Refocusing on Risk Mitigation in Starting Clinical Trials

Craig Morgan
Head of Marketing, Study Startup

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

Register here.

This webcast 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.

This webcast is applicable to:

  • Sponsor and CRO roles responsible for site identification, feasibility assessment, selection and activation.
  • Sponsor and CRO roles responsible for collecting trial documentation.
  • Sponsor and CRO roles responsible for project management of studies and operational excellence.


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.



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