eClinical Trials: Planning and Implementation - Softcover

Kush, Rebecca Daniels; Bleicher, Paul; Kubick, Wayne R.; Kush, Stephen T.; Marks, Ronald; Raymond, Stephen A.; Tardiff, Barbara

9781930624283: eClinical Trials: Planning and Implementation

Softcover

ISBN 10: 193062428X ISBN 13: 9781930624283

Publisher: Centerwatch Inc, 2003

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eClinical Trials: Planning and Implementation

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.

eClinical Trials: Planning and Implementation will be routinely referenced by scientific, administrative and clinical IS personnel when planning and implementing eCT technology strategies.

Book features...

* Understanding how eCT technology solutions can accelerate and improve clinical research processes
* Identifying ways to redesign the research processes in order to optimize the advantages of various eCT technologies
* Considerations for establishing quantitative metrics to measure and track the impact of eCT technology implementation
* Understanding and applying the intent of 21CFR11 and data privacy requirements and the value of data interchange standards
* Comprehending the value of data interchange standards and how to ensure high quality data for clinical trials

Perfect for:

* Investigators, study nurses, pharmacists and other research professionals
* Instructors conducting training and educational programs
* Sponsors, CROs, SMOs and academic institutions conducting clinical trials

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Review:

"...the premiere resource for the broad Electronic Clinical Trials landscape. The chapters are complete, well integrated and readable." -- Charles Jaffe, M.D., Ph.D., Director of Medical Informatics, AstraZeneca Pharmaceuticals LP

"This work...provides clear and insightful vision for integrated systems that share data to support all clinical trial operations." -- Meredith Nahm, Director, Clinical Data Integration, Duke Clinical Research Institute, Board Member, Society for Clinical Data Management

'A truly outstanding and major contribution to drug development...I'm sure the book will fly off the shelves.' -- Dr. Elliot Danforth, Clinical Investigator, University of Vermont

'An excellent and thought-provoking overview.' -- Fergus Sweeney, Ph.D., Principal Scientific Administrator, European Agency for the Evaluation of Medicinal Products

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