DESCRIPTION

Involved in clinical trials? We help sponsors and CROs successfully implement ICH E6 (R2), central and risk-based monitoring (RBM). We do this through innovative technology, professional services and change management. TRI developed the first RBQM focused technology - OPRA. This cloud based system for quality oversight, central and risk-based monitoring is so easy to use that anyone in your team can use it. Features like data visualisation, statistical modelling, decision making support, activity management, and time base audit trails help you to improve trial data quality, reduce trial monitoring costs and improve compliance to ICH E6 (R2). It is 21 CFR part 11 compliant, and supports data integration with any EDC, CTMS or open data source. With the recent adoption of ICH E6 (R2), quality and risk management have never been more important or relevant to the way in which we conduct clinical trials. Contact us today to find out how TRI is able to support you in achieving R2 compliance through a risk-based monitoring approach. TRI - Where's The Risk? Contact us today for more information or to book a free demo - info@tritrials.com