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R&D Directions’ Data Management For Clinical Trials Webinar Details Data Capture And Management Strategies

NEWTOWN, Pa., April 1, 2009 –– R&D Directions announces the availability of the magazine’s first-ever interactive Webinar. Focusing on data management for clinical trials, the free Webinar features insight from industry experts Nick Lucas, Ph.D., VP, global data management, INC Research, and Steven P. Marra, Ph.D., senior research and design engineer, M2S Inc.


In the Webinar, Dr. Lucas discusses the strategies and challenges of managing the knowledge transfer process for electronic data capture (EDC) products. He emphasizes that implementation of EDC technology within an organization requires significant investment in scope and training and that hand-over responsibilities from the service provider to the client should be goal driven, not time driven.

“The biggest challenge for these products is the pressure to get them online to meet the timelines needed by the projects to go live,” Dr. Lucas says.

According to Dr. Lucas, in an average month, contract research organization INC Research juggles 170 studies, 40% of which involve EDC. He says it is important to distinguish EDC from the broader term e-Clinical. “e-Clinical is a much more comprehensive offering. It is the integration of other operational systems. The move toward e-clinical is [still] someways away. There are other systems that we need to bring into the EDC mode.”

In addition, Dr. Marra shares insight on the growing role of imaging in helping sponsors conduct more efficient and cost-effective clinical trials. He outlines several advantages electronic image management offers compared with traditional “hard media” methods, including faster data transfer to the core lab, immediate quality control, and accelerated query resolution.

“With imaging files, you are dealing with enormous amount of data,” Dr. Marra says. “There are several steps involved in transferring imaging data. With hard media, the average time for a study to come off hold after query is five days. With electronic distribution, it’s two days. That’s a significant savings in time.”

R&D Directions next Webinar, “Investigator Site Solutions for Clinical Trials,” is scheduled for September 2009.

About R&D Directions
Published 10 times per year, R&D Directions provides insight into pharmaceutical research and development, from discovery through clinical trials and submission. R&D Directions is written in a non-clinical, non-technical style and focuses on pharmaceutical companies’ R&D business strategies and decisions. Editorial content covers drugs, therapeutic categories, and industry segments, and imparts extensive intelligence on products in the pipeline.

Posted: April 2009

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