Active oncology R&D compounds have quadrupled since 1996 and doubled since 2008. With accelerated approvals and breakthrough designations, where speed is of essence, fierce competition has become inevitable. But speed doesn’t necessarily mean faster approvals because oncology clinical trials are also becoming increasingly complex. Fortunately, revised ICH E6 guidance on risk-based monitoring (RBM) can fundamentally transform these approaches to help keep up with fast-paced oncology trials, contrary to popular belief that RBM can slow you down.

How is ICH GCP E6 R2 making it easier for patients to receive the right treatment at the right time? What can you do to stay ahead of the competition?

Join thought leaders from EMD Serono, Accenture and Medidata to learn about:

  • Essential elements of RBM, straight from the drawing board of ICH E6 R2 working group
  • The unspoken patient impact of RBM
  • RBM’s role in addressing complexities in oncology clinical trials with a roadmap to get ahead

Featured Speakers

David Nickerson

Head, Clinical Quality Management
EMD Serono

David has a global responsibility for the strategy, implementation and oversight of a risk-based approach to quality planning, control, and improvement for the clinical development portfolio and associated business processes. David was a member of the Expert Working Group responsible for the development of ICH E6 R2.

Colin B. Aherne

Senior Manager
Accenture - Global Life Sciences R&D

Colin is a Senior Manager within Accenture’s Global Life Sciences ARDS Practice with over 20 years of technology and business consulting experience. He has deep expertise in IT strategy, large program delivery and post-merger integration with a focus on Clinical Development / Operations systems and processes.

Stacey Yount

Vice President, Product - Strategic Monitoring
Medidata Solutions

Stacey currently leads product development, commercialization and services for CTMS and Strategic Monitoring platforms. She previously led Medidata’s Data and Analytics Consulting Practices where she transformed operational organizations through data assets and innovation including machine learning. 

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