By Robin Newman, Chief Commercial Operations Officer at Pro-ficiency
In the tightly regulated domain of clinical research, compliance remains a consistent concern, often seen as a cumbersome and expensive checkbox on the regulatory to-do list. However, the upfront establishment of compliance systems can yield substantial benefits, particularly by minimizing operational disruptions that can blur the distinction between investigational product issues and systemic flaws.
Fundamentally, compliance entails adhering to a set of standards or regulations. In clinical research, this encompasses performance and safety criteria. Such adherence is pivotal in producing a viable product.
Clinical research involves diverse stakeholders, each bearing distinct compliance obligations. For instance, drug and device sponsors must align investigational product creation with GMPs/QSR requirements, and conform to information submission regulations. At this level of site research, IRBs outline standards for their communities, which must uphold ethical norms, specific grant-funded mandates, and internal protocols.
Meeting these obligations optimizes clinical trials' performance, achievement of endpoints, and safe administration of investigational treatments—ultimately ensuring patient well-being. In order to uphold these obligations, teams must be effectively trained and familiarized with compliance systems to ensure the accurate execution of the study protocol. Given the diversity in learning preferences, learn why training should encompass various sensory modalities so that all research staff can understand clearly what has to happen and how it has to happen.