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Feeding the masses – a single platform to serve up clinical data that satiates all appetites

Posted by Rich Davies on Apr 1, 2016 5:27:48 PM

Clinical data captured through electronic case report forms (eCRFs) has always required conversion and delivery to data consumers, such as biostatisticians, for subsequent downstream processing. The volume and variety of clinical data is ever increasing as are the stakeholders and systems that want to consume it.  It would be fabulous if our data consumers could all accept the data they need in the same format. Alas the real world dictates that many of these consumers have their own preferences for both content and structure. The once simple data exports of tables for biostatisticians have increased in complexity. Industry standards such as CDISC SDTM have added the need to transpose and manipulate clinical data in the process of data export, not just provide simple tables per unique eCRF in the trial. The ability to link with other complimentary technologies such as pharmacovigilance systems introduces additional file formats (ICH E2B R2 and R3). This requires yet another specialized export that maps data from the eCRF to a unique, complex data standard.  This necessitates an intelligent export to provide relevant clinical data at the time a specific adverse event (AE) occurs. Data Safety Monitoring Boards may require safety-specific cuts of data. Site personnel may want targeted consolidated views of data across eCRFs and patients such as AE summaries or key-endpoint variables for review. Central or on-site monitors may also need targeted, consolidated views of clinical data summarized across sites to review key risk indicators (KRIs) in a world of risk-based monitoring (RBM). It makes sense then that the eCRF system used as the source of so much clinical data is equipped with the capability to aggregate, manipulate, transpose, export, and visualize the data it collects in any of these scenarios or in anticipation of future scenarios that will no-doubt arise. To that end, OmniComm has consistently expanded its TrialMaster® EDC Custom Data Export Utility into what is today a more holistic and comprehensive data delivery solution that supports the granular control of data to diverse consumers. This novel utility removes the need for downstream data wrangling and conversion required by more generic data exports and places traceability for data exports within the EDC design environment. Users can now manage all their diverse data delivery needs from within a single solution that reduces complexity of their operations with associated cost savings.

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Tags: Data Management, Custom Export Utility, SDTM, data warehouse, TrialMaster EDC