Internet-Intellignt Clinical Data Management: Using The Internet For Clinical Data Capture
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0092-86 I5/200 1 Copyright 0 2001 Drug Information Association Inc.
INTERNET-INTELLIGENT CLINICAL DATA MANAGEMENT: USING THE INTERNET FOR CLINICAL DATA CAPTURE JIM SCIBETTA, MS Clinical Applications Manager, Procter & Gamble Pharmaceuticals, Cincinnati, Ohio
This paper discusses use of the Internet in clinical trial data capture and suggests a series of nine attributes that such a system should incorporate. It begins by detailing Internet use in various industries, then traces the history of computerization within Procter & Gamble, portrays the many potential benefits of Internet use in clinical data capture, and makes a case for pharmaceutical companies to move in this direction. The term “Internet-intelligent clinical data management” is coined to describe a new paradigm that promises streamlined communications with investigators, partners, and staff worldwide. Strategies for facilitating organizational change are also suggested. Finally, conclusions are drawn summarizing what is at stake. Key Words: Data management; Web data capture; Internet data capture; Clinical data capture
THE INTERNET TODAY, MOST LARGE pharmaceutical companies have accepted the fact that computer systems and electronic data capture strategies represent a significant and necessary improvement in clinical data management, general clinical business operations, and overall organizational efficiency. Numerous worldwide Drug Information Association presentations continually showcase the latest case studies and improving metrics from being “connected” in clinical trials. This now being widely accepted, companies want to maximize their technology investment by exacting as much benefit as possible from those systems by using them more and more to
Reprint address: Jim Scibetta, MS, Clinical Applications Manager, Procter & Gamble Pharmaceuticals, Cincinnati, OH. E-mail: [email protected].
capture and manage clinical data as quickly as possible. The purpose is not only a cost-containment exercise in increasing efficiency in the organization in general and clinical data management in particular; It is also a vehicle for exploiting new drug development opportunities by knowing sooner whether to move forward or quit the drug program. Millions of dollars are at stake with these decisions. The ubiquitous public network known as the Internet lets companies better communicate with customers, partners, and employees and has enabled corporations to profoundly transform the way they conduct business. It has now been clear for some time that corporations that use the Internet for communications experience lower business costs and forge closer relationships with partners and customers. In an era of heightened competition, those companies with the best partner
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communications have been seen to win in the marketplace. The philosophy behind the Internet is to share centrally-stored information and provide universal access using only a Web browser. The Internet computing model distributes information easily to any user without the compl
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