ROKC’s Clinical Monitoring integrates technology, data, analytics, and expert knowledge to create flexible, customisable solutions. Our risk-based monitoring strategies are tailored for each project and combine onsite, remote, targeted, centralised and statistical methodologies to review study conduct, progress and quality of data.
We employ regionally based monitoring staff with local regulatory and business process knowledge to minimise travel and maximise time at site. Our CRA’s come from life science backgrounds and undergo a comprehensive training programme assuring ICH GCP compliance.
Our Clinical Research Associates will oversee the progress of your study ensuring that conduct, recording and reporting is in accordance with the applicable regulations and ICH GCP. On site and remote monitoring activities, issue escalations, deviation management and follow up are all documented via an online reporting and oversight system.