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project team members as possible and evaluate facilities, SOPs and applicable technologies and systems. Although CRO visits at sponsor facilities are more convenient and cost-efficient for the sponsor in the short run, they are likely to be less informative to the sponsor and, perhaps, most costly in the long term if the wrong CRO is selected because of insufficient insight into the CRO's infrastructure, expertise, systems, and operating philosophies. |
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Ultimately, the winning CRO will have convinced the sponsor to make the selection, in large part, based on the proposal and quotation submitted, the caliber of the project team, the quality and content of the face-to-face meeting(s), demonstrated project-specific experience and systems, past project performance, financial stability of the company, and reference checks. |
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In summary, the winning proposal and associated discussions will have |
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identified the key personnel for the project,
defined the details of the activities to be carried out,
agreed on task distribution between sponsor and CRO,
established and agreed explicit timelines,
agreed on a definitive budget structure to avoid unexpected extra costs,
considered time and cost efficiencies while assuring quality,
established performance targets,
established communication channels and frequencies, and
assured that all sponsor specifications have been addressed. |
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VIII.
Actions Following Proposal Award. |
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A.
Actions Within the CRO |
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CRO selection may require one to three months, possibly delaying the initiation of a project. To avoid any further delay, the sponsor and selected CRO must negotiate a contract promptly or, at a minimum, agree to proceed under a letter of intent. |
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Sponsors, who outsource considerable amounts of work, often have prototype contracts available which define standard terms and conditions for CRO services. Alternatively, the CRO may propose an initial draft to begin the negotiation. In either case, assuming that the parties agree with the proposed contract terms and the proposal can readily be incorporated into the contract via reference, the project can get underway immediately. |
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In the event that contract development extends beyond the project start date, a letter of intent often suffices to initiate the work. Such a letter typi- |
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