Читать книгу Project Management in Clinical Trials - Alexey Levashov - Страница 6

Project targets include scope, quality, timelines, and cost. Traditionally, it is thought that the client may fix only three out of the four targets maximum. For example, if the client defines scope, quality, and timelines of the project, they may not define its cost – it is to be defined by the CRO. Or, alternatively, if the client says what scope, timelines, and cost they would like to have, they may not dictate what quality should be like.

In clinical trials, in fact, none of the four targets may be really fixed by any of the parties including the client because of the following main reasons:

CROs make assumptions regarding scope better, but there is always room for creepy scope to say nothing about big scope changes at the sponsor’s request;

– Ideal quality is constantly tried to be achieved;

– Timelines are very much dependent on people and organizations including sites, Competent Authorities, Ethics Committees, and so on;

– Only CRO can define the cost.