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.
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
- 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
Douglas Albrecht, B.S.N., C.C.R.A.
Click here for complete trainer biographies
2 hours; 1:00 – 3:00 p.m. Eastern
May 5, 2010
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471