Pushing past the paper


Copyright: This PDF purchase is for a Single user for review or filing purposes only. The PDF is watermarked. If you are interested in a PDF reprint to post on your website or distribute electronically, or hard-copy reprints, please contact Marah Walsh at

Product Description

While adoption of a paperless approach by pharmaceutical companies has been gradual, Forrester Research, based on a recent survey of 400 pharmaceutical professionals, is projecting that 24% of all new clinical trials will be Web-enabled by 2004.
Integrated electronic application, many say, is the next step in the evolutionary process. The effective and efficient use of integrated enabling technology solutions can impact every stage of drug development from discovery to preclinical, through clinical to post-marketing, and ultimately to commercialization, including direct-to-consumer promotion. Companies that continually strive to maximize successful product development are, albeit slowly, starting to develop EDC-based performance metrics, and deploy strategies for building clinical data warehousing and archiving, while meeting regulatory requirements.

A Brief on the Benefits

Experts on this topic
Paul Bleicher, M.D., Ph.D. Founder and ­Chairman, Phase Forward Inc., Waltham, Mass.; Phase Forward is a leading provider of clinical and safety data ­manage­ment solutions for drug ­develop­ment
Scott Burcham. Director, Centralized Spirometry, Biomedical Systems Inc., St. Louis; Biomedical Systems develops creative approaches to centralized diagnostic services and merges advanced technologies with established clinical
software to meet the needs of its clients
John Cline. President, etrials, Morrisville, N.C.; etrials offers efficient data ­management products and services for ­collecting, monitoring, and assessing ­quantitative and qualitative study data
James J. Conklin, M.D. President and CEO, Araccel Corp., Horsham, Pa.; Araccel is a global leader in providing validated, innovative, and proven e-clinical solutions that capture, maintain, analyze, distribute, manage, and report clinical-trial data
Chris Couch. VP and Chief Operating Officer, Perceptive Informatics Inc., Waltham, Mass.; Perceptive is the information technology subsidiary of Parexel Inc., which is an outsourcing organization, providing a range of knowledge-based contract research, ­medical marketing, and consulting services to the worldwide pharmaceutical, ­biotechnology, and medical-device ­industries
Edna Stoeher. Project ­Manager/National Registry of Myocardial Infarction, Genentech, South San Francisco, Calif.; Genentech is a biotech company
John Freshley. Director, Business ­Development, Statprobe Inc., Ann Arbor, Mich.; Statprobe is one of the nation’s largest privately held CROs
Munish Mehra, Ph.D. Chief Information Officer, Medifacts International, Rockville, Md.; Medifacts is dedicated to providing quality clinical-trial services to ­pharmaceutical, biotech, and ­medical-device companies that are developing cardiovascular drugs and products
Susan Morris, Ph.D. Senior Project ­Manager/National Registry of Myocardial Infarction, Genentech, South San Francisco, Calif.; Genentech is a biotech company
Michael Rosenberg, M.D., MPH. President and CEO, Health Decisions Inc., Chapel Hill, N.C.; Health Decisions is a leading provider of worldwide comprehensive clinical research services to pharmaceutical, ­government, and non-profit organizations
Albert J. Siemens, Ph.D. CEO; Vice Chair of the Board, FHI; president and CEO, ­PharmaLinkFHI, Research Triangle Park, N.C.; PharmaLink was established in 1998 as the first full-service CRO to specialize in “paperless” clinical-trial ­management using market-leading ­­e-technology
Barry Turnbull. VP of Biometrics, CareStat Inc., Newton, Mass.; CareStat provides ­clinical-trial data management; site management; regulatory, manuscript development; and technical and financial expertise