- Map out where companies fall in the maturity model and what components they are using for each stage of RBQM implementation
- Explore whether this model is a good representation of your company
- Guide sponsors throughout their process
As leaders in research compliance, we work with researchers but all too often fail to recognize a basic principle of research: data matters. A high functioning office not only maintains it operations with integrity and efficiency, but also undergoes continuous and evidence-based quality improvement.
- Discuss how to develop and implement data-driven programs of QI within research compliance offices
- Outline methods for collecting, assessing and using data for: selection of QI areas on which to focus
- Implement QI activities and assess programmatic outcomes of QI efforts
The global AI in clinical trials market size is expected to have a compound annual growth rate of 16% during the forecast period of 2023-2035. Machine learning has been used to help improve the efficiency and quality of certain procedures. How can AI and machine learning be used to assess and monitor risk in a trial?
- Review how AI and machine learning are used in RBQM
- Address intellectual property risk when using AI
- Compare how large and small pharma companies are implementing technology in their RBQM process
The largest obstacle in adoption of RBQM is change management. There is a lack of communication, training, and translation of concepts between teams when working to implement company-wide changes. What strategies must your team implement – and what will slow you down?
- Clarify why companies struggle so much with change management
- Consider different approaches to change management from the sponsor, site, and CRO perspective
- Create awareness and understanding on the best strategies for implementing RBQM into your company
One of the most used centralized monitoring tools are key risk indicators (KRIs). Looking into leading and lagging indicators can help you with clinical risk detection. Is your team detecting KRIs early enough in your study?
- Illustrate the difference between leading and lagging indicators and how each pertains to clinical risk detection
- Unveil the importance of KRIs in your clinical trial
Overall, 57% of sponsors and CROs have adopted RBQM in 2024. What is risk-based quality management? What does it include? Once you understand what is included in the full scope of RBQM, your team can start learning how to successfully integrate it into your company.
- Investigate case studies of successful implementation of RBQM adoption
- Clarify what is included and what new skills and resources you need
- Talk through common pitfalls when implementation pitfalls
RBQM practitioners proposed several techniques for efficiently positioning the QTL and the Secondary Limit/Early Warning (SL) thresholds. The methods include historical trends analysis, Statistical Process Control, and mathematical modeling. Can your team discuss each technique's limitations, advantages, and disadvantages for small, medium, and large companies and different types of clinical trials?
- Discuss QTLs and their importance in RBQM
- Showcase different modeling techniques for QTL positioning
- Examine QTL and SL threshold positioning as a part of a clinical trial risk mitigation strategy
Large pharmaceutical companies are moving the needle aggressively when adopting RBQM tactics. However, smaller companies are finding it hard to implement RBQM into their trials based on the trials size. How can smaller companies remain competitive when dealing with larger pharmaceutical companies?
- Discuss implementation barriers in small pharmaceutical companies
- Explain the different ways large companies assess risk
- Assess ways that smaller pharmaceutical companies can stay competitive compared to larger pharma companies
Embracing the QbD approach will undoubtedly contribute to the continued improvement and advancement of the pharmaceutical industry which benefits patients and healthcare providers. This methodical framework enables proactive identification and mitigation of potential risks, ultimately leading to optimized processes and consistent, reliable outcomes.
- Understand the benefits of adopting a QbD approach and how it will require a quality culture change within internal and external organizations
- Case Studies: Identify the critical challenges to implementing the QbD methodology and how to overcome them
- Learn how to acquire the necessary resources and expertise within your organization to help drive QbD
Risk-based monitoring focuses on risk assessment and management, centralized monitoring, and targeted on-site monitoring. There is also a focus on patient safety and data quality. How can risk-based monitoring foster more efficient and reliable clinical trials?
- Lay out the process of RBM vs. RBQM
- Debate the importance of RBM in clinical trials
Your team must always be prepared for an inspection from the FDA. How have these inspections changed post-COVID with respect to remote and hybrid models? What are the best practices for managing preparation strategies?
- Scrutinize strategies for enhancing preparedness in inspections
- Navigate how vendors can support the sponsor
- Review the importance of technology and how it can impact inspection readiness
On June 26, 2024 the FDA released a draft guidance on “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies.” How can your team incorporate this into RBQM language during early trial stages?
- Explain the importance of the FDA’s Diversity Action Plan
- Deliberate the challenges of implementing the diversity plan so early on in a trial
- Brainstorm how to improve diversity in your clinical trials
Whether you are working at a sponsor, site, or CRO, chances are that you are working with a legal group that faces the challenges of protecting their organization while also striving towards realizing its most efficient process. What can you do to help legal find a faster turnaround time, for your projects?
- Properly explain to legal what you need (services and deliverables)
- Utilize standardized contracts, templates, and clauses
- Establish relevant and realistic fallback provisions
- Work with internal SMEs to get pre-approval for certain scenarios
A risk-based quality management framework can include risk-based monitoring and risk-based data management. Foundational components of risk-based monitoring may also set the framework for risk-based data management, creating stronger connections between central monitoring and data management.
- Assess the similarities between risk-based monitoring and risk-based data management
- Explore derisking protocols and the data collection process
- Discuss monitoring of critical data from different perspectives
