Clinical Outsourcing and Partnerships with CROs
Venue: Toronto
Event Date/Time: Oct 27, 2008 | End Date/Time: Oct 28, 2008 |
Description
- Regulatory Compliance Challenges during Outsourced Clinical Trials
- Designing Comprehensive Global Clinical Outsourcing Strategies
- FDA 1572 form – A Contract with the Investigator
- Meeting GCP Regulatory Expectations for Clinical Trials
- Evaluating Proposals and Considerations for CRO Selection
- Regulatory and Legal Framework for Research Misconduct and Fraud
- Developing an Integrated Scalable and Flexible Sourcing Model
- Roles and Responsibilities of the Sponsor
- CRO Contractual and Financial Responsibilities
- Prequalifying a CRO
- Project Management in Outsourced Clinical Trials
- Communication Strategies and Conflict Resolution
- Negotiating a Sponsor – CRO Contract
- Monitoring and Evaluating CRO Performance
- Application of Performance Metrics
- Auditing Clinical Sites for GCP Compliance
Interactive Workshop Session:
- Developing and Writing an Effective Request for Proposal (RFP)