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
- 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
- Prepare and conduct a study kick-off
- Measure the performance of your CRO
- Apply Root Cause Analysis (RCA)
techniques to CRO management challenges
- Manage and solve partnership
- Prepare and conduct an end of
- Clinical Research Associates
- Clinical Research Associate Managers
- Clinical Research Professionals with
responsibility for vendor selection and management
- Project Managers
The course will be led by one of the following
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 One: 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
- Expectation establishment: Determine responsibilities, communication expectations, and
planning for the kick-off meeting. Review of regulations and Transfer of
Regulatory Obligations (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.
Two: 8:30 a.m. – 5:00 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
- 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 act
- Identifying CRO issues and concerns
- Development of challenges and
solutions reference tool
- Application of budget management
- Clarifying performance expectations
- Review of metrics, tools and SOP
application to management
- Choosing a CRO and establishing
- Problem solving critical issues/RCA
and CAPA application
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#: 0778-0000-17-012-L01-P.
this course at your company! For more information, contact Naila Ganatra at +1