The E6(R3) guidance marks a pivotal shift in the conduct of clinical research from a one-size-fits-all to a risk-based approach by emphasizing QbD, RBQM and CTQ factors. This session highlights the changes in the recently revised ICH guidelines and how biopharma companies can implement them.
- Discuss key highlights of the E6 (R3) guidelines
- Identify areas that may benefit from additional guidance
- Compare the E6(R3) to E6(R2) and E8(R1)
- Explore how sponsors and CROs are planning to adopt the new requirements
The FDA, in its most recent guidance, continues to encourage the use of RBQM throughout the entirety of the clinical trial cycle, starting with clinical trial planning and design. In 2022/2023 the Tufts Center for the Study of Drug Development conducted an extensive assessment on current levels of use of 32 distinct RBQM components, and gathered perspectives on challenges and opportunities associated with the implementation of RBQM in clinical research.
- Learn about a new comprehensive approach to assessing RBQM adoption
- See recent data on current levels of RBQM adoption among industry sponsors and CROs
- Analyze expected future levels of use of RBQM components
- Discuss perceived challenges associated with the implementation of RBQM components
- Review opportunities and benefits of RBQM implementation
- Grasp implications of these findings for the future of RBQM
This session will discuss a live use case on an active study to highlight:
- How analysis was selected
- What goes into setting it up
- Generic learnings from the study teams and auditing groups
RBQM practices are being increasingly adopted by industries globally due to their ability to enhance quality and improve efficiency. However, smaller and growing organizations may need help with implementing and executing them.
- Overcome implementation barriers
- Properly develop SOPs
- Plan for technology vendor outsourcing and engagement
It is imperative that clinical teams are constantly prepared for an inspection by the FDA or other regulatory bodies. Observations made by a health authority may affect a clinical experiment at any time, regardless of where they occur or who is responsible for the site.
- Learn how to prepare clinical teams for a clinical quality inspection
- Review key learnings from recent inspections to improve your inspection readiness plan
- Outline best practices for managing expectations and preparation strategies
- Explore clinical trial technologies and how they can impact inspection readiness
- Learn about different oversight strategies from experts in clinical operations, clinical outsourcing, and vendor management
- Discuss the various factors that influence decision-making when choosing where to invest in governance and relationship management
- Examine standardized way of benchmarking CRO and vendor performance
Increasingly, a clinical trial that lacks diversity will also lack credibility. It is crucial to invest the time and resources necessary to truly understand clinical trial diversity and to cultivate the new strategies and networks necessary for improving it.
- Examine clinical trial diversity as it relates to risk and quality management
- Understand the impact of clinical trial diversity
- Explore whether RBQM can be leveraged in addressing the lack of clinical trial diversity
Adopting RBQM is about more than just introducing new technologies or digital tools. It requires rethinking old habits and updating your team’s behavior.
- Hear from people who have successfully integrated RBQM and what their triggers were
- Discuss common challenges encountered when integrating a RBQM system
- Share lessons learned and recommendations provided on how to drive RBQM adoption
Many organizations struggle to identify, attract, and maintain the leadership they need. There are many moving parts to implementing a strong RBQM strategy, but at the heart of it is your team. Learn how to build an exceptional RBQM team.
- Discover what to look for, questions to ask, and how to interview
- Find talent that has the skillsets and vision to drive RBQM
Build a business case to demonstrate the value of the initiative and how it can positively impact trial quality, patient safety, and study efficiency
- Promote the appropriate processes and technology in your organization by identifying optimization areas to ensure technology isn’t supporting a broken process
- Gain cross-functional buy-in and educate stakeholders on roles and responsibilities
- Establish baseline metrics to measure program progress and success such as data quality and efficiency
The biggest obstacle to effective RBQM and the adoption of risk-based strategies is change management. Several factors contribute to this including organizational and human resistance to change, poor training and communication, and the lack of senior management support. Learn what your company needs to do to successfully implement RBQM in your organization.
- Recognize the value of creating a standardized change management and adoption process
- Establish guidelines for engaging stakeholders and change support expertise
- Identify, curate, and utilize common tools and practices for stronger change initiatives
Leveraging AI and ML in clinical trials is becoming increasingly popular. It can save time, improve accuracy, and reduce risks. Learn how to properly implement these tools in your organization to experience fewer errors and delays, improve data accuracy and consistency, streamline workflows, and optimize resource allocation.
- Separate fact from hype on AI and ML
- Implement the proper tools to leverage reliable and comprehensive data
- Identify challenges in implementing these tools and how other companies are utilizing them
With limited contingency resources, comprehensive risk planning is essential for efficient drug R&D. Current risk planning techniques face limits in the complexity of the clinical trial risk mitigation problem (e.g. multiple risks, multiple mitigation options per risk, mitigation impact uncertainty). Deriving an effective clinical trial risk mitigation strategy can be time-consuming without proper modeling methodology. For efficient risk mitigation plan execution, QTLs and Key Risk Indicators (KRI) should be optimally positioned and aligned with risk assessment, contingency resources, and risk monitoring strategy.
- Align clinical trial risks and contingency budget
- Optimally derive a clinical trial contingency budget aligned with risk tolerance and allocate the budget across risks and business groups responsible for risk mitigation
- Efficiently position QTLs and KRIs
- Define the most efficient starting point for risk mitigation
