Refocusing on Risk Mitigation in Starting Clinical Trials

While risk management efforts in drug development have focused mostly on post-marketing drug safety, the clinical trials process has its own mix of potential risks waiting to derail a company’s multimillion dollar development programs. Risk-based challenges are escalating as clinical trials become more global and complex, and as market pressures keep rising for new therapies at an ever-increasing pace. The webinar will focus on study startup and discuss best practices for the identification and mitigation of potential risks before they occur.

In this webinar we will explore:

• Considerations for assessing the best fit between sites and Sponsors/CROs (i.e., intelligent site profiling)
• The importance of automating document workflows (i.e., alerts, ensuring regulatory/SOP compliance, role based assignments)
• The need for standards and cycle-time metrics for benchmarking (i.e., performance monitoring)
• The identification of red flags and the importance of real-time metrics to drive timely interventions
• Project reporting with milestone tracking and re-projection
• Improving collaboration with transparent communications

Speakers

Rob Wynden, VP Technology and Engineering, goBalto

Rob has been a computer scientist and programmer for over 30 years in the scientific programming, e-commerce, biotech, and health care industries. He implemented study startup and CTMS functionality at 9 bay are biotech companies, and invented a method that allows medical and biotech organizations to use cloud-based analytics to monitor patient data. He holds a BS in Computer Engineering from Sacramento State University and a PhD in Biological and Biomedical Clinical Informatics from UCSF.

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Linda Sullivan, Co-Founder and President, Metrics Champion Consortium

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.

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Andrea Sim, VP Product, goBalto

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.

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