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The RFP: Writing effective requests for proposals in the clinical trial industry

Published by: Integrative Consulting Services

Published: Jun. 1, 2008 - 86 Pages


Table of Contents



PART 1 INTRODUCTION

PART 2 PURPOSE OF THE RFP

PART 3 BEFORE YOU PUT PEN TO PAPER

3.1 ASSESS YOUR OUTSOURCING

3.2 ASSEMBLE RFP TEAM

3.3 PRE-RFP ACTIVITIES

3.3.1 Develop project schedule

3.3.2 Educate RFP team

3.3.3 Develop the budget

3.3.4 Identify CROs

3.4 OPTIONAL: RFP WEBSITE

PART 4 WRITING THE RFP

4.1 ADMINISTRATIVE SECTION

4.1.1 Confidentiality

4.1.2 Background information for the CROs

4.1.3 Logistics of proposal development & submission

4.1.4 Subcontracting

4.1.5 Definition of requirements

4.1.6 Ground rules for proposal content

4.1.7 Ground rules for proposal evaluation

4.1.8 Errors and omissions

4.1.9 Intent to bid

4.2 STUDY REQUIREMENTS

4.2.1 Identifying your requirements

4.2.2 Tips for writing requirements

4.3 PROJECT MANAGEMENT

4.3.1 Project plan

4.3.2 Information the RFP must provide

4.4 CRO QUALIFICATION

4.5 CRO’S SECTION

4.6 PRICING

4.6.1 Comparing one CRO’s budget to another - The bid grid

4.6.2 Payment schedule

4.6.3 Watch out for currency conversions

4.6.4 A note on reverse auctions

4.6.5 A trick to get the best value for your dollar

4.6.6 What if a CRO does not follow your instructions

4.7 LEGAL

4.8 APPENDICES

4.9 EVALUATING YOUR RFP

PART 5 AFTER SUBMITTING THE RFP

5.1 REVIEW INTENT TO BID FORMS

5.2 COMMUNICATION

5.2.1 Documentation

5.2.2 Question & answer

PART 6 EVALUATING PROPOSALS

6.1 EVALUATION START UP

6.1.1 The evaluation team

6.1.2 The evaluation matrix

6.1.3 Preparing for proposal review

6.2 REVIEWING PROPOSALS

6.2.1 First-round eliminations

6.2.2 Second round eliminations

6.2.3 Third round review

6.2.4 Reference checks, site visits & vendor qualification

6.3 EVALUATION REPORT

6.4 POST-EVALUATION ACTIVITIES

PART 7 CONCLUSION

PART 8 ABOUT INTEGRATIVE CONSULTING SERVICES

PART 9 APPENDICES

9.1 CLINICAL PROVIDERS CONSORTIUM’S BID GRID

9.2 FURTHER READING

Table of Figures

Figure 3-1 RFP Process

Figure 3-2 Checklist to shortlist CROs

Figure 6-1 Evaluating proposals

Figure 6-2 Proposal review process

Table of Tables

Table 3-1 RFP Team

Table 3-2 Resources to identify CROs

Table 4-1 Anatomy of an RFP

Table 4-2 Sample of a compliance matrix completed by a bidding CRO

Table 4-3 Details to include in the study requirements section

Table 4-4 Details to include in the project management section

Table 6-1 Sample evaluation matrix for evaluation of a proposal

Table 6-2 Sample scoring matrix for the pricing section of proposal

Table 6-3 Comparing scores of each CRO’s proposal

Table 6-4 Sample breakdown of monitoring requirements

Table 6-5 Sample breakdown of project management review

Table 6-6 Comparison of sample CRO budgets

Table 6-7 Assessing the value of CROs’ quotes


Abstract

You have decided to outsource a component of your clinical study, if not your entire clinical program, to a contract research organization (CRO). In other words, you are taking one of the most expensive processes undertaken by your company, a process upon which the future success of your firm is utterly dependant, and giving it to another company to perform. Given that, it makes sense to put in some effort to ensure the company you hand your clinical trial over to is the best. The cornerstone of this process is the request for proposal (RFP). Our experience shows that many companies experience challenges effectively selecting the best CRO for their project. However, a few companies have developed effective methods to identify and select CROs based on the value they receive per dollar spent. We have developed proposals for over $10 million of clinical trial projects. We have seen RFPs that run the range from extremely poor to exceptional. In this manual, we share with you the secrets great companies use to identify and select CROs to manage their clinical studies.

This manual provides detailed instruction in three areas:
  • Developing an effective RFP
  • Managing the process after you submit the RFP to CROs
  • Evaluating proposals to select the best CRO for your unique needs
By using the principles outlined in this manual, you will gain better control over the entire CRO-selection process. The RFPs you write will be more effective in soliciting proposals from bidding CROs that are easy to review and compare against each other. You will learn how to assess each proposal in an objective manner that will allow you to select the CRO that gives you the best value for your money.

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