Novella Clinical utilizes a clinical monitoring model based on one simple principle: every CRA is assigned based on specific therapeutic or 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 the specific disease state. This knowledge leads to better communication with – and satisfaction from – our extensive site network.

Novella has CRAs experienced in monitoring all types of clinical trials – including immunotherapy oncology, dermatology biologics or pivotal medical device studies. Our seasoned CRAs 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 more informed decision making, 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 us 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.

Clinical Monitoring