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problem was foreseen, then, a solution may be found quickly, but, if the problem was not anticipated, an early proposal for resolving it will benefit both parties. |
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If the CRO and sponsor have worked openly and honestly during the development of the contract, then, as long as problems have arisen through circumstances, not from faulty performance by the CRO or sponsor, then, it should be possible to resolve them quickly and amicably. |
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Unfortunately, however, there will still be cases where it is deemed that the problem has arisen because of poor performance by the CRO. In these cases, it is best to work together to resolve the problem. Most agreements will provide a period during which, having received written notice of a deficiency, the CRO will have time to correct the fault. If the fault cannot be rectified to the sponsor's satisfaction, then there may be no alternative but to terminate the contract and transfer the study to the sponsor or to another CRO. This is so time consuming and wasteful that all efforts should be made before this drastic step. |
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Working together before the contract is awarded, being open and honest during negotiation, being prepared to spend the time to manage the contract, and having contingency plans for possible problems should protect both the sponsor and CRO from the results of contract termination. |
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B.
Project Management Within the CRO |
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Objective, continuous review and proactive communication are always the key to dealing with problems in the course of conducting a project. Clinical research involves people and processes which, by definition, are not always predictable. Whether a project is conducted by the pharmaceutical company alone or through a CRO, problems or unexpected challenges will likely arise. This must be acknowledged by the two parties from the outset. Ideally, the entire team, sponsor and CRO included, must be committed to the same goals of success. |
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The project team should be aware of and, in some cases, document the problems anticipated during the project. This exercise includes identifying contingency plans. Whether or not problems have been anticipated, solutions, should be proposed by the CRO when problems occur, rather than simply reporting the event or situation. Moreover, problematic issues should be addressed as soon as possible to minimize negative outcomes and maintain the confidence of the entire team. |
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Pharmaceutical product development, generally, depends on multidisciplinary project teams. Depending on the needs of the pharmaceutical |
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