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A Guide to Evaluating and Choosing CROs


Description: The pharmaceutical industry is under increasing pressure to develop new drugs. All of this pressure comes at a time of strong and varying competition, complex formulations, and strict clinical practice standards. In addition, the productivity of today's drug discovery technologies has dramatically increased personnel requirements causing many companies to look outside of their organization for help. The market of service providers to the pharmaceutical industry is often difficult to understand. In addition, project management skills applied within a company do not directly transfer to managing an outsourced project. D&MD's Guide to Evaluating and Choosing CROs provides essential guidance for securing the correct outsourcing option. In addition, you'll find the information you need to make the right deal and facilitate co-operation with all partners. This Guide will answer these following questions: - Do I need to seek resources outside of my own organization? - What is a CRO and what services do they provide? - What criteria should I use when evaluating and choosing a CRO? - What is included in a Request for Proposal (RFP)? - What should be included in the final contract? - What payment structure works best for my organization's situation? - What other types of partnerships are available? - How can I make the most out of this partnership? Many leading pharmaceutical companies have seen great success by using CROs to accelerate the development of new drugs. Whether your company is moving products through different phases of clinical trials, handling a new technology that has been licensed in, or trying to keep up with an overflowing research pipeline, the right CRO can catapult you ahead of the competition. Who Should Own this Guide to Evaluating and Choosing CROs? This is an essential tool for any professional faced with the challenge of seamlessly integrating CROs into the clinical development of new drugs. This guide will greatly benefit individuals with the following titles: Clinical Project Manager, Contract Manager, Project Manager, Clinical Study Manager, Head of Research & Development, Head of Clinical Research, Head of Project Management, Portfolio Manager, Business Development Manager, and Controller of External Services.


Contents: 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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