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Halloran Speaker Series | The Future of RBQM and Customized Key Risk Indicator Libraries: How Small Companies Can Take Big Steps to Reduce Risk and Trial Oversight
April 27, 2022 @ 2:00 pm - 3:00 pm
Identifying the key risks to be monitored in a clinical study is critical for a successful implementation of a Risk-Based Quality Management process (RBQM), and even more, to the overall success of the clinical trial. Identifying the right Key Risk Indicators (KRIs) is also of utmost importance because they are the risk indicators that enable clinical study teams to proactively make informed decisions along the way. To put it simply, a study team needs the right KRIs to actively monitor the trial’s risks.
We’ve witnessed many small biopharma companies wonder if there are different ways to identify and manage KRIs for their trial, particularly, because many face the challenge of not having enough data to inform KRI selections from the onset. Some companies just don’t have that data and insight, so they often rely on a KRI library from their vendors.
As we zoom out from those observations, we want to share our insights with you on the future of RBQM that will be helpful especially to smaller companies, particularly around the following questions:
If you don’t have enough data to inform decisions on KRIs, where do you start?
How do you implement a risk-based quality management process to inform KRIs?
Should companies have a library of KRIs to utilize from the onset?
What does it look like to overdo it vs. underdo it and why does this viewpoint matter?
How should companies partner with their vendors on KRIs?
How should you develop KRIs if you outsource your studies to CROs?
When should you start developing KRIs and your RBQM processes?
What does the future of customized risk management look like?
We invite you to this conversation on Thursday, April 27th from 2-3 pm ET on “The Future of RBQM and Customized Key Risk Indicator Libraries How Small Companies Can Take Big Steps to Reduce Risk and Provide Trial Oversight” led by Sheila Gwizdak, VP of Quality at Halloran Consulting Group, and members of the Organizational Quality Solutions and Clinical teams during our Halloran-hosted Speaker Series.
