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4. Data Management and Analysis (list specific activities) |
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5. Other (specify) |
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E. Milestones and timelines |
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1. Approve protocol |
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2. Obtain institutional review board approvals |
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3. Hold multi-investigator meeting |
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4. File regulatory submission |
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5. Ship clinical supplies |
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6. Complete 25% of the projected patients |
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7. Complete 50% of the projected patients |
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8. Clean up all data |
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9. Approve integrated study report |
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Clear and carefully thought out study specifications are of inestimable value to both the sponsor and the CRO. They can help the sponsor assess internal needs, identify cost and time issues, and establish criteria for CRO selection. They can help the CRO become familiar with project goals, break down tasks for line-item bidding and timelines, and choose the appropriate format for responding to an RFP. Most importantly, they can provide a standard by which to evaluate a CRO and a benchmark by which to measure the CRO's performance during the project. For all these reasons, it is imperative to develop study specifications early and to supply them to all the key playersboth within the company and at the CROas quickly as possible. |
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Once study specifications are complete, the sponsor can begin to prepare a list of potential CROs, using whatever resources are available for preparation of such a list, from existing databases to recommendations of colleagues. |
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With basic information about CROs in handsize, facilities available, areas of therapeutic experienceit should be fairly simple to use the study specifications to eliminate those which do not meet the most basic criteria, such as those which are not large enough to handle a project, or do not have the facilities to carry out key aspects of the project, or have no experience in the therapeutic area on which the project focuses. |
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Once those CROs that are clearly unsuited for the project are eliminated, the sponsor can move on to applying the following criteria to determine which CROs warrant an RFP for the project, employing telephone and personal interviews with key CRO personnel, studying CRO literature, and seeking |
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