The launch of the 12 Days of Christmas campaign marks the start of a festive series of daily insights designed to inform and inspire the diverse pharmacuetical community. Each day, Discover Pharma will feature curated reflections and expert commentary from leading organisations, with CluePoints providing the first insight.

Sophie Henderson, Senior Strategic Consultant at CluePoints, said: “This year we have seen risk-based quality management (RBQM) take center stage in clinical research. ICH E6(R3) emphasized the importance of flexibility, critical thinking and quality-by-design. With regulatory backing and increasing adoption, the industry is learning more about how RBQM can unlock value for drug development and sponsor organizations.”

RBQM is recognised for improving monitoring precision, operational efficiency and cost-effectiveness. In 2025, a critical, sometimes overlooked advantage is its role in proactive site inspection readiness. By offering a smarter, more strategic layer of oversight than traditional methods such as source data verification (SDV), RBQM enables teams to act quickly on emerging risks and supports cross-functional decision making.

Sophie Henderson added: “A critical, and sometimes overlooked advantage, of risk-based approaches is their ability to support proactive site inspection readiness. Risk-based methodologies offer a smarter, more strategic layer of oversight than traditional methods like source data verification. This doesn’t just support operational decision making, it enables informed cross-functional conversations and strengthens inspection readiness across the board.”

Tools such as CluePoints’ Site Profile & Oversight Tool (SPOT) demonstrate how risk-based approaches can be taken further. Integrating key performance indicators into a single interactive view allows sponsors and CROs to prioritise site visits based on actual risk and workload, optimising resources while maintaining full oversight. Every risk signal, site activity and mitigation action is fully auditable, supporting operational efficiency and regulatory readiness.

The 12 Days of Christmas campaign will continue daily throughout the festive period, featuring expert insights, industry best practices and reflections on innovations that are shaping the future of clinical research. This inaugural instalment sets the stage for what will become a flagship, annual series, positioning Discover Pharma as a trusted source for actionable insight.