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FDA Renews Pinnacle 21 as Software Provider for DataFit

Pinnacle 21 announced today that it has been selected to provide custom software and related services to support the FDA’s DataFit program, which serves to expedite the new drug application process.

Plymouth Meeting, PA, September 26, 2015 --( Pinnacle 21, a life-sciences technology company that specializes in optimizing the new-drug development and approval process, announced today that it has been awarded a five-year contract by the U.S. Food and Drug Administration (FDA) to provide software and related services to support its DataFit program. This agreement is a renewal of a similar contract initially awarded in 2011, following the launch of DataFit.

“We are as excited as we are honored to have been selected once again,” said Max Kanevsky, president and CEO of Pinnacle 21. “We greatly appreciate the FDA choosing us to help lead our industry’s shift into the future, which is the all-electronic submission process.”

The DataFit program provides the FDA’s Center for Drug Evaluation and Research (CDER) with a data standards checking platform. DataFit enables CDER to assess data quality and perform data validation for standards compliance of electronic clinical and non-clinical trial study submission data. Pinnacle 21’s software, OpenCDISC Enterprise, enables this through a web interface for the selection of data based on the submission, set of studies, or standalone studies.

DataFit enables reviewers to assess and understand the quality of incoming submission data at a summary level in hours - a process which would otherwise take a reviewer several days or weeks to accomplish during a manual review.

Pinnacle 21 is the developer of the OpenCDISC Enterprise software platform, which has been implemented at FDA for the DataFit program. The DataFit installation of OpenCDISC Enterprise enables the FDA to perform large-scale data validation and data quality reporting, as well as utilize platform management tools. Pinnacle 21 is also providing Operations and Maintenance (O&M) through IT professional services.

CDER launched the DataFit project in 2011 with the goal of enabling its reviewers to rapidly assess whether submitted data was “fit for use” - to make the submission process more efficient and help get important new drugs to market safely and more quickly. Late last year, FDA issued a mandate that studies starting after December 17, 2016, must be submitted electronically and in conformance with CDISC standards. Pinnacle 21’s support of DataFit going forward will be instrumental in enabling that smooth transition for the biopharmaceutical industry.

About Pinnacle 21

Pinnacle 21 is life-sciences technology company dedicated to one thing: maximizing the speed and efficiency of the new-drug development and submission process. With unmatched expertise with CDISC and FDA compliance, clinical data quality and FDA submission readiness, Pinnacle 21 helps new drugs earn FDA approval faster - maximizing their profitability. In 2008, the company’s founders created OpenCDISC Validator, the most widely used open-source software in the biopharmaceutical industry; and since 2011 they have provided the FDA with the software platform used to screen electronic submission data for standards compliance and data quality. For more information, please visit
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Ippolito Media Arts (IMA)
Liz Lattanze

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