(Tuesday, June 3 1:00-3:30 pm)
(SC2) Metrics & KRIs: Study Oversight in a Risk Management Environment – How to Make It Work!
Peter Schiemann, Ph.D., Managing Partner, Widler & Schiemann Ltd.
Ken Schiff, BA, MBA, Quality Risk Management Associates, LLC
Key to the success of QRM is the capacity to leverage existing information in such a way that stakeholders can easily assess whether the processes they are responsible for yield (or will yield) the intended results and quality. This approach helps organizations to proactively identify, manage, and mitigate risks before they manifest into real problems. A risk-based approach requires not only a strategy but tools to define leading and lagging indicators to measure specific risks. As referenced from the recent FDA and EMA guidances, Key Risk Indicators (KRIs) and Critical to Quality (CTQ) metrics should focus on “what really matters” with an emphasis on patient safety and data integrity, and be tied to particular processes within the clinical drug development spectrum. This interactive session is designed to provide its participants with a strong conceptual foundation for defining and developing meaningful Quality Risk Indicators and Critical to Quality metrics along with corresponding thresholds for acceptability of outcomes that can be used across clinical trial processes.
(Tuesday, June 3 6:00-8:30 pm)
(SC3) Managing the CRO Relationship: From Engagement through Delivery
Michael J. Harte, Founder & President, The Harte Group
In this workshop, we will explore effective and creative approaches to the Sponsor/CRO relationship, from engagement through delivery. Participants will learn to:
- Ensure the validity and accuracy of their program: Validate the protocol and assess patient availability and compliance
- Start with the end in mind: Regulatory expectations; data presentation; and study goals
- Consider key points in CRO engagement: CRO pricing; development activity and objectives; the use of electronic systems; vendor workflow and process; taking steps to engage QA support to maintain audit-readiness of your program; encourage input from CRO functional groups for better, creative, and more efficient ways to conduct the program
- Identify ways that the CRO can be held accountable for their deliverables: Deliverable-based vs. time-based contracts; if wrong selection of CRO made, never fear changing
- Ensure total transparency of all parties/functions: Better communication ensures that everyone aware of status and need for their services
*Separate Registration Required