With the new release, users can import patient data from external clinical databases directly into Genedata Profiler, and exchange sample information bidirectionally with external CROs. For example, users can build subject data cohorts in Genedata Profiler, send selected samples to a service provider for DNA sequencing, then directly save raw sequence data back into Genedata Profiler. This seamless integration saves time and scientific resources, and eliminates data handling errors due to human error.
Furthermore, biomarker and various other omic data can now be processed, analyzed and visualized within Genedata Profiler as well as by external algorithms and tools such as custom R scripts or SAS. Genedata Profiler keeps track of the whole analysis process, including a description of the analytical method, and delivers customizable reports. Patient data, analytics methods, biomarker and omic data, and their derivatives are subject at all times to strict chain of custody controls, ensuring regulatory compliance.
Many researchers work daily with a broad range of data sources and specialized analytical tools. The enterprise integration enhancements offered by Genedata Profiler 12.0 enable researchers to continue to use these data sources and tools, if they choose, while benefiting from any or all of the advanced features and sophisticated data management, processing, analysis and reporting capabilities of Genedata Profiler. Importantly, different members of a project team such as statisticians, clinicians, biologists, and managers need different views on the same data; the new features included in Genedata Profiler 12.0 allow individual team members to use the data in the manner that best suits their needs. The enhanced interoperability does not come at the cost of data governance or security. The software fully maintains the chain of custody of patient data, starting from subjects registered in a study all the way through to the scientific results and conclusions.
In addition to enhanced integration and interoperability, Genedata Profiler 12.0 simplifies and streamlines data update, migration and validation processes. PostgreSQL database management is now embedded in the software, so no commercial relational database management system is required any longer and costs are thus reduced. Data integrity has been boosted, with simplified SSL configuration and migration procedures. This latest version of Genedata Profiler also boasts quality assurance gains, offering a complete set of software validation procedures (IQ/OQ/PQ) together with the corresponding validation data sets.
“With this latest release of Genedata Profiler, we have strengthened its position as the platform of choice for precision medicine,” noted Dr Othmar Pfannes, CEO of Genedata. “The release addresses key requirements of our rapidly growing client base in the biopharma industry, who use Genedata Profiler as the backbone for their clinical and translational research applications. With Genedata Profiler 12.0 we provide a highly flexible enterprise infrastructure that allows scientists to use the analytical tools of their choice in a regulatory compliant computational environment. We are committed to invest further into supporting emerging new technologies in close collaboration with our partners to enable them to bring innovative precision medicines faster and more efficiently to the market.”