This course provides an in-depth overview of Contract Research Organization (CRO) evaluation,selection, management, and trouble shooting. Various types of CRO relationships will be addressed including outsourcing to lab vendors,niche specialty providers, data management,and overall study management and monitoring. Beginning with a review of the Request for Proposal (RFP) process, the course will take you through follow-up analysis and debriefing of the CRO partnership.
- Assess the need for a CRO and determination of services
- Analyze approaches for RFPs
- Evaluate the selection and qualification process of a CRO partner
- Analyze budgets for completeness and fair market value
- Determine communication pathways for outsourced providers
- Prepare and conduct a study kick-off meeting
- Measure the performance of your CRO
- Apply Root Cause Analysis (RCA) techniques to CRO management challenges
- Manage and solve partnership problems
- Prepare and conduct an end of project meeting
- Clinical Research Associates
- Clinical Research Associate Managers
- Clinical Research Professionals with responsibility fo vendor selection and management
- Project Managers
The course will be led by one of the following instructors:
Nikki Christison, B.S., C.C.R.A.
Treena Jackson, M.S., C.Q.A., R.A.C., C.S.S.G.B.
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Day 1: 8:30 a.m. – 5:00 p.m.
- CRO Introduction- Review types of CROs, assess the need for services, RFP process, and selection of a partner
- Scope of work and budget review- Evaluate the scope of work assignment and how to evaluate the proposed and expected budget. Discuss common sources of error, fair market value, or problems with expectations. Focus on feasibility techniques for protocol evaluation and site selection to determine the true value of the budget.
- Expectation establishment- Determine responsibilities, communication expectations, and planning for the Kick-Off meeting. Review of regulations and TORO.
- CRO Management- Oversight and review of expectations and delivery for partnership. Strategic, pro-active management plans and activities review. Discussion of Sponsor oversight obligations.
Day 2: 8:30 a.m. – 4:30 p.m.
- Review of Day 1 materials and concepts
- CRO oversight tools, metrics, and SOPs- Practical discussion and examples of tools and metric tracking. Development and recommendations for SOPs in relation to CRO partnerships. Standardization of CRO management and deliverables within a sponsor organization.
- CRO auditing, issues and escalation- Review audit practices and findings. Discuss root cause analysis and identify potential issues. Determine pathway for escalation and CAPA for non-compliance.
- Putting methods into practice–Discuss problem solving approaches and planning for study wrap up and lessons learned. Review case studies and regulatory actions.
- Identifying CRO issues and concerns
- Developing of challenges and solutions reference tool
- Application of budget management techniques
- Clarifying performance expectations
- Review of metrics, tools and SOP application to management
- Choosing a CRO and establishing communication pathways
- Problem solving critical issues/RCA and CAPA application
Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.
Special rates are available for multiple attendees from the same organization. Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings.
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Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 15 hours (1.5 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# 0778-0000-14-013-L01-P. Released: 3/14.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.