Novella Clinical utilizes a clinical monitoring model based on one simple principle: every medical device/diagnostic CRA is assigned based on specific medical device experience and location, not on utilization requirements. This ensures better teams, lower turnover within studies, enhanced data currency and quality, as well as CRAs who thoroughly understand both the clinical and regulatory nuances of device/diagnostic trials and the disease state.
Novella’s CRAs are experienced in monitoring all types of medical device trials – from proof-of-concept/feasibility and pivotal to outcome and post-market support studies. Our seasoned CRAs also work closely with our sponsors, clinical specialists and technicians during site evaluations, initiation and interim monitoring visits.
Novella provides options for remote clinical data review in addition to on-site monitoring. This allows for enhanced data currency and better information to make decisions, with cleaner interim data and faster database locks. Our approach also reduces the risk of regional- and country-level protocol interpretation issues and improves signal detection.
Additionally, Novella offers data review by line listings and patient profiles. The review of line listings allows a view of data across all subjects, whereas patient profiles allows a view of a subject’s data across multiple visits, providing an opportunity for Novella to more quickly and efficiently recognize data issues and trends across multiple areas. These tools, with the true focus on the review of study data, provide sponsors with a more complete, robust review of clinical data.