Publications for Clinical Research Professionals
eClinical Trials: Planning and Implementation

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A new publication focused on the application of technology products and services to enable the life sciences R&D value chain in pharmaceutical, biotechnology, healthcare, government and academic research organizations, spanning basic research, drug discovery and development, clinical trials, and regulatory compliance. Your free subscription also includes new & analysis, special reports, buyer's guides, website access, and free enewsletters such as eCliniqua - comprehensive coverage on the technology advancing clinical trials.

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This new manual - the first-of-its-kind - is an invaluable resource designed to assist biopharmaceutical companies, CROs and investigative sites in understanding, planning and implementing electronic clinical trial (eCT) technology solutions to accelerate and improve their research operations. Written by highly respected and authoritative thought leaders in the field today, this 200+ page book describes and addresses the concepts and complexities of managing and conducting an optimal eCT, while offering practical guidance, facts and advice on implementing eCT technologies.

www.centerwatch.com/bookstore/pubs_profs_eclin.html


EDC: Today’s Realities, Tomorrow’s Possibilities
A program sponsored by an educational grant from PPD

In November 2002, Clinical Data Interchange Standards Consortium (CDISC), CenterWatch and PPD, Inc. held a symposium exploring the current and projected usage of EDC in drug development and the challenges the industry faces in expanding adoption.
A distinguished panel—representatives from sponsors, CROs, and sites—exchanged ideas on adoption complexities, current and expected uses of technology solutions, and challenges that must be addressed in order for EDC technology solutions to be more widely adopted.
Moderated by Ken Getz, president and CEO of CenterWatch, the symposium was divided into three primary sessions.

1) Leveraging EDC technology to meet user needs
2) Reasons for delays in industry-wide EDC adoption
3) Critical success factors for EDC in the future

Transcripts from these primary sessions are available as individual reports through the CenterWatch Online Bookstore. Proceeds for these reports support CDISC.


Click here for more information or to order EDC: Today’s Realities, Tomorrow’s Possibilities.



View the Glossary


This glossary represents terms and definitions that have been proposed by the CDISC Glossary Group for official adoption by CDISC. This glossary contains terms developed by CDISC that are specific to CDISC activities and also certain terms that have been excerpted from industry glossaries for the purpose of presenting a more comprehensive set of terms relevant to the CDISC mission. Following the CDISC terms, there are terms related to CDISC data models, which are grouped under the header for each model, and also general terms pertaining to clinical research, which are listed alphabetically at the end of the glossary. With respect to the terms defined or developed by CDISC, any member of the industry is invited to send comments, questions or proposed definitions to swilliams@cdisc.org.

With respect to the terms we have excerpted from other glossaries, we are open to definitions you may feel would be preferable for these terms and the respective sources; however, we obviously cannot modify those listed from the specified sources (i.e. sources other than CDISC). Additional terms we should add are also welcome suggestions. We appreciate your comments towards achieving a useful glossary for all involved with CDISC.

 

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