Clinical Outsourcing and Partnerships with CROs

Venue: Toronto

Location: Toronto, Canada

Event Date/Time: Oct 27, 2008 End Date/Time: Oct 28, 2008
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An Interactive Conference with Presentations and Discussions on:

- 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)