More than monitoring

Shifts in regulatory expectations, operational models and technological capabilities are transforming how modern clinical trials are conducted and monitored, and Clinical Research Associates (CRAs) are at the centre of this evolution. Traditionally seen as operational executors, CRAs are now emerging as strategic site partners, empowered by data and digital tools to drive trial success.

This whitepaper explores the changing role of CRAs in the context of modern monitoring paradigms. Based on insights from 132 biopharmaceutical sponsors, this paper examines:

• How evolving CRA roles improve site performance and reduce trial delays
• The impact of hybrid and risk-based monitoring models on trial quality and cost-efficiency
• The benefits of mobile-enabled CRAs and integrated monitoring dashboards
• How to drive stronger site relationships to accelerate enrolment and improve compliance

Whether you are planning a global Phase III trial or optimising oversight for a decentralised study, this whitepaper offers actionable insights to support smarter clinical monitoring decisions.