Many Leading Pharmaceutical Companies Have Seen Great Success by Using CROs to Accelerate the Development of New Drugs

Research and Markets (researchandmarkets.com/reports/c8632) has announced the addition of A Guide to Evaluating and Choosing CROs to their offering.

(PRWEB) November 5, 2004 -- 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.

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

For more information visit http://www.researchandmarkets.com/reports/c8632

Laura Wood

Senior Manager

Research and Markets

press@researchandmarkets.com

Fax: +353 1 4100 980

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