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Program Code:
409
Date:
Thursday, June 27, 2013
Time:
9:00 AM to 10:30 AM
EST
CHAIR
:
H. Chris Ramm, (SCHNON), Global Director, Sales and Marketing, Clinical Ink, United States
SPEAKER
(S):
Catherine Celingant,
MA (SPKNON), Senior Director, Medical Business Operations, Medical Strategy and Operations,
Millennium: The Takeda Oncology Company, United States
Catherine Célingant has over 20 years of experience in Clinical Systems implementation and Medical Operations. Since 2003, Catherine has been involved in several PhRMA and eClinical Forum-sponsored groups working with regulators and other stakeholders to facilitate the adoption of EDC and eSource.
|
Jules Mitchel,
PhD,MBA (SPKNON), President,
Target Health Inc., United States
Dr. Jules T. Mitchel is President of Target Health Inc., a privately held New York City based full service e*CRO. Dr. Mitchel leads the team at Target Health to develop software tools to enable the "Paperless Clinical Trial, including eSource." Dr. Mitchel has held positions at Wyeth and Pfizer.
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Description
The collection and use of eSource clinical data is rapidly becoming the standard medium for clinical research. Regulatory authorities have been increasingly more vocal of their support for the use of eSource clinical data, a fact that may be helping in the continued adoption of eSource and electronic data capture in general during the conduct and assessment of clinical research.
This symposium will introduce risk-based approaches when electronic data are intended to serve as the source of clinical data. Additionally, we will discuss how monitors and data managers can work together when developing and implementing a risk-based monitoring program. A final topic is the assessment of electronic health record systems that will be the repository of eSource data.