Managing Vendors/CRO Oversight to Comply with GCP
Duration: 2 days
Key Objectives:
How to effectively manage CROs/Vendors used in clinical trials to comply with GCP
Build an understanding of your responsibilities as the sponsor: identifying the right level of management and oversight to comply with GCP and regulatory inspectors requirements
Who should take this course?
This course is designed for personnel involved in vendor/CRO oversight (including those
working in clinical research, regulatory affairs, clinical outsourcing, contracts and
outsourcing, clinical quality assurance, clinical quality control, clinical operations,
vendor management, CRO personnel, academic research staff) in the pharmaceutical,
biotechnology industries, contract research organizations (CROs), academic research
organisations and investigator sites.
This course will also help professionals from CROs work more successfully with pharmaceutical,
biotechnology and device companies through gaining a much clearer understanding of their
needs when outsourcing.
Course Syllabus:
1. Introduction and Objectives
2. Background to the CRO industry and meeting regulatory expectations
• Outsourcing today for clinical trials
• Different models of outsourcing clinical trials
• Examine EU and FDA expectations re outsourcing for clinical trials
3. Working effectively with CROs
• Challenges of working with CROs to ensure effective management (group discussion and
sharing experiences)
4. CRO selection – an overview of selection and bidding processes including assessing
the competency the CRO to run a clinical trial
• All or none - What should you outsource?
• Sponsor responsibilities for the clinical study vs the CRO
• Writing the RFP
• Evaluating responses to the RFP
• Pre-Qualification of vendors and vendor audits
• Contract negotiations and partnering with CROs
5. Managing CROs Set up for clinical trials
• Building effective relationship with the CRO while providing sponsor oversight and a
working escalation of issues
• How to set the stage so the CRO focuses on quality and maintain quality of the trial
• Briefing the CRO to be able to successfully run clinical trials
• Clarity of roles and responsibilities
6. Preparation, planning and clarity of roles and responsibilities with CROs
• Project set-up, planning and initiation with CROs for the clinical trial
• Training CROs
• Which SOPs should CROs use?
• Clarity and communications with CROs
• Risk assessment tools
• Tools and techniques for managing CRO performance - Understand the KPIs/
dashboards/report processes that they can set up in order to manage regular meetings
(eg weekly/biweekly or as required) with CROs for the clinical studies
7. On-going Management of CRO continued...
• Tracking and measuring CRO progress and performance
• On-going training and integrating new CRO staff
• Auditing CROs for running the clinical trial activities
• Maintaining effective communication with the CRO
8. Troubleshooting problems with CROs
• Common problems and possible solutions to be discussed in clinical trials where
CROs are used
9. Review of CROs during and at the end of the clinical study
• Review meeting
• Feedback and learnings for future clinical trials using the CRO
