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to ensure that, at the evaluation, negotiation, and implementation stages, the commitment is clear and open. |
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At the CRO selection stage, the business needs of the client company must be defined and agreed to by all groups affected by the partnership. These business needs can vary considerably from seeking a partner for Phase I only, a partner for a single development project, or Phase II/III only for European studies to full service for the U.S.A., Europe and beyond. Agreement on these needs makes the selection and evaluation much easier because the target CROs will be different in each case. The level of outsourcing to be contracted must also be defined and agreed upon. CROs must be made aware of the amount of work to be contracted so that they can plan for staff and facilities required by the partnership. |
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Most important of all is that the partnership must be managed. There must be a commitment by the CRO to dedicate staff to work closely with the client and also a commitment of the client to dedicate staff to manage the partnership. As discussed in earlier sections, open, honest communications are essential to the smooth running of contracts, and this is even more important with a partnership. It is essential that combined planning meetings be held at specified intervals and that the progress of the partnership is monitored at the operational and strategic levels. |
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Several CROs have entered into preferred partnerships with clients, and some pharmaceutical companies and biotechnology companies have publicly announced the formation of such agreements. However, there is little published on the success of these arrangements within the pharmaceutical clinical research area, but, because other industries have documented benefits, it would be odd, indeed, if this were not so in the pharmaceutical industry. Over the next few years, we will learn whether the benefits expected have been generated. |
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Some observers have suggested that a preferred supplier relationship could make a CRO less willing or able to serve a sponsor which has not entered into such an agreement with the CRO. In fact, this is very unlikely in the current, highly competitive CRO marketplace. Each CRO must give each sponsor equivalent attention and a high standard of service to achieve and build success. CROs understand that small, early phase studies can grow into much larger, long-term projects and, therefore, demand focused attention. Moreover, no CRO, with or without a preferred provider agreement, wants to become too dependent on any one or even a few clients because major projects can easily fail or a sponsor's business strategies may suddenly change, leaving a highly dependent CRO vulnerable to an important, sudden loss of revenue. |
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