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The design and management of medical device clinical trials : strategies and challenges /

Clinical trials tasks and activities are widely diverse and require certain skill sets to both plan and execute. This book provides professionals in the field of clinical research with valuable information on the challenging issues of the design, execution, and management of clinical trials, and how...

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Bibliographic Details
Main Author: Abdel-aleem, Salah
Format: Electronic eBook
Language:English
Published: Hoboken, N.J. : John Wiley, ©2010.
Subjects:
Medical instruments and apparatus > Research.
Clinical trials.
Clinical Trials as Topic > methods
Equipment and Supplies
Device Approval
Online Access: Full text (MFA users only)
ISBN:9781118164617
111816461X
9780470602256
0470602252
9781118164624
1118164628
1283273969
9781283273961
9786613273963
6613273961
1118125452
9781118125458
Local Note:ProQuest Ebook Central
Table of Contents:
  • Front Matter
  • Challenges to the Design of Clinical Study
  • Challenges to Managing the Study
  • Selection of Historic Controls
  • Fraud and Misconduct in Clinical Trials
  • Challenges to the Regulation of Medical Device
  • Challenges of Global Clinical Studies and the CE Mark Process
  • Challenging FDA PMA Cases
  • Bioethics in Clinical Research
  • Glossary of Clinical, CE Mark, and Statistical Terms
  • References
  • Index.
  • Challenges to the design of clinical study
  • Challenges to managing the study
  • Selection of historic controls
  • Fraud and misconduct in clinical trials
  • Challenges to the regulation of medical device
  • Challenges of global clinical studies and the CE mark process
  • Challenging FDA PMA cases
  • Bioethics in clinincal research.

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