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input from colleagues. The goal at this point is to obtain general answers in all of the following areas. |
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Alliance potential. Are the CRO's business objectives compatible with those of the sponsoring organization? Is there a basis for mutual benefit in a relationship between the sponsor and the CRO? |
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Comprehensiveness of resources. Does the CRO have the facilities and staff to handle all the different aspects of the project outlined in the study specifications? Do the personnel have the expertise and experience to work as a true extension of the sponsor, rather than just as a vendor? |
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Record of quality service. Has the CRO historically performed to the standards of accuracy, efficiency, and timeliness that the study specifications demand? Is documentation available to support this history? |
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Extent of experience. Roughly how many studies in the therapeutic area being considered has the CRO performed? How many of these studies were of the same type and size as the one the sponsor proposes? |
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The sponsor can then move on to evaluating CROs which meet these basic qualifications. |
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C. Evaluating CRO Proposals and Choosing the Right CRO |
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Choosing a CRO to contract in may be one of the toughest decisions a sponsor will ever make; it does, after all, involve buying something that does not yet exist and that will not exist until the commitment to buy has been made. As such, it is ultimately based on faith and trust, and it unavoidably involves some degree of risk. This material is intended to help show how a sponsor can minimize that risk by taking care to gather as much solid, pertinent information as possible on which to base a decision. |
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In addition to reviewing any proposals or other written materials a CRO submits for consideration, the sponsor should request a visit to the CRO, to get a firsthand look at facilities and conduct on-site interviews with key personnel. Like the development of study specifications, this should be a team effort; sponsor personnel representing different disciplines should visit the CRO as a team, and then split off from each other to conduct one-on-one interviews with their CRO counterparts [9]. |
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The accompanying chart lists general areas of information about the CRO that the sponsor should address in the decision-making process. These categories should, of course, be tailored to the specific situation, and the sponsor should set specific standards for each one. |
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