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44 - MDC - Medical Sciences and Clinical Research
MDC 130 - Selecting and Managing CROs
| Code | Start Date | Duration | Venue | |
|---|---|---|---|---|
| MDC 130 | 07 October 2024 | 5 Days | Istanbul | Registration Form Link |
| MDC 130 | 04 November 2024 | 5 Days | Istanbul | Registration Form Link |
| MDC 130 | 02 December 2024 | 5 Days | Istanbul | Registration Form Link |
Please contact us for fees
Course Description
This course will provide the participants with the specific methodology and management techniques to successfully outsource pharmaceutical programs that should then be more likely to be completed on time, within budget, and most importantly, with a high level of quality and performance. Participants will learn how the current external and internal forces are shaping the way projects will need to be delivered to be competitive and cost efficient given the dynamics and demands of the industry.
Course Objectives
- Increasing ability to identify and select the right vendor for the right job a
- Learning to write a Request for Proposal (RFP)
- Using RFP to find, evaluate and select the right CRO for the work they need to outsource
- Understanding the methodology for comparing and contrasting vendor responses to the RFP
- Learning techniques for successfully managing CROs and the shared responsibilities required by the sponsor and the service provider
Who Should Attend?
- Personnel in the pharmaceutical, biotechnology, medical device
- VPs, Directors, Managers and other personnel involved in selecting and managing CROs
- Outsourcing department staff
- Purchasing, finance and contract management staff
- CRO administration and management
Course Details/Schedule
Day 1
Introduction to Clinical Research Organizations
- Why outsource?
- What to outsource?
- Non-Clinical, Manufacturing and Clinical CROs
- Outsourcing entire functions
Day 2
Vendor Selection Process
- How to find a CRO
- Criteria for selection
- RFP development
- Ways to compare and contrast before you select
- Evaluating available documentation
- Proposal review and evaluation
- Contract negotiation and award
Day 3
Managing CROs
- Preparation, planning and positioning with CROs
- Study set-up, planning and initiation
- SOPs: your firm and CROs
- Formulating a study plan
- FDA and legal requirements of CROs
- Monitoring and evaluating methods and timelines of CROs
- Clarity and communications with CROs
- Realistic projections for projects, staff and CROs
Day 4
Duties of the CRO, Sponsor and Trial Sites
- Global knowledge: U.S. vs. EU regulations and nuances
- How to ensure compliance with regulations, including
- GMP
- GCP
- GLP
- Auditing
Day 5
- Collaborative tools and techniques
- Legal framework
- Auditing
- Troubleshooting
- Tackling problems and finding effective solutions
