This course provides an in-depth overview of Contract Research Organization (CRO) management, starting with reviewing of bids through follow-up analysis and debriefing of the CRO partnership.
Qualify CROs for your particular project
Specify study requirements to optimize project results
Appreciate the significance of a partnership with your CRO
Prepare and conduct a study initiation meeting
Measure the performance of your CRO
Solve problems
Conduct an end of project meeting
Clinical Research Coordinators, Clinical Research Associates, Data Managers, Project Managers who are changing roles from in-house study management to outsourcing projects with CROs
Personnel who have significant interactions with CRO staff
The course will be led by one of the following instructors:
Natalie Currie, B.Sc
Click here for complete trainer biographies
Day 1: 8:30 a.m. – 5:00 p.m.
- The Outsourcing Industry: Examine the reasons for the establishment and growth of the outsourcing industry; define roles of various outsourcing partners; understand CRO usage patterns and recent outsourcing trends; define the issues that can arise when using CROs; explore issues that can arise from both sponsor and CRO sides of the relationship
- Qualifying CRO Candidates: Understand the importance of outsourcing philosophy and policy; how to construct a CRO database; appreciate the importance of performance metrics in selection of a CRO; understand the RFP process; how to evaluate bids and proposals; appreciate the different types of contracts and agreements between sponsor and CRO
Day 2: 8:30 a.m. – 4:30 p.m.
- Establishing the Partnership: Learn techniques to enhance sponsor-CRO partnership; learn techniques for establishing effective communication; understand the importance of performance metrics and performance projections in managing a CRO; learn how to construct a productive kick-off meeting
- Monitoring and Evaluating the Partnership: Establishing and monitoring project tracking; getting the project reports needed;productive project meetings; managing with performance metrics; productive CRO audits; problem solving; planning and participating in an end of study meeting; applying learning;supporting long-term partnerships
Identifying CRO Issues and Concerns
Clarifying Performance Expectations
Choosing a CRO and Establishing Communication Pathways
Problem Solving Critical Issues
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 Elizabeth Andrews 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 mail ACPE statements within three weeks of program completion. ACPE# 0778-0000-11-004-L01-P. Released: 2/11.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.