Datafarm Inc., a world leading provider of high performance electronic regulatory submission solutions for the life sciences industry, announced on 1 September 2009 the release of S-Cubed® CRT v3.0 to help ensure sponsor organisations are compliant with the FDA requirements for clinical data submission, and following CDISC standards when preparing the Case Report Tabulations (CRTs) or the datasets sections of a regulatory submission to the FDA.

Clinical Data Interchange Standards Consortium (CDISC) is a global, open, multidisciplinary, non-profit organisation that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata. In order to increase the level of automation and improve the efficiency of the regulatory review process for new drugs, the FDA announced specifications for dataset data definitions using CDISC SDTM standards and requires that all study data must be delivered in an electronic format – even if the marketing application is in paper format.

S-Cubed® CRT v3.0 automatically creates the entire CRT section of an electronic submission along with the define.xml (or define.pdf for legacy data) file, SAS transport files and other related components along with necessary navigational functionalities such as hyperlinks and bookmarks. S-Cubed CRT then verifies and reports on whether or not the included datasets and variables are in compliance with the CDISC SDTM (Submission Data Tabulation Model).

“As a CDISC Registered Solution Provider, we are very pleased to provide our customers with the latest technology in automation and compliance for creating CDISC-compliant CRTs for electronic submissions,” said George Waidell, VP of Product Strategy at Datafarm. “The release of S-Cubed CRT v3.0 is the latest testament to our commitment to help customers navigate the ever-changing regulatory landscape.”

For more information on Datafarm’s CDISC standard based solutions please visit:
www.datafarminc.com/Solutions-CRT.aspx