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A Guide to Evaluating and Choosing CROs
Drug and Market Development Publishing, Pages: 190
1 Executive Summary
2 Introduction
Pressures on the Pharmaceutical Industry
Outsourcing versus Contracting Out versus Sourcing
3 What Is a Contract Research Organization?
Definitions
Services Provided
4 Setting the Scene for Contracting Out
Rationale for the Existence of CROs
Spectrum of Available CROs
5 The Pharmaceutical Industry - Coping with the Need To Contract Out
Tactical, Reactive, Piecemeal Contracting
Strategic, Proactive, Thorough Contracting
6 Contract Management/Outsourcing Management - The Roles of Those Involved
7 Working Out a Reasonable CRO Portfolio
Developing Selection Criteria In-House
Objective versus Subjective Criteria
8 Prequalifying CROs
Preparing a CRO Prequalification Cycle
Conducting the Prequalification Visits
Rating the Evaluation Criteria
Conjoint/Trade-off Analysis
9 Specifying the Project/Request for Proposal (RFP)
10 Conducting the Tender Process
11 Evaluating Time and Cost Estimates
Negotiating the Bid
Carrying Out Feasibility Studies
Price - Cost - Value
What is a Pricing Scheme (Pricing Model)?
12 Awarding the Project
Letter of Intent (LOI)
Identifying, Assembling, and Maintaining the 'Dream Team'
Working Towards the Final Contract
13 Preferred Provider/Strategic Partner Relationships
Various Levels of Partnerships
Recognizing the Unequal Nature of Sponsor-CRO Partnerships
Assessing Benefits and Limitations of Partnerships
14 Concepts Related To Outsourcing
Insourcing
Contracting-In
Virtual Structures
Mobile Structures
Site Management Organizations (SMOs)
15 The Way Ahead To Outsourcing
Outsourcing as a Business Option
CRO Growth
CROs in Niches
Medium-Size CROs
16 Appendices
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