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PCG Clinical Service News
BackDecember 7, Uppsala, Sweden

Journal for Clinical Studies publishes our RBQM article

More on risk-based management in our latest article

The recent addendum to GCP guidelines recommends changes to current quality management processes during clinical studies. This includes applying a risk-based approach that must be incorporated from the outset of the study design. In his latest article in the Journal for Clinical Studies (page 18), Gunnar Danielsson reviews the advantages of applying risk-based quality management (RBQM). The good news is that this new way of thinking should allow more focused and cost-effective clinical studies.