iAdvantage Software has enhanced its eStudy electronic study management package in the v5.0 release, with many new features including a built-in statistical analysis and associated visualisation engine in eStudy DataCipher and eStudy Publisher’s ability to simultaneously report data on-demand from multiple databases (Oracle and Sequel) into the same document in just minutes.
eStudy was designed by scientists with years of practical industry experience as a flexible, scalable platform to manage the study rather than the laboratory. Utilising an open architecture with a powerful relational database at its core, users define and control study design, eNotebook design, data collection, analysis and reporting and are not limited by multiple, rigid, stand-alone products that only manage a portion of the study. eStudy supports a wide range of late-stage pre-clinical studies, such as safety, toxicology and efficacy, under GLP and 21 CFR part 11 regulations.
The eStudy Manager component enables study design, eNotebook design and configuration. It allows the user to quickly create studies along with all of the supporting study information: test articles, treatments, test systems, samples, observations, test sites, etc. Role and permission-based functionality allow security of data and increase protection of intellectual property.
eStudy eNotebook is used for study data collection through human and instrument observation. It enables uniform and consistent data collection by investigating scientists from multiple labs or geographies through user-designed web-based templates. Once approved and published to the web, eStudy eNotebooks are hardware-independent and can be used in both online and offline modes.
eStudy DataCipher provides sophisticated query tools and, powered by StatSoft’s webStatistica, provides full-featured statistical analysis and associated visualisations of biological data without the data leaving the security of the eStudy platform and without the user having to learn a new product.
eStudy Publisher can simultaneously access data from multiple data sources (Oracle and Sequel) into the same report, generating reports on-demand in just minutes. Using patent-pending technology, eStudy Publisher allows scientists and business line managers to quickly create report templates. Reports can be generated at the project, study, or site level and presented in user-defined or industry-standard publishing formats. When templates are executed against the eStudy database, reports containing text, tables and images are published into word processing and spreadsheet formats which can be edited at any time or locked for import into document management systems.