Clinical Outsourcing Strategy: Selecting Partners and Managing Relationships

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Outsourcing can be a cost-efficient means to achieve clinical objectives and ensure a drug's successful path through development. A clinical research organization (CRO) can provide flexibility and expertise to trial sponsors, complementing companies' core competencies. But CRO management will drive up trial costs, delay a drug's time to market, or at worst, lead to a trial cancellation and threaten a drug's future.

Table of Contents :

Executive Summary

Profiled Companies

Methodology and Definitions

Clinical Trial Outsourcing: Five Principles for Success

Clinical Outsourcing Strategy

Top Three Questions to Ask When Setting Outsourcing Strategy

Evaluation of Core Clinical Development Capabilities

A Strategic Bottleneck: Outsourcing Patient Recruitment

CRO Selection and Contract Negotiation

Top Three Questions to Ask a CRO Candidate

Importance of CRO Criteria

CRO Ratings

Managing the Proposal Submission Process


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