Azelix uses a 21 CFR Part 11 compliant, user friendly data management system to handle both paper CRFs and EDC-based projects, as well as rescue studies. We will deploy a data capture system, build your study database, review and verify data, and provide it in a format ready for submission to regulatory authorities — with database lock always on or before deadline.
We design our data management solutions to exceed your expectations with no unnecessary “extras” or contentious change orders that push deadlines and bloat budgets. When you’re introducing a new treatment or device to the world, data quality is paramount. Azelix leverages state-of-the-art data management technology to crunch large data sets quickly and accurately. We’re the experts in gathering, organizing, analyzing, and formatting clinical data for regulatory submission.