Webinar: Best Practices for CRO Oversight
How an Oversight Capability Maturity Model and Automation Drive Speed and Quality of Clinical Trials
Please join Avoca and Comprehend for or an in-depth look at challenges and opportunities sponsors face in providing effective oversight and where/how they can progress their organizational and technical capabilities for oversight in order to optimize trial performance.
Interim findings from the 2017 Avoca Industry Research on Risk in Clinical Trials indicate that only 33% of Sponsors are satisfied with their Providers’ (CROs/FSPs) level of expertise and experience in applying risk-based approaches to quality management overall.
With impending changes necessary to address ICH E6 (R2), oversight is top of mind and requires sponsors to proactively answer questions such as:
- “Is my vendor doing what I hired them to do?”
- “Is the CRO adhering to my quality plan?”
- “Is the CRO’s performance meeting our expectations?”
- “What issues should we be escalating?”
Featured Speakers:
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Janis Hall, Senior Consultant, The Avoca Group
Janis Hall has over 25 years of experience in the healthcare industry with leadership roles in pharmaceutical, biotechnology, CRO and medical diagnostic companies. While at Johnson & Johnson Pharmaceutical Research & Development (J&JPRD) she was responsible for R&D sourcing, contracting and supplier alliance management. As the primary point of contact to health authorities for inspection readiness for strategic sourcing, she developed and successfully implemented an end-to-end process for inspection readiness of the sourcing organization. She holds a MBA from the University of Delaware and a BS in Chemistry from Towson University.
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Julie Peacock, Clinical Intelligence Expert, Comprehend
Closely aligned with customers and the sales organization, Julie focuses on enabling prospects and customers on Comprehend’s Clinical Intelligence solutions. She manages go to market strategy, sales enablement, and product marketing. Prior to Comprehend, Julie spent 18 years at Oracle Corporation in the enterprise application space where she managed strategy, field enablement and launch activities for a series of BtoB solutions. Julie holds a bachelor’s degree in Marketing from Auburn University. |