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.
For study startup, a problematic area of clinical trials, these risks include site selection and patient enrollment issues, budget and contracting delays, logistical problems with timely drug shipments, and regulatory hurdles. 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 webcast will focus on why risk management and assessment are most effective when integrated into clinical trials from the beginning – the study startup phase – rather than as an afterthought.
Please join us for this webcast:
Live: Tuesday, May 28, 2019
1pm EDT | 12pm CDT | 10am PDT
On Demand: available after airing until May 28, 2020
This webcast will explore:
This webcast is applicable to:
BARRY MILTON, Head of Business Operations, Novartis Institutes for BioMedical Research
Barry is a clinical trial and operations management expert. His experiences as an oncology nurse and a clinical trial coordinator, as well as his senior management roles at Novartis, Roche, Merck, and AstraZeneca provide him with a well-rounded set of skills and experiences in the clinical trial space. His passion is transforming study management and trial execution processes through the creation of optimized business processes. These processes are supported by facilitating systems, which allow sponsor and investigator teams to meet their patient and clinical program goals faster and more efficiently.
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.
ELVIN THALUND, Director, Industry Strategy, Oracle Health Sciences
Elvin is a recognized industry expert in clinical trials, having over 20 years of experience working as a Clinical Business Analyst Consultant at major pharmaceutical companies including, Hoffmann-La Roche and Johnson & Johnson. He works as a product strategist and system architect in goBalto's effort to optimize study startup. Elvin is the co-chair on the TMF Reference Model Exchange Mechanism and holds a Master of Science in Industrial Engineering from Aalborg Universitet.