Uncovering Trial Bottlenecks with Performance vs. Regulatory Metrics

Building Quality into Study Startup

The sharpening focus on quality management is fueling greater use of standardized metrics to optimize clinical trial performance. But just because data from disparate sources can now be aggregated does not necessarily mean that this information or the resulting metrics are actionable, or can identify risk proactively. That's why targeted performance metrics that measure the many details of clinical trial operations are essential. And for study startup (SSU), performance metrics are critical for meeting site activation timelines and study completion milestones.

Each SSU task is composed of multiple steps, and performance metrics are needed to evaluate them at a granular level, to spot bottlenecks and identify processes ripe for optimization.

The information revealed by tracking all the sub-steps in near real-time fashion is in stark contrast to what is provided by so-called regulatory metrics, which are generated from data entered into the TMF, and are auditable. There is a lack of business intelligence with this approach, forcing stakeholders into reactive mode, since the information does not pinpoint which sub-steps are problematic and only becomes available after milestones are achieved.

In this webinar we will explore:

  • How upfront planning, monitoring, and intervention drives process improvements that boost quality of the eTMF and the study overall
  • How standardized performance metrics can help to optimize the SSU process by providing transparency
  • How a pro-active stance towards performance metrics opens the door for benchmarking, efficient resource allocation, and forecasting or predictive analytics

This webinar is applicable to:

  • Sponsor and CRO roles responsible for site selection and activation
  • Sponsor and CRO roles responsible for collecting and evaluating trial metrics
  • Sponsor and CRO roles responsible for regulatory trial management


Ivan Walrath
Ivan Walrath is the Head of Audit and Inspection Quality at Pfizer, which includes responsibility for the Trial Master File, Corporate Registry, Audit CAPA Management and Inspection Readiness.

Ivan has been at Pfizer for more than 22 years in the clinical trial arena, including monitoring, study management, clinical project management and records management, where he worked on the development and implementation of Pfizer's first electronic Trial Master File in 2000 as well as the more recent implementation of Pfizer's current TMF process and eTMF system. With his extensive knowledge of clinical trial execution, TMF processes and eTMF systems, Ivan is looked on as an industry leader in this field.

Before joining Pfizer in 1995, he coordinated clinical trials in Philadelphia, where he managed trials conducted in depression, anxiety and schizophrenia. He holds a Master of Science degree in Organizational Management from Eastern Connecticut State University and a Bachelor of Arts degree in Psychology from the University of Pennsylvania.
Head of Audit and Inspection Quality
Ms. Sullivan is Co-Founder and President of the Metrics Champion Consortium (MCC), an industry association dedicated to leading the drug-development enterprise in the adoption and utilization of standardized metrics and benchmarks to drive performance improvement. She has been a featured speaker at Performance Metrics, Risk-Based Monitoring, Quality Management and Clinical Trial Oversight industry meetings.

Ms. Sullivan received a B.S. in biology from Trinity College and a M.B.A. from Dartmouth College, where she was named a Tuck Scholar.
Co-Founder and President
Metrics Champion Consortium
Linda Sullivan
Andrea Sim
Andrea has over 20 years of product management experience, most recently serving as VP of Product Management for RelayHealth where she was responsible for product strategy, research, and strategic initiatives around Health Information Exchange and Clinical Integration. Her career has also included product management roles at Healtheon/WebMD, Quovadx, and Oracle Corporation. Andrea holds a Bachelor of Arts degree in Molecular Cell Biology from UC Berkeley.
VP Product

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