Study Management2017-01-16T22:58:56+01:00

Study Management

Risk-based quality management – the new magic phrase in clinical research

The for mid-2017 expected final version of the ICH-GCP guideline addendum takes the subject risk management to the next level: the extent and implementation of a risk-based quality management for a clinical trial no longer remains within the judgement of the sponsor but actually becomes a legal obligation.

By |November 7th, 2016|Categories: Regulatory, Study Management|Tags: , , |