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

Austin Allan
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.
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Shaheen Limbada
Executive Vice President, Global Clinical Operations, Veristat LLC
Shaheen Limbada is the Executive Vice President of Global Clinical Operations at Veristat. In this role, Mr. Limbada oversees Global Clinical Operations including, clinical monitoring, project management, site management and medical affairs. Mr. Limbada graduated from the University of Toronto and quickly began his career in clinical trials with AstraZeneca Canada Inc. With over 20 years of experience running clinical trials in both the sponsor and CRO setting, including building and successfully selling his own CRO, he excels in the areas of risk management, project management, patient recruitment and clinical study conduct and governance. He joined Veristat through the recent acquisition of Topstone Research, a Canadian-based CRO that he co-founded and held the position of Managing Director. Prior to Topstone, he worked in clinical operations, project management and leadership roles at various clinical research organizations (CROs) and pharmaceutical firms.
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Chelsey Ryan
Senior Manager, Clinical Trial Management at PROMETRIKA, LLC
Ms. Chelsey Ryan, Senior Manager, Clinical Trials Management, has more than 10 years of diverse experience in clinical research operations management, project management and technical systems management experience.
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