FDA goes standards-based in review tools

The FDA is rolling out WebSDM Release 3.0 software, originally developed by Phase Forward under a Cooperative Research and Development Agreement. The regulator uses the software to validate and review submission data in CDISC Study Data Tabulation Model (SDTM) format.

The production rollout is the latest step in a process that saw the regulator's initial installation in 2005. The rollout includes WebSDM, which allows users to load SDTM-format study data, check and correct errors and inconsistencies, and browse data in tabular and graphical formats. It helps researchers ensure that submission files conform to the SDTM standard for FDA review. Also included in the rollout is Empirica Study, which provides statistical screening and visualization tools for review of SDTM data.

The contract calls for Phase Forward to provide support, training, expanded statistical documentation for reviewers, and software updates to FDA's Center for Drug Evaluation and Research for its efforts to make standards-based review tools more readily available to reviewers.

WebSDM and the Empirica suite of pharmacovigilance and risk management products are managed by Phase Forward's Lincoln Safety Group.

Separately, Phase Forward announced a multi-year win with Quotient Clinical. The drug development service provider is implementing the InForm global trial management electronic data capture (EDC) solution for data collection, management and analysis. Quotient will also use the Central Designer electronic case report form module.

- here's Phase Forward's FDA announcement [1]
- read Phase Forward's Quotient Clinical release [2]

Related Articles:
Phase Forward emphasizes standards during DIA day 2 [3]
Trial automators skip summer break [4]