Managing Risks in Outsourced Clinical Trials: Practical Approaches and Tools
Partnerships with clinical vendors are critical to the success of the trial. Sponsors, as well as vendors who hire other vendors, require both performance and quality oversight. Whether your organization hires different vendors 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. We will discuss the internal and external factors for the organization to identify, assess, manage, and continuously monitor throughout the life of a project and/or partnership (e.g., protocol, investigational plan, regions, sites, vendors, and resources).
- Describe the attributes of a risk management framework for use in outsourced clinical trials
- Identify sponsor’s oversight requirements included in ICH GCP E6 R2
- 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
Marla Hoelle, B.S.N., R.N., C.C.R.A., ACRP-PM., P.M.P.
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 +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.
Note: Due to COVID-19, we understand that most teams cannot currently dial-in together. As such, we are able to offer additional logins at a highly reduced rate. Please contact Barnett Customer Service at +1 781.972.5400 or toll-free in the U.S. 800.856.2556 to register with your additional participants requiring login credentials. Or email Customer Service at: email@example.com
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 1.5 hours (0.15 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#: 0778-0000-20-042-L01-P. Released: 4/20.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.