June 3, 2021
9:15 – 10:00 AM
Reach For World Class Enterprise Risk Evaluation and Adaptive Integrated Monitoring
You may need to completely disrupt your operating model, process, people and technology in order to arrive at world class risk management. Embrace a strategy that builds and strengthens core competencies to achieve next level performance.
- Be willing to allocate resources to highest risk areas
- Standardize and industrialize to build a platform for innovation.
- Determine core competencies and why that’s relevant for your journey
- Key takeaways from regulatory inspections and future planning steps
- Develop the right tools and retain employees to reinvent monitoring for the future
The key factor for successful RBQM implementation and ongoing management hinge upon setting up for success at the onset. In order to maximize the value of your RBQM plan you must be intentional with how the components fit together. Quality will suffer if a strategic, end-to-end approach is overlooked.
- Ensure you have the right components and understand their interdependencies
- Sharpen skills for risk identification, mitigation and response
- Ensure that risk assessments feed into monitoring programs
The COVID 19 pandemic has forced industry to “walk the walk” when it comes to quality risk management. As we begin to move out of COVID, there is an opportunity to apply the lessons learned to maintain a level of risk tolerance and to be more agile in clinical trial oversight.
- Discuss whether regulators will continue to accept remote monitoring and digital technologies and engage authorities around other areas that may benefit from shifts away from current models
- Plan for and initiate a culture of quality to continue to shift toward proactive risk management
- How do we ensure better trial oversight through remote activity?
- Examine whether implementing quality by design for protocol development will enable parallel focus on innovative science and molecule development
Dr. Joseph M. Juran developed the concept of quality by design (QBD) and many industries have embraced it. What does it mean for the biopharmaceutical and device industries? How far we have come and where we will be in the near future?
- Understand the baseline for using QBD by linking ICH6
- Determine the approach for identifying critical quality factors and methods for ideal metrics management
- Focus on what regulators expect in QBD
June 3, 2021
1:00 – 1:45 PM
Focus on aSystematic Approach to Risk Management Including Process Controls
There is a tremendous opportunity to leverage the relationship between clinical and manufacturing functions to advance quality and risk management systematically. Biopharma manufacturing has leveraged process controls to ensure continuous quality improvement and quality by design over the last number of years.
- Discuss the realities of applying Six Sigma to clinical research
- Get closer to the issues that matter – what do you measure and when it goes out of control how do you address this? Do you apply root cause analysis?
- Determine what data is trending and how to best utilize this
- Examine adaptive design
There is a strong correlation between placing reasonable thresholds and setting effective key risk indicators. Consider whether it’s practical and timely to move away from attempting perfection to a space where you define quality and have acceptable errors inside.
- Set yourself up for success with QTLs and avoid unreasonable thresholds
- Evaluate what happens when thresholds are exceeded and whether subsequent data are still valid
- Consider why QTLs and KRIs must line up and how QTL management can be more robust
Building or buying new technology tools is not the most difficult aspect of implementing a successful RBQM system. Scalability of the usage of the tool is the hardest piece and it is critical to lay the foundation correctly to ensure success of the system.
- Identify the essentials for ongoing management of the tool
- Build in data standards and strive for standardization as you refine protocols
- Realize that standard protocols lead to standard data collection and leverage as much as possible from standardization to avoid excessive customization
Sponsors had been somewhat slow to adapt to technology-based approaches to monitoring trial data. In the wake of COVID, the absence of on-site monitoring has led to an acceleration in the adoption of these technologies.
- Clarify expansion of monitoring to include remote data monitoring, site, and central monitoring
- Assess methods to remotely review data
- Discuss how COVID-19 changed attitudes
- Consider new tools for remote data surveillance
- Support study teams in performing data-related risk assessments
June 4, 2021
10:00 – 10:45AM
Reduce Source Data Verification and Appraise the Site Monitoring Role in Risk Based Monitoring
Closing the loop on risk based monitoring and ensuring that we evolve the site monitor’s role to tie together the risk assessment and the central monitoring findings is a critical component to a successful RBQM program.
- Articulate the CRA’s responsibility in the site monitoring role
- Discuss change management and where industry is in the curve
- Track the evolution of the role of the site monitor
- Reshape how your study gets audited
June 4, 2021
Analyze Expedited Development and Use of a New Data Visualization Dashboard to Address the Impact of Covid-19 on our Clinical Trials
With the Covid-19 pandemic upon us, we had to create a quick and easy way to review data trends at multiple levels for our clinical trials.
- Understand why it was developed, focusing on central monitoring
- Hear about what was developed to support our trial teams
Gain insight into how it is being applied to Deviation and Adverse Event Trending and other data reviews
Discover more about the management of RBQM in vaccine trials and key takeaways.
Examine frequency analysis
- Consider adaptive approach to risk
- Analyze QTL & KRI interaction
- Review the complete cycle for signal management to site follow up and back
Learning from examples of 483 warning letters is a good way to know what to look out for and stay “inspection ready”. Establish and maintain a single source of truth for study and site quality management, to ensure inspection readiness.
- Address risk-based approach and tools (RACT) used to optimize inspection readiness
- Delve into deviation management
- Hear about the most common FDA findings in inspections
- Consider what types of corrective actions could be necessary and why timeliness is important regarding the 483 response
- Implement end to end mock inspections and tactics for demonstrating audit trails
Vendor oversight is a critical piece of the risk based quality management plan (RBQM). The sponsor is responsible for the quality performance of CROs, vendors and subcontractors.
- Develop a vendor oversight SOP
- Create documents for oversight and quality management of CROs, vendors and subcontractors
- Identify a vendor risk management plan