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Faster SDTM conversion for clinical trial submissions

Jul 7, 2016 12:00:00 AM





Ed Chappell

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Faster dataset conversion.

Formedix, a leading provider of clinical trial automation software and services based on CDISC standards, has announced the launch of its dataset conversion service. This is welcome news for contract research organizations, pharmaceutical and biotechnology companies faced with regulatory requirements for CDISC standardized electronic submissions.

In December 2016, the Food and Drug Administration (FDA) submission regulations changed. Submissions must now be in an electronic format, and must use the appropriate FDA-supported CDISC standards, formats and terminologies. Organizations can easily adapt to these regulatory changes by using our dataset conversion tool. The service converts datasets from one structure to another. For example, Formedix converts proprietary datasets exported from an EDC system, into CDISC Study Data Tabulation Model (SDTM) datasets, ready for submission.




SDTM dataset conversion in Formedix

Traditionally, proprietary datasets from an EDC system are manually reprogrammed into SDTM datasets, not once but twice, to reduce the margin of error. This is a laborious task and the skills involved are difficult to come by. Double programming is no longer needed, with our SDTM conversion service. This not only improves the quality of SDTM dataset deliverables, it also reduces the time to submission. Any preclinical or clinical proprietary source dataset can be converted to SEND or SDTM formats with ease.

“There were four key drivers for the development of our dataset conversion tool: regulatory change, data quality, time and cost,” said Darren Bill, Head of Operations at Formedix. “With the pace of regulatory change rapidly increasing, we saw the need to create a service that would help clients be CDISC-compliant. We’ve streamlined the method for producing data traceability reports and mapping specifications, as well as automating the data conversion process. We’ve improved the quality of submission deliverables and, as a result, the time to produce SDTM datasets is now 60 percent faster than traditional methods.”

Dataset conversion is part of the Formedix platform, which ensures that submissions are of a higher quality, and can be delivered more quickly and easily than before.

Find out more about Formedix dataset conversion here.


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