ADVISORY/Phase Forward Executives to Present at 21 CFR 11 and The FDA Guidance for Computerized Systems Conference.Business/Technology Editors and Healthcare/Pharmaceutical Writers ADVISORY...Monday (May 21) --(BUSINESS WIRE) Phase Forward
Who: Phase Forward Incorporated, the Pioneer in Proven E-Process
Solutions for Accelerating Global Pharmaceutical Development
What: Dr. Paul Bleicher, founder, chairman and chief scientific
officer of Phase Forward, to Chair the Conference, and Gilbert
Benghiat, director of engineering of Phase Forward, to Present
as Part of a Seminar on, "Archiving Data and Systems."
Where: Washington Marriott Hotel, Washington, D.C.
When: Conference: Monday, May 21 through Tuesday, May 22, 2001
Presentation: Tuesday, May 22 at 11:00 a.m. EDT
Hosted by the Drug Information Association, The 21 CFR CFR See: Cost and Freight 11 and the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. Guidance for Computerized computerized adapted for analysis, storage and retrieval on a computer. computerized axial tomography see computed tomography. Systems Used in Clinical Trials conference will discuss various issues in the design, development, implementation, validation, and deployment of computer systems in clinical trials. Sessions will explore the implementation of clinical trial technology in further detail, such as the principles behind the new FDA Guidance on Computerized Systems in Clinical Trials and the challenges raised by these new technologies and applications. Dr. Bleicher will serve as the program chairperson chairperson Chairman The head of an academic department. See 'Chair.', Cf Chief. for this conference, outlining the conference agenda, which will consist of discussions ranging from clinical information technology, regulatory affairs Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. Regulatory Affairs professionals usually have responsibility for the following general areas: Gilbert Benghiat's presentation, "Electronic Source Documents: Who has Control?" will examine electronic source document technologies, such as Web-based data capture, remote data entry, certified copies those which are made or attested by officers having charge of the originals, and authorized to give copies officially. - Abbot. See also: Copy , and palm pilots. In addition, Mr. Benghiat will discuss the regulatory issues for electronic source data. Dr. 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 A clinical investigator involved in a clinical trial is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under perspective. Before founding Phase Forward, Dr. Bleicher was vice president, Clinical Affairs at Alpha-Beta Technology, Inc. Mr. Benghiat has more than 15 years of experience in bringing software products to market. Prior to joining Phase Forward, Mr. Benghiat managed NetCentric's Internet fax Using the Internet to send faxes. Fax servers accept an incoming fax message and route it to a fax server in the same locality as the destination fax machine. The fax server then makes a local telephone call to send the fax. server development and Internet metering projects. About Phase Forward Phase Forward Incorporated is the pioneer in proven e-process solutions for accelerating global pharmaceutical development. Phase Forward's InForm(TM) software product uses Internet technologies to conduct and manage clinical trials efficiently and effectively. The InForm software product has been used in over 133 clinical trials worldwide. Its software and service solutions allow sponsors of clinical trials to eliminate the need to transcribe To copy data from one medium to another; for example, from one source document to another, or from a source document to the computer. It often implies a change of format or codes. and process traditional paper data forms, to access global clinical trial data in real time, and to begin data analysis almost immediately after the last patient has visited the clinic. Phase Forward believes that use of its InForm software product by clinical trial sponsors has the potential to cut one to two years off the current seven to nine years it takes to bring new drugs to market, enabling them to increase their revenue potential. Phase Forward Incorporated, a privately held company privately held company A firm whose shares are held within a relatively small circle of owners and are not traded publicly. , is headquartered in Waltham, Mass. Additional information about Phase Forward is available at http://www.phaseforward.com. Phase Forward, InForm and InForm Unplugged are trademarks or registered trademarks of Phase Forward Incorporated. All other trademarks may be the property of their respective owners. |
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