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fact, it is vitally important. The company staff who conduct the audits must be chosen with great care. They must be discipline-specific to include all areas to be contracted and also include a financially qualified member. Moreover, the team must devote sufficient time to the task and understand the importance of the visit. The sponsor must set the agenda, and forewarn the CRO of documentation desired, e.g., certificates, SOPs, CVs, etc. Access must be requested to all personnel at all levels and to all facilities, and more than one office of the CRO should be visited if possible. |
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Failings of the CROs should be reported back to them if it is decided not to include them in the list of CRO candidates. |
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Then, contracting is concentrated on a carefully selected small number of CROs which can deliver the services required. It should be possible to negotiate so-called umbrella contracts to cover all of the major contractual issues leaving the details of specific studies to be added as addenda. |
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The next logical stage in the CRO-pharmaceutical company arrangement is the preferred partnership into which several major companies have entered recently. This will be discussed in detail in Section IV. |
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The discussion above has dealt largely with pharmaceutical companies which have already contracted out clinical research and have staff experienced in selecting a CRO and negotiating contracts. However, there are a number of companies which have never contracted studies and have no experienced staff. When they are faced with contracting out a series of studies or even one study, they have a difficult time ahead. However, if they follow the steps outlined above it will make their selection process less prone to error. They can also turn to a number of independent consultants to help them through the stages of selection, negotiation, and management of contracts. |
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IV.
Preferred Partnerships |
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In the U.K., a nonprofit company, Partnership Sourcing Ltd., has been set up by the Confederation of British Industry (CBI) and the Department of Trade and Industry (DTI) to increase awareness, knowledge, and the implementation of sourcing partnerships among British companies. A survey conducted by this company of over three hundred companies from all sectors of industry and commerce, including both manufacturing and service sectors, revealed the success of introducing preferred partnerships. Of those companies forming such partnerships, 81 percent were able to improve the service they gave to their customers, 85 percent were able to |
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