Clinical Trial Design for Medical Devices

This web seminar 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 the 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 

$695

Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call 1-800-856-2556 for pricing.

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 2 hours (0.2 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will mail ACPE statements within three weeks of program completion.  ACPE#: 0778-0000-13-004-L01-P. Released: 5/13. 

Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.