Integrated Analytical Software Solutions for Clinical and Regulatory Processes

MasterControl, a provider of integrated software solutions, added three new cloud-based analytical solutions to its MasterControl Version 11.7 software. The eTMF Manager is a software system that automates, centralizes, and standardizes the trial master file process for clinical studies. Registrations, a submission system for product registration and 510(k) device submission management, automates manual or hybrid processes, tracks various requirements globally, and creates transparency for the monitoring of submission bottlenecks. Registrations for eCTD is a publishing software for product registration and electronic common technical documents management. According to the company, these systems are suited to provide clinical managers, as well as regulatory and submissions professionals, the tools and methods needed to improve product time to market.

The updated version includes an analytic engine by JReport, a customizable reporting and business intelligence solution, and allows users to view, filter, and interact with their data more than previous versions of the software. Expanded capabilities include a stylized preview of reports in the form of icons, an interactive editor mode, and two user modes. The editor mode enables users to change column size, add or remove columns, create new data columns for statistics such as percentages and column math, and create new data within the report. Additionally, users can add or subtract columns, images, groupings, summary fields, calculated fields, filters, labels, and graphics.