Genedata, a provider of software solutions for biopharmaceutical research and development, has announced the release of Genedata Profiler 11.0.
The latest development of the software platform delivers new functionality to find patient groups for a given biotherapeutic. The heterogeneous biomarkers identified by Genedata Profiler can be used as patient selection parameters in clinical trial designs.
Identifying highly predictive biomarkers for drug efficacy and drug toxicity is a very important step towards the design of efficient clinical studies and a key success factor for a biopharmaceutical development project.
Genedata Profiler is a first-in-class software platform that automates the identification of selective biomarkers from large sets of omic and phenotypic data for the purpose of clinical trial design. The software also enables scientists to search across clinical studies to identify patients with defined attributes specific to the drug under investigation, and supports trial designers in creating efficient clinical studies with high success rates.
Genedata Profiler also provides built-in chain of custody and audit trails for complete oversight of the provenance of the data. Designed for clinical use and facilitating collaboration between geographically dispersed team members, Genedata Profiler is compliant with all applicable regulations pertaining to use of patient data.
Technically, Release 11.0 is the largest, most comprehensive update in the history of Genedata Profiler, comprising around 700 individual new specific capabilities supporting over 50 new end user end-to-end workflows and over 10 new regulatory controls. A significant addition to Release 11.0 is the new Clinical Subject Data Management Module, designed to integrate and process phenotypic as well as omic data gathered from patients in clinical drug trials. This automated process generates significant savings in time and money for organisations using Genedata Profiler 11.0.
‘We are excited about the latest release of Genedata Profiler, which addresses key requirements in the clinical application space,’ commented Dr Othmar Pfannes, CEO of Genedata. ‘The capabilities provided by the new clinical Subject Data Management Module greatly expand the utility and power of our software, facilitating the development of truly tailored precision medicine. Our clients can now rely on our regulatory-compliant software to produce the benefits of time and cost savings and clear, insightful reporting of results across the entire genomics-based research continuum, from translational through to clinical research.’
