eClinical Trials: Planning and Implementation [Paperback]

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

Book Description

ISBN-10: 193062428X | ISBN-13: 978-1930624283 | Publication Date: May 1, 2003 | Edition: 1

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

Editorial Reviews

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

Product Details

• Paperback: 200 pages
• Publisher: Centerwatch Inc; 1 edition (May 1, 2003)
• Language: English
• ISBN-10: 193062428X
• ISBN-13: 978-1930624283
• Product Dimensions: 8.9 x 6 x 0.6 inches
• Shipping Weight: 12.8 ounces
• Average Customer Review: 4.5 out of 5 stars  See all reviews (2 customer reviews)
• Amazon Best Sellers Rank: #1,722,285 in Books (See Top 100 in Books)

Customer Reviews

Most Helpful Customer Reviews

5 of 5 people found the following review helpful:

5.0 out of 5 stars An excellent guide!, July 18, 2003

By 

Richard LaFleur (Charlestown, MA United States) - See all my reviews

This review is from: eClinical Trials: Planning and Implementation (Paperback)

"eClinical Trials: Planning & Implementation" is an excellent guide for clinical researchers interested in taking advantage of the electronic techology that is becoming increasingly available. In such a highly-regulated industry, there are a lot of questions before someone moves from the comfortable environment of paper-based clinical trials to the less-familiar ground of electronic records. This book addresses such topics as data quality and data integrity, safety surveillance and IRBs, and the regulatory environment's intent and impact on clinical trials. The material in this book is presented in a way that can help a researcher understand the implications using the new technologies and processes in planning and implementing a clinical trial.

1 of 1 people found the following review helpful:

4.0 out of 5 stars A rare find: accessible and useful, August 12, 2008

By 

Kyle Hart "trahelyk" (Portland, OR) - See all my reviews
(REAL NAME)   

Amazon Verified Purchase

This review is from: eClinical Trials: Planning and Implementation (Paperback)

Given the relative dearth of clear, accessible, relevant literature on applying electronic technologies to clinical trials, this book is a rare find. It begins with a comprehensive and easy-to-understand overview of the clinical trial process and then methodically moves through the process of applying electronic data capture and other electronic technologies to existing workflows. It paints a realistic picture, giving credence to the advantages of using EDC and CTMS while including frequent reality checks, acknowledging the relative infancy of these technologies. I used this book as a part of my study curriculum for preparing for the Certified Clinical Data Manager (CCDM) examination, and I believe it helped immensely. I especially recommend the book if you're preparing for that exam.