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sponsor's SOPs or the sponsor acquiesces to whatever seems to be the most efficient of the various methods the CRO has developed. But a better solution may be to work closely together to come up with a mix of standardized and customized processes that will best meet the sponsor's needs. This approach, while challenging, can bring together the best of both worlds, to the benefit of both parties. It requires a big commitment to open communication, a strong ability to engage in joint problem-solving, and the willingness to work out, within the new procedural standards, processes for dealing with project changes that occur. |
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VII. Measuring Results: End-of-Study Evaluation of the CRO |
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You have done everything right: the study specifications, the CRO selection, the adaptation to new ways of doing business. So how did it go? To answer that, you must have two things: (a) reasonable expectations for results and (b) performance milestones, set up at the beginning of the process, against which to measure results. |
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The following are some touchstones you might consider using in developing criteria for CRO performance evaluation: |
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performance in meeting stated goals |
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performance on specific services |
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CRO strengths and weaknesses affecting the project |
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actual versus projected costs |
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effective CRO-sponsor personnel communications |
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flexibility in meeting sponsor needs |
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A CRO that does well in all those categories at the end of a study is certainly worth cultivating a continuing close relationship with for work on future studies. If a CRO does not do well, examine why and whether it would be possible and worthwhile to seek improvements in those areas for the sake of possible future projects. |
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Building and maintaining an ongoing relationship with a good CRO can ultimately pay off in improvements in many areas that will benefit the sponsor company. For example, it has been demonstrated that database development cycle times will tend to grow shorter and shorter with every subsequent project on which a sponsor collaborates with the same CRO, as illustrated in Fig. 3. |
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VIII. Beyond the Project at Hand: Long-Term Relationships with Key CROs |
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Contracting in dictates a radical shift in the way sponsors use CROs: the sponsor moves from farming out work based on crisis management to forming a |
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