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| home > epc > winter 2001 > e-cdm - the complete solution for clinical data management |
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European Pharmaceutical Contractor
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Pharmaceutical clinical trials today place great demands on companies trying to bring medically important drugs to market. Competitive and market pressures and the desire to bring life-saving therapies to patients require faster and more efficient data collection and review. Clinical researchers must also address safety and data integrity issues, which require accuracy and speed in the reporting of clinical data and serious adverse events. Consequently, there must be rapid communication among investigators, monitors, sponsors and potentially, regulatory agencies. In addition, information must be shared with institutional review boards (IRBs) and the data and safety monitoring boards (DSMBs) that are now common in larger trials.
Web-based electronic data capture (EDC) has already begun to have a great impact on the speed and accuracy with which data can be collected and transmitted among the various participants in clinical trials. The next stage in the evolution of the clinical trial infrastructure is the integration and transformation of all the pieces into a new clinical data management system - e-CDM - that starts at the design of the protocol, moving through data capture to analysis and database storage and retrieval. e-CDM is a system that provides end-to-end clinical trial solutions and makes all the data available at every step, to everyone who needs it.
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By Jeffrey Klofft, Vice President/General Manager of Data Management Products, and Paul Bleicher, Chairman and Chief Science Officer, at Phase Forward Incorporated
Jeffrey Kloff is Vice President/General Manager of Data Management Products at Phase Forward. He has more than 15 years of experience in the definition, development, deliver and support of software products. Most recently, Jeffrey was the Vice President of Product Development and Chief Technology Office of Banian Systems, where he oversaw the transition from proprietary network solutions to standars-based, intranet solutions. Prior to Banian, he was the Vice President and General Manager of the Sybase Systems Management Products Group, with an earlier period as a member of the Sybase Worldwide Professional Services Organisation. Jeffrey holds a BSCS and MCSC from Worcester Polytechnic Institute.
Dr Paul Bleicher brings to Phase Forward more than 11 years of experience in the design, implementation and analysis of clinical trials, from both the sponsor and clinical investigator prospective. Before founding Phase Forward, Paul was Vice President of Clinical Affairs at Alpha-Beta Technology, Inc. Prior to this, he served as a Medical Monitor and Director of Early Phase Services at PAREXEL International one of the world's largest contract research organisations. Paul currently serves on the Drug Information Association Steering Committee of the Americas, and the editorial board of Applied Clinical Trials. He trained an Internal Medicine and Dermatology at Harward Medical School and was a Founding Scientist of the Harvard / MGH Cutaneous Biology Research Center. Paul gained his MD and PhD in Microbiology from the University of Rochester.
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