Electronic Data Capture Handbook
Strategies and Implementations in Pharmaceutical Research and Development
CRC Press
1st Edition
Published on 15. June 2016
Book
Hardback
360 pages
978-1-4398-1871-8 (ISBN)
Description
Data management is an integral part of the clinical trial process; it not only assures data quality but also ensures the integrity, validity, and consequently the success of the clinical trial. The use of electronic data capture (EDC) has recently received much attention. From technology selection to workflow implementations to warehousing of clinical trial data from multiple sources, this handbook provides the first definitive resource on the factors that are predictive of successful global EDC implementations. Written by experts in the field, the book discusses uses of EDC in clinical data management and details complementary technologies in an overall e-clinical strategy.
More details
Language
English
Place of publication
Bosa Roca
United States
Publishing group
Taylor & Francis Inc
Target group
College/higher education
Researchers in clinical trials and the pharmaceutical industry, biostatisticians, students in biostatistics, and members of regulatory agencies.
Illustrations
100 s/w Abbildungen
100 Illustrations, black and white
Dimensions
Height: 234 mm
Width: 156 mm
ISBN-13
978-1-4398-1871-8 (9781439818718)
Copyright in bibliographic data is held by Nielsen Book Services Limited or its licensors: all rights reserved.
Schweitzer Classification
Persons
Junfang Li is director of the Department of Biostatistics and Programming at Sanofi-aventis Pharma in Bridgewater, New Jersey.
Shein-Chung Chow is a professor of biostatistics and bioinformatics at the Duke University School of Medicine in Durham, North Carolina.
Shein-Chung Chow is a professor of biostatistics and bioinformatics at the Duke University School of Medicine in Durham, North Carolina.
Content
BUSINESS, REGULATORY, AND RISK MANAGEMENT CONSIDERATIONS WITH EDC. TECHNOLOGY FACTORS IMPORTANT IN EDC SELECTIONS. DATA MANAGEMENT WITH EDC. WORKFLOW ALTERATIONS WITH THE EDC IN CLINICAL TRIALS. COMPLEMENTARY TECHNOLOGIES IN AN OVERALL e-CLINICAL STRATEGY.