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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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor principal: Abdel-aleem, Salah
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Hoboken, N.J. : John Wiley, ©2010.
Temas:
Medical instruments and apparatus > Research.
Clinical trials.
Clinical Trials as Topic > methods
Equipment and Supplies
Device Approval
Études cliniques.
Médecine > Appareils et instruments > Recherche.
MEDICAL > Instruments & Supplies.
Clinical trials
Medical instruments and apparatus > Research
Acceso en línea:Texto completo
Tabla de Contenidos:
  • 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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