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d] do you need specific therapeutic experience? |
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e] do you have specific needs for database software? |
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By an examination and agreement on these factors, it should be possible to narrow the number of CROs who offer the services required by your business needs and, thus, reduce the burden of evaluation. |
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The most common way to start evaluating CROs is to devise a questionnaire. This must be done with great care and thought. Too often, these questionnaires ask for excessive information, much of which is irrelevant to the decision making process. The main questions can be clustered under the following headings: |
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a) details of company ownership and business history |
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b) company structure, permanent staff numbers at each site and the distribution across disciplines |
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c) specific trial experience in the areas to be contracted, including details of countries worked in during the last three years, number of studies, number of sites, and number of patients completed |
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d) SOPs currently in use internationally and how international conformity with SOPs is achieved and maintained |
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e) details of project management structure, software, and how international trials are managed |
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f) CVs (anonymous) of potential Project Managers. |
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g) description of data management and statistical analytical procedures and how these are effected for international projects |
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h) description of proposed study requirements and schedule and how they will be met |
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i) software in common use for trial management, data capture, statistical analysis and word processing. |
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Information should also be requested on financial matters including access to the last three years' accounts. |
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The questionnaires need be sent only to those CROs which are expected to meet the company's business needs as agreed beforehand. Knowing which CROs can meet those needs demands considerable knowledge of the industry and, unless the company has an established contracts group, it is probably worthwhile to contact a consultant with the knowledge to help in the selection. Following receipt of the questionnaires completed by the targeted CROs, some can be excluded from further consideration. |
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The next stage involves site visits to conduct audits of the CRO facilities, policies, and procedures. This may seem unnecessary to some but, in |
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