We believe in leveraging easy to access EDC software that is intuitive, interactive, efficient and compliant. At Sierra, we have conducted over 40 studies using Merative Zelta™ (formerly IBM Clinical Development) for electronic data capture. The tools we utilize in our EDC system expedite the data cleaning and database lock processes. This system is a favorite among study sites and sponsors; and is both 21 CFR Part 11 and HIPAA compliant.
With the Cognos Smart Reports module, Sierra's DM experts have the ability to generate expansive, customized and filtered reports and metrics that can be delivered to designated study team members via email on a routine schedule. Additionally, our experts can create interactive and highly dynamic dashboards that provide extreme efficiency in trial management. Dashboards available include study management, site performance, monitoring/SDV status, safety & compliance management. They provide a bird's-eye view for study oversight with the ability to quickly click on sections to filter the dashboard or drill down to the details.
The Merative Zelta™ EDC system includes a well-rounded set of standard reporting options including visit schedule reports to quickly identify missed and out of window visits, data trackers to help identity outliers, and listings for more detailed data review. Reports and dashboards are designed and customized per project based on request from the sponsor.