Risk-based Monitoring reduces development time and costs.
Over the last decade, the complexity and cost of clinical trials has increased dramatically. Despite the increased use of electronic data capture (EDC), the industry still has not increased their ability to generate quality data in a productive way. ARG is currently using their technologies to help to evaluate subject safety and protocol compliance in between routine on site monitoring visits. By reviewing data trends across all subjects, ARG is able to evaluate what sites need more time face to face with their monitors.
Our dedicated Clinical Monitoring Team, along with our Trial Site Managers, serves as the liaison between the investigative sites and our client. It ensures that all study volunteer rights have been respected, all study data is complete and accurate, and each investigative site remains compliant with the protocol in accordance with all local and federal regulations. Each ARG Monitor is trained in FDA and ICH/GCP regulations, TrialVista software, and ARG's internal monitoring SOPs. Clinical Monitoring services are available across phases (including post-market analyses), and in proactive communication visits to enhance site relationships and recruitment.