Novella Clinical utilizes a clinical monitoring model based on one simple principle: our seasoned global oncology CRAs are assigned based upon oncology experience (tumor type) and location. This ensures better teams, lower turnover within studies, enhanced data currency and quality, as well as CRAs who thoroughly understand the specific oncology disease state. This knowledge leads to better communication with — and satisfaction from — our extensive network of oncology sites.
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, we offer 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 us to more quickly and efficiently recognize data issues and trends across multiple areas. These tools, with a true focus on the review of study data, provide sponsors with a more complete, robust review of clinical data.