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tation of the specifications, the depth of experience of the CROs, and the business strategy of each CRO vary in responding to the ballpark request. Sponsors must be prepared to accept substantial budget revisions as initial assumptions are modified in the final project plan. |
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In contrast to the preliminary ballpark estimate, sponsors may request a preliminary quotation, based on highly definitive criteria, to appoint a CRO at an early stage in the project. In such a situation, each CRO candidate is expected to prepare a definitive project implementation plan and budget quotation based on the specified criteria. Accordingly, the sponsor can compare the proposals and select a CRO before the final project plan has been defined. In fact, a sponsor may require the specific expertise and resources of the selected CRO to finalize the plan prior to implementation. In such a scenario, the CRO is expected to prepare a final budget quotation after the project plan and scope of work are fully defined. |
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CROs have also come to understand that sponsors may obtain preliminary, yet definitive, quotations in deciding whether to utilize in-house or CRO resources for a project. Although CROs may not be delighted with this practice, they must recognize that a sponsor's internal resources are a competitor, as are other CROs, for most projects. |
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VII.
Preparing a Fully Costed Proposal |
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Upon receiving a request for a proposal from a sponsor, each responding CRO should assure that they fully understand the specifications. If not, the sponsor should be contacted for clarification. Most sponsors are prepared to provide additional essential information if requested. Indeed, in some instances, the sponsor advises all CRO candidates of important clarifying information even though only one CRO has made the request. This helps to assure the sponsor that the proposals are directly comparable. |
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Although the proposal and budget quotation, in all likelihood, is not the only criterion used by the sponsor to select the CRO, they are pivotal. Accordingly, the proposal should be of high substantive and organizational quality, and the budget estimate must be objective and easily understood. At a minimum, the winning proposal must convincingly present the CRO's |
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relevant therapeutic experience, |
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staff and, where appropriate, consultant expertise, |
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relevant project operational experience, for example, specific processes and systems for handling Phase I or large scale (> 50 centers, > 1000 patients) studies, |
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