Risk-Based Quality Management (RBQM) delivers better clinical trials, improved patient safety and Good Clinical Practice (GCP). Yet many organizations struggle for lots of reasons. Getting Senior Management buy-in; previous initiatives that failed to deliver the promised benefits; using unsuitable tools, such as Excel or generic stats packages; lack of trained staff; and the difficult task of changing the organization, it’s people, processes, and business model, in order to be successful. Having delivered over 150 RBQM projects for Sponsors and CROs, we understand the challenges, and how to overcome them. We’re partnering with big global players such as Worldwide Clinical Trials and Clinipace, and specialists such as Alimentiv. The reason they want to work with us, and what makes us unique, is our operational focus. We know that to deliver RBQM successfully, it must help Operations, the people actually delivering the trial, or it just won’t work. We hire RBQM operational experts from around the world. People with real-life experience of delivering clinical trials. Our industry leading RBQM software (OPRA) has been designed and developed by Operational experts to combine Risk Assessment, Risk Management and Central Monitoring, all in one easy-to-use platform. OPRA, combined with our specialist training and high levels of support, means we can tailor RBQM solutions specifically for your company. If you have an expert team, then we’ll set up OPRA and away you go. If you don’t have in-house expertise, then we can help with everything from GCP training to developing bespoke KPIs, KRIa and QTLs for your studies. Quality Management isn’t optional. Regulatory authorities expect to see evidence of it in every trial submission. It’s central to ICH E6(R2) and E8, and the requirement is being strengthened in the upcoming E6(R3) and E8(R1). If you want RBQM to be at the heart of your clinical trials, talk to TRI – we’re not called “The RBQM Experts” for nothing 😊