CHI's Risk-Based Quality Management Conference | 29-30 October 2024

Clinical researchers and sponsors are embracing risk-based approaches to quality management and monitoring of clinical studies, but the pathway for implementation can vary depending upon company size, maturity, and culture of innovation. Companies utilizing remote and centralized monitoring strategies are ahead of the curve when study conditions change quickly, particularly when quality is a foundational element throughout the study lifecycle. However, challenges can arise, such as quality oversight of data, data reliability and validation, organizational change management, and regulatory developments. The conference will look at how quality is baked into each element of clinical research, how risk-based approaches are executed by industry leaders and innovators, and how risk-based approaches are received by regulators.