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Quality

Оглавление

Perfectionism is a feature of our industry. Although absolute quality in all aspects of a clinical trial is never achievable, we continue spending a lot of time and resources to reach it. I think the new edition of GCP, ICH E6(R2), devoted to risk-based quality management should help to overcome this pathological feature to a significant degree.

In addition to this, from the managerial standpoint we should rather think about the level of quality requested by the client than about ideal quality (which, by default, requires unlimited resources and time, which we never have).

Project Management in Clinical Trials

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