Since clinical trials and/or noninterventional studies (NIS) represent major investments by pharmaceutical companies and the
choice of a CRO is a crucial success factor for the project, it should be common practice to perform precontract audits at
those CROs in question with which no cooperation is established yet.1 In general, these audits are performed by experienced quality management (QM) employees of the sponsor, who do not always
have a profound background in data management (DM), biostatistics/statistical programming (BIO) or medical writing (MW). Up
to now, these fields, which are only a part of the tasks to be subcontracted, were to some extent neglected in such audits.
This article focuses on aspects to be checked with regard to data management facilities, biostatistics, and medical writing
know-how of the CRO and may serve as a guide for audit activities in these fields.
Questions for the CROA crucial question to begin with is: Has the CRO developed and kept up to date its own standard operating procedures (SOPs)
with regard to DM, BIO, and MW workflows and corresponding interfaces between these functions, and is it willing to provide
these SOPs so that they can be checked by the sponsor. The CRO should also be willing to perform the subcontracted activities
according to the sponsor's own SOPs.
In order to assess capabilities and free capacity, the CRO should provide numbers of clinical trials by development phases
it is currently working on and has worked on in the last 12 months (plus noninterventional studies if applicable).
Figure 1. Important questions to ask a CRO when inquiring about the amount in which they use third parties.
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The CRO should give concise figures to quantify which parts of their activities are subcontracted to third parties—for example,
other CROs or freelancers in the fields of DM, BIO, statistical programming, and MW (see Figure 1).
The CRO should specify the number and qualification of employees in the different functions. Curricula vitae as well as job
descriptions should be available for all coworkers and should be up to date. An important issue is continuing training of
coworkers, and this should be documented by training certificates and/or training logs.
The sponsor should also get an organization chart and information should be given by the CRO regarding fluctuation of employees
(e.g., percentage of employees replaced) in the different functions during the last two years.
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