Accelerated regulatory submission pathways established by the US FDA and the EMA – including the FDA’s Fast Track, Breakthrough Therapy, Accelerated Approval, and Priority Review designations, and the EMA’s PRIority MEdicines (PRIME), Accelerated Assessment, and Conditional Marketing Authorisation – offer critical opportunities to bring therapies to patients with serious conditions and unmet medical needs. These pathways, while providing significant benefits, present specific challenges including compressed timelines, heightened regulatory scrutiny, and the need to balance speed with data quality and thoroughness.
Clinical research organisations (CROs) play a pivotal role in helping sponsors success fully navigate these complex pathways. Drawing on their regulatory expertise and specialised capabilities, CROs implement strategic approaches to overcome the inherent challenges of accelerated submissions. This article explores key strategies employed by CROs, including early regulatory engagement, innovative study designs, robust risk-based quality management, efficient document preparation with leveraging technology and streamlined processes, and agile project management. Through these approaches, CROs enable sponsors to meet the demanding requirements of accelerated pathways while maintaining the integrity and quality for regulatory approval.