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specific plan for managing, designing, and implementing the project including a clear description of relevant capabilities, resources, information management systems and special technologies, such as remote data entry, interactive voice response systems, etc., |
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quality assurance plan, |
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client communication and reporting plan, and |
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itemized budget estimate. |
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The proposal can be interpreted as an example of the quality of a CRO's services. Therefore, it is imperative that this document is submitted on time, addresses all sponsor specifications, is well organized, easily readable, and complete, yet succinct. |
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Proposals and budgets may be prepared via different means and individuals among CROs. However, in most instances, experts within functional groups or departments (for example, medical, regulatory, biostatistics, etc.) will be requested to provide specialized technical information for incorporation into the proposal. These professional experts should also be capable of projecting the types and quantities of human resources required for each task. These projections typically form the basis for detailed, objective budget preparation by expert budget or financial analysts. |
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The process of proposal and budget preparation may progressively become automated as experience grows within a CRO. When this occurs, each proposal should continue to receive appropriate professional input and review to assure accuracy, completeness, and sensitivity to the sponsor's requirements. To facilitate the retrieval and documentation of a CRO's therapeutic experience and staff expertise for multiple proposals, it is important for the CRO to develop user-friendly, relational databases of the company's study experience and staff expertise. |
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For many of the larger CROs, some form of automated project budget preparation has become essential to handle over a thousand quotations annually. These methodologies may also interface with human resource, project management, financial tracking, and sponsor reporting tools activated by project award and implementation. |
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Before a sponsor awards the work to any one of the responding CROs, generally, proposal presentation meetings are arranged by the sponsor with each of the competing CROs which appear most appropriate for the project based on the submitted proposals and, possibly, reference or other historical information. These sessions are critical in the selection process in terms of the substance of the discussions and the participants. Ideally, the client should visit the short-listed CROs to meet as many of the key, potential |
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