Growth in risk-based approaches the 'main challenge' to address in 2020

As we come towards the end of the year, industry experts discuss how the clinical research market has evolved and how they are looking to prepare for the challenges to overcome in 2020. The past year saw CluePoints, a software developer providing clinical trial monitoring services, build on its agreement with the US Food and Drug Administration (FDA) to provide its services supporting the regulator's oversight of the clinical trial market. Asked about how market demands have shifted since 2018, the company's CCO, Patrick Hughes pointed to the ICH E6 (R2) good clinical practice (GCP) guidance, which'became a reality' for sponsors and clinical research organizations (CROs). As a result, this made 2019, "the year in which we have seen the biggest momentum shift across the industry in the adoption of a risk-based approach to trial management," Hughes said. Risk-based quality management in clinical trials focuses on identifying the most important compliance risks in a study and setting them as a priority in order to prevent and avoid potential disruptions.