More than monitoring

Shifts in regulatory expectations, operational models and technological capabilities are transforming how modern clinical trials are conducted, managed and monitored. Clinical Research Associates (CRAs) — the professionals at the centre of clinical trial monitoring and clinical research oversight — are now redefining their role in this transformation. Traditionally seen as operational executors, CRAs are becoming strategic site partners, empowered by data, digital tools, and clinical monitoring technology to drive trial success across  onsite and remote clinical monitoring models.

This whitepaper explores the changing role of CRAs in the context of modern and hybrid clinical monitoring paradigms, including risk-based monitoring (RBM) and risk-based quality management (RBQM) approaches. Based on insights from 132 biopharmaceutical sponsors, this paper examines:

• How evolving CRA roles and smarter site monitoring practices improve site performance and reduce trial delays
• The impact of hybrid and risk-based monitoring models on trial quality, cost-efficiency, and regulatory compliance
• The benefits of mobile-enabled CRAs, intelligent monitoring models, and integrated dashboards for real-time oversight
• How to drive stronger CRA–site partnerships and improve site relationship management to accelerate enrolment and enhance compliance

Whether you are planning a global Phase III clinical trial, implementing decentralised clinical trial models, or optimising oversight for remote and central monitoring, this whitepaper offers actionable insights to support smarter, technology-enabled and AI-driven clinical monitoring decisions.