FDA awards DataFit software contract to Pinnacle 21

September 23, 2015


Pinnacle 21 is pleased to announce that we’ve been awarded a renewed contract to provide software and services in ongoing support of the FDA’s DataFit program.

According to the FDA’s Center for Drug Evaluation and Research (CDER), which made the decision:

“[Pinnacle 21 is] the sole owner, seller and developer of the OpenCDISC Enterprise software that performs the data validation for the DataFit program. DataFit validation of electronic clinical and non-clinical study submission data is a mission critical component of the FDA’s JumpStart service. DataFit is also the FDA program of record for standards compliance and data-quality evaluation of electronic submission data. The DataFit custom installation version of OpenCDISC Enterprise enables the FDA to perform large scale data validation, data quality reporting, and utilize platform management tools … [and] Pinnacle 21 is the only source capable of providing the enterprise level of support and services needed.”

The length of the contract is five years, which will extend the relationship that began in 2011 with the launch of DataFit.

CDER’s goal in launching the program was to enable its reviewers to rapidly assess whether the data submitted with new drug applications (NDAs) was “fit for use.” Pinnacle 21 was tapped at that time to customize its OpenCDISC Enterprise software to drive the program.

The greater goal of all of this? To make the submission process quicker and more efficient, to help get important new drugs to market safely and more quickly.

Late last year the FDA announced that studies starting after December 17, 2016 must be submitted electronically and must contain study data in conformance with CDISC standards. Pinnacle 21’s ongoing partnership with FDA CDER will be instrumental in enabling that smooth transition for all of us in the biopharmaceutical industry.

We at Pinnacle 21 are both thrilled and humbled to have been selected once again, and look forward to the important work ahead.

If you have any questions about Pinnacle 21, OpenCDISC Enterprise, or our work with the DataFit program, please email us.


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