Course Description

Partnerships with clinical service providers are critical to the success of a trial. Sponsors, as well as service providers who hire third parties, require both performance and quality oversight. Whether your organization hires different service providers per protocol/program, or you’re in a preferred provider partnership model, you always encounter potential risks. This web seminar will provide a systematic, structured, proactive approach to risk management in outsourced clinical trials based on the revisions in ICH GCP E6 R3. We will discuss the internal and external factors for the organization to identify, assess, manage, and continuously monitor throughout the life cycle of a project and/or partnership.

Learning Objectives

• Identify sponsor’s oversight requirements included in ICH GCP E6 R3 updates
• Describe the attributes of a risk management framework for use in outsourced clinical trials
• Identify potential risk areas with outsourced trials

Who Should Attend

• Sponsor Personnel that choose, manage, or evaluate external service providers
• Vendor/CRO Personnel responsible for trial oversight
• Vendor Personnel that choose, manage, or evaluate other vendor partners

Instructor

Nikki Christison, B.S., C.C.R.A.,T.I.A.C.R.

Click here for complete trainer biographies

Registration Fees

$735*

*Includes up to 20 participants per login at a single location. 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 logins for other locations, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556, or email customer.service@barnettinternational.com for pricing.

Accreditation Information

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 issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-24-054-L99-P.  Released: 8/24. 

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.