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Clinical Trial Design for Medical Devices May 2010

May 5, 2010
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Course Description

This course addresses the practical issues in the design of medical device trials and protocol development, as well as broader issues related to clinical trial design and interaction between FDA and sponsors to provide clear direction to support marketing of the medical device.

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Learning Objectives

  • Address the ethical considerations involved in conducting clinical trials
  • Strategically plan for successful clinical trials
  • Develop trial objectives and hypothesis testing
  • Evaluate basic statistical issues relating to sample size 

Who Should Attend

  • Clinical, Regulatory, and Development Staff from medical device manufacturers or Contract Research Organizations (CROs) who will be involved in the design of clinical trials and have responsibility for protocol development
  • Project Managers who have little or no clinical trial experience
  • Project Team Leaders who will be designing clinical trials

Instructor

Douglas Albrecht, B.S.N., C.C.R.A.

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Course Length Time

 2 hours; 1:00 – 3:00 p.m. Eastern
Course Dates

May 5, 2010

Hold this course at your company!

For more information, contact Naila Ganatra at (215) 413-2471

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PublicationsPUBLICATIONS

2012 GCP Question & Answer Guide Print Edition 

2012 Good Clinical Practice Question & Answer Guide Electronic Edition 

CFR/ICH GCP Reference Guide 2012 (Spiral Bound) 

CFR/ICH GCP Reference Guide 2012 (Perfect Bound) 

PAREXEL's Bio/Pharma R&D Statistical Sourcebook 2012/2013 (Hard Copy)