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Quality Digest

FDA Compliance

Clinical Trial Data Collection Conference Announced

Published: Tuesday, September 27, 2005 - 22:00

The Optimize Clinical Trial Data Collection and Exchange conference will be held Oct. 24–25 at the Sheraton National Hotel in Arlington, Virginia. Kelly Vaillant, Amgen Corp. global head of clinical data management, will serve as the conference chairman. Valliant and Tim Dietlin, Campbell Alliance senior practice executive, clinical development practice; will present a session titled “Leverage Electronic Data Capture Technologies to Build a World-Class Data Management Function” during the conference.

The conference will also feature informative sessions from more than 15 pharmaceutical and biotech executives who will discuss redesigning internal processes for the implementation of technology solutions, establishing clinical timelines and metrics, integrating clinical trial data with standardized case report forms, evaluating new clinical trial data management systems, and developing approaches to 21 CFR Part 11 and Sarbanes-Oxley compliance.

“The increased interest surrounding transparency in clinical trials is leading many in clinical development to reconsider the role technology should play in their organizations,” says Dietlin. “There has never been a greater need to automate the flow of clinical trial information, improve return on investment, lower drug-development costs, and understand an ever-changing regulatory environment.”

Speakers from AstraZeneca, Merck & Co., Pfizer Inc., TAP Pharmaceuticals Inc. and Wyeth Pharmaceuticals will also speak at the conference.

The event is sponsored by the Center for Business Intelligence, which is dedicated to developing market-driven conferences in pharmaceuticals\biotech, medical devices, risk and insurance and managed care markets. For more information, visit www.cbinet.com.

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For 40 years Quality Digest has been the go-to source for all things quality. Our newsletter, Quality Digest, shares expert commentary and relevant industry resources to assist our readers in their quest for continuous improvement. Our website includes every column and article from the newsletter since May 2009 as well as back issues of Quality Digest magazine to August 1995. We are committed to promoting a view wherein quality is not a niche, but an integral part of every phase of manufacturing and services.