patient enrollment are significant challenges for sponsors, especially for biomarker-targeted investigational therapies associated with rare genomic variants. Join us and discover the solutions offered by SOPHiA GENETICS, leveraging insights from multimodal datasets - including 770’000 genomic profiles - curated across 780+ healthcare institutions. We can better enable biomarker-driven clinical trials in oncology and inherited rare disorders to meet recruitment goals by identifying potential sites worldwide.

Discover the key recommendations of a multi-stakeholder team of industry experts–sponsors, CROs, vendors– who discussed lessons learned in implementing Quality Tolerance Limits (QTLs) and developed an approach to pragmatic implementation. The session will explore the use of leading KRIs as companion metrics to QTLs in order to obtain early signals. Earlier detection improves the chance of reducing impact on human subject protection and/or the reliability of trial results.

Since the introduction of Quality Tolerance Limits in ICH-E6 R2 five years ago, sponsors should apply QTLs as one of the risk controls in Clinical Trials. There has been a lot of work done to understand QTLs in the context of managing quality in pharmaceutical industry. However, doubts around QTLs values determination are still there. This presentation will focus on sources of information that can be used to properly set QTLs, with emphasis on historical information.

As risked based approaches become the norm, quality compliance will increasingly be managed through Advanced Analytics & AI/ML Capabilities. Well defined processes and technologies are a must and will pave the way for predictive and proactive signal detection. Through case studies covering ML integration in monitoring learn how trends in advanced analytics and AI/ML are driving post pandemic remote focus.

Expected to land soon, the public draft of ICH E6(R3) brings renewed focus to Risk Based Monitoring in clinical trials. Dario Lirio, Senior Product Director, LifeSphere Clinical at ArisGlobal provides perspective on how technology can enable operations professionals to prepare for the new guidance. Will the new ICH E6(R3) draft guidance bring more clarity or add new implementation challenges to adopting risk-based practices?

Digital capabilities including remote monitoring, electronic patient-reported outcomes, and wearable sensors, are enabling clinical trial decentralization at scale. Robust DCT execution requires proactive, scalable central monitoring strategies to interrogate data at point of capture, minimize study risk, and provide continuous oversight of data integration, flow, and quality. This session explores how DCTs have evolved and elevated RBQM strategies towards the new normal for clinical operations.