august, 2014

07aug8:00 am10:00 amUnderstanding Risk-Based Monitoring – Pros, Cons & the Bottom Line


Event Details

Location: MassBio, 300 Technology Square, 8th Floor, Cambridge, MA

The FDA has joined the growing consensus in the pharmaceutical industry that risk-based approaches to monitoring will help ensure subject protection and overall study quality.

How well do you understand risk-based monitoring?

In a recently issued Guidance, FDA now encourages sponsors to consider a change in approach to monitoring to risk-based approaches.

Please join us to explore the implications and future of Risk Based Monitoring to your clinical programs. We will address such issues as:

  • What are the different approaches?
  • What departments within your company will need to be involved in development?
  • What are the regulatory implications?
  • Is this approach appropriate for all phases and all indications?
  • Is your company interested in taking this on and but you need to know how to get started?

These questions and more will be answered by our panel of experts who have already faced these hurdles. Listen to a case study of how the approach was successfully implemented and what challenges were faced.  Bring your own questions and join us on August 7th to learn more.


  • Marc Buyse, Founder, CluePoints Inc.
  • Becky Carpenter, Vice President, Operations, ResearchPoint
  • Ken Light, EVP, Transformational and Professional Services, OmniComm


  • Kelly Blackburn, VP, Clinical Affairs at aTyr Pharma

This Forum is presented by the Biostatistics/Data Management/Clinical Trials Forum Working Group.


(Thursday) 8:00 am - 10:00 am