Current Edition

Strategic Advantages of Integrating Regulators’ Advice into Clinical Trial Programme Design

Working closely with regulators should be seen as an important strategy for successful drug development, rather than a barrier to be sidestepped or overcome. Early and frequent consultations with regulators helps to avoid surprises during all phases of clinical development, but particularly in the earlier phases. Bruno Speder of SGS discusses how integrating regulatory advice into the trial programme is an effective approach to mitigate the regulatory risk that is inherent in product development and improve the likelihood of early product approval.