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Clincial Ink Releases New ESOURCE Data Transformation Toolset to Streamline Clinical Trial Regulatory Submissions

Andrew Bouldin

Sept. 25, 2014 – Clinical Ink, an innovation-driven eSource solutions company, today announced the release of the SureSource® Data Transformation Toolset (DTT). SureSource DTT automates manual data mapping and transposition processes, delivering submission-ready data faster and minimizing overall clinical development costs and timelines.

"This release reaffirms our commitment to providing innovative eSource solutions that help our customers streamline clinical development from Start to Submit," said Ed Seguine, CEO of Clinical Ink. "Intuitively designed, SureSource DTT automatically maps source data to SDTM to significantly reduce the time and resources required to prepare for FDA submission. SureSource DTT will also simplify third-party system integration and validation by handling system-dependent integration variables more transparently."

SureSource DTT features a drag and drop tool that allows users to pre-define export data domains. SureSource DTT permits users to map data variables, assign data groupings, create complex derivations/calculations, transform code lists, and perform many other previously manual database activities in a validated system with full audit trail and re-usability features. Not only can the data export framework be optimized for the Study Data Tabulation Model (SDTM) required for FDA submission, but SureSource DTT can create multiple simultaneous export frameworks to facilitate third-party system integration via web-services.

Once data is locked, end users select frequency and timing preferences for running final exports (i.e. immediate, scheduled or on-demand). All data exports — including custom templates — are validated and repeatable for data listing, SAS extracts, subject profiles, and SDTM exports.

The SDTM format has gained significant traction in the industry and is the FDAs preferred format for submission of clinical trial data. By 2016, the FDA will require all life sciences companies to provide final data-sets in SDTM format.

About Clinical Ink
Developers of SureSource® the industry’s most widely used eSource platform, Clinical Ink is an innovation-driven eSource solutions company. Our vision is to transform clinical trials from Start to Submit - by creating a completely paperless clinical trial platform. Clinical Ink maintains offices in Winston-Salem, NC and Philadelphia, PA. Additional information is available at www.clinicalink.com.