Lessons Learned From Implementing Risk Based Monitoring (RBM)

October 17, 2019 8:00 AM - 10:00 AM

MassBio, 300 Technology Square 8th Fl, Cambridge, MA 02139

Add to Calendar 10/17/2019 8:00:00 AM 10/17/2019 10:00:00 AM Lessons Learned From Implementing Risk Based Monitoring (RBM)

Risk based monitoring (RBM) offers many advantages over the traditional approach of 100% source document verification. Plenty of sponsors and CROs can attest to this with facts, figures, and case studies. Regulators even encourage sponsors to utilize this approach. So it’s a no brainer right? Well it depends on your organization and the kinds of studies you are running.

In this forum we will explore the many facets associated with RBM and answer questions such as:

  • What are the most significant pros and cons?
  • Are there types of studies that RBM is more or less optimal for?
  • How do I ensure I have selected the right CRO partner?
  • What is the impact on costs and timelines?
  • How do investigational sites feel about RBM?

Join the discussion with our experienced panel who will explore these and many other questions surrounding this approach to monitoring. The hope is that you will leave this discussion better prepared to determine the best path forward for your organization.

Sponsored by the Biostatistics, Data Management & Clinical Trials (BSDMCT) Forum Working Group.

 MassBio, 300 Technology Square 8th Fl, Cambridge, MA 02139
Head Research and Clinical Development Quality Operations, Alexion Pharmaceuticals
With 20 years’ experience in the pharmaceutical industry, including time in roles in Quality Assurance, Clinical Operations, process management, and information/records management, Austin brings a passion to driving for the absence of errors that matter and is committed to enhancing patient-centric work processes. He currently leads the Research and Clinical Development Quality Operations (Hematology/Nephrology) team at Alexion and is responsible for the implementation of Risk Based Quality Management across the Alexion portfolio.