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How to Stop EDC From Causing Sites Pain 

Recorded on May 25, 2011 | DVD or Electronic Version for Purchase: $295*

Sponsored by CMED  

Summary:

This Symposium’s speakers from the investigator, sponsor and eClinical technology areas will focus on the well-known topic of “electronic data capture causing sites pain.” eClinical platforms can provide a fast, reliable Google-like experience by using cloud computing and mobile technologies to overcome:
 

  • Slow EDC systems especially during key milestones like database lock, 
  • Being tethered to high-speed Internet connections and not having an offline capability and 
  • Not being able to access clean clinical data when needed. 

Speakers: 

  • Marina H. Nillni, PMP, Dana-Farber Cancer Institute (DFCI) Clinical Trials IS 
  • Jim Haughwout, Vice President for Commercialization and Operations, Cmed Technology 
  • Dr. Margot Johnson MBBS, MD, MRCOG, Director, Global Clinical Lead for Apixaban VTE Treatment, Pfizer 

About the Speakers:
Marina H. Nillni, PMP, Dana-Farber Cancer Institute (DFCI) Clinical Trials IS
Marina H. Nillni holds a Bachelor of Science degree in Mathematics and Statistics from the Hebrew University of Jerusalem, Israel. She is a Project Management Institute (PMI) certified Project Manager Professional (PMP) with more than 27 years of experience managing software/IT related projects. Marina led the Dana-Farber/Harvard Cancer Center in its search for an Electronic Data Capture (EDC) solution for their in-house clinical trials program in 2004 and she is currently overseeing the enterprise adoption of EDC at the Cancer Center. To date Dana-Farber has implemented over 176 EDC trials across more than 120 sites in the USA, Canada, Australia, New Zealand and Israel covering 18 different oncology specialties. Marina is a Corporate Team Leader II within the Partners Information Systems organization which supports the DF/HCC Information Systems needs.

Jim Haughwout, Vice President for Commercialization and Operations, Cmed TechnologyJim is responsible for commercial readiness, operation and support of Timaeus, Cmed’s on-demand eClinical platform that provides the freedom to manage any type of data, for any protocol, anywhere. His 18-year background combines experiences in the clinical, commercial software, and consulting arenas with a focus on combining process and technology for industry-leading performance and efficiency. He has helped accelerate the development process from protocol design through regulatory submission and safety monitoring for a wide range of clinical trials: from global biologic mega-trials to electronic vaccine trials in Africa.
 

Dr. Margot Johnson MBBS, MD, MRCOG, Director, Global Clinical Lead for Apixaban VTE Treatment, PfizerDr. Margot Johnson MBBS, MD, MRCOG gained her medical degree at University College London and  MD at St Mary’s in London. She then practiced as an obstetrician and gynecologist in England and Scotland for 18 years, lastly at the Glasgow Royal Infirmary. She relocated to the USA in 2002 and has worked for Pfizer running Phase 3 global studies over the last 5 years. She has been involved in the compilation and submission of NDAs to the FDA and presented at advisory committees and at EU regulatory meetings. Dr. Johnson is currently running  two global phase 3 studies enrolling 8,000 patients from 850 sites with data  being captured electronically. 


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