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the selection of a CRO is a daunting process for a pharmaceutical, biotechnology, or medical devices company. |
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Technomark Consulting Services produces a register of CROs listing major facilities, senior staff, and a brief description of the services offered which may be a starting point for companies searching for a CRO. However, the register gives no indication of quality of the service offered. |
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In many pharmaceutical companies, there is little strategy behind choosing a CRO. CROs are used sparingly and the amount contracted varies considerably from year to year. Under these conditions, if a particular CRO has been used before, for example, by the cardiovascular team and has performed a study adequately, then, it will be used again for a similar study in that therapeutic area. Traditionally, a small number of CROs will be used, probably consisting of small, niche, and full service CROs. The decisions to use the CROs will be made by individuals within the company based on personal experience which is commonly limited. This approach can lead to disappointment and dissatisfaction if the CRO has staff changes or is unable to complete the study and can lead to panic and another round of internal information gathering. Often, there has been no attempt to establish a database of experience, and consequently, no coordination is possible when choosing CROs for further studies. This strategy or lack of strategy ensures that many of the benefits of the expertise and scale of performance of CROs are overlooked by the pharmaceutical company. This strategy, thus, penalizes the pharmaceutical company because it will have limited knowledge of CRO costs and performance and will use only the few CROs it works with on a limited number of occasions. |
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A better approach is to determine that a certain proportion of clinical work will be contracted each year and for the company to make a rigorous selection of CROs with whom they will place contracts. The selection is usually made by a team led by the contracts staff in companies which have established such a group or by a Task Force charged with conducting the project. The first task in such an approach is to determine what the business needs are for the particular pharmaceutical company. The business needs are driven by the following generic factors: |
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a] are you intending to contract out full service contracts? |
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b] are you going to contract out international studies and if so across which countries? |
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c] are you contracting out clinical activities and/or data management and biometrics? |
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