FDA e-data review in next Phase Forward

FDA extends use of Phase Forward’s WebSDM software in submission and review of electronic CDISC format data

Amy Swinderman
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ROCKVILLE, Md.—The U.S. Food and Drug Administration (FDA) last month signed an agreement with Phase Forward Inc. for the continued use and support of the data management solutions provider's WebSDM software, a product completed in 2004 under a Cooperative Research and Development Agreement (CRADA) between the FDA and Lincoln Technologies, a Phase Forward company.

According to Phase Forward, the follow-on agreement, which involves technical support for the WebSDM software for use by the FDA Center for Drug Evaluation and Research (CDER) review community, will help the FDA work effectively with electronic data submissions in standardized format. The software supports the validation and review of clinical trials study data submitted by biopharmaceutical companies in the Study Data Tabulation Model (SDTM) format developed by the Clinical Data Interchange Standards Consortium (CDISC).

The FDA also uses WebSDM with Janus, a common electronic data repository for CDISC-compatible study data being developed jointly by the FDA and the National Cancer Institute (NCI), to provide tabular and graphical review of data and safety signal detection. Under the extended agreement, CDER reviewers will have access to the same version of WebSDM that is used with Janus to ensure consistency in the SDTM load and validation rules applied to regulatory submissions.

The extended agreement will help the FDA to better use standardized data to support its Critical Path Initiative and bring safer and more affordable drugs to market, says Wayne Kubick, vice president for Phase Forward's Lincoln Safety Group and principal investigator for the original CRADA.

"The FDA has expressed a commitment to increase their capabilities to conduct a thorough safety analysis and review," Kubick says. "We're pleased to have this opportunity to continue to work with the FDA and greatly appreciate their continued confidence in our products."

Because WebSDM was developed at Phase Forward's cost, the company has commercialized it. Phase Forward has more than a dozen large sponsors, biotechs and CROs who use the software to load SDTM-format data, check and correct errors and inconsistencies and browse data in a variety of tabular and graphical formats, Kubick says. The company updates the software with new versions of CDISC standards to keep in sync with industry advances. These customers also can integrate WebSDM with Phase Forward's EDC, clinical data management and pharmacovigilance tools, Kubick says.

"The FDA's needs are somewhat different from the rest of the industry because they are looking at things from a different perspective," Kubick says. "There weren't many commercial products being developed that provided the capability to face all the regulatory challenges they are currently dealing with. Because we get to work very closely with FDA reviewers, we can create a solution for our customers in the marketplace to help them work more effectively and cooperatively with the FDA to deliver safer, more effective new therapies to the market." DDN

Amy Swinderman

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