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
- 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
Debbie Harper, B.Sc., P.M.P.
Click here for complete trainer
biographies
$735
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.
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.