FDA Extends Use of Phase Forward’s WebSDM™ Product in the Submission and Review of Clinical Trials Data in CDISC SDTM Format

WALTHAM, Mass.–Phase Forward (NASDAQ: PFWD), a leading provider of data management solutions for clinical trials and drug safety, today announced an extended agreement to support the FDA’s use of the company’s WebSDMTM software. This 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 to continue to work effectively with electronic data submissions in standardized format.

The WebSDM product was developed by Phase Forward’s Lincoln Safety Group in collaboration with FDA during a Cooperative Research Agreement (CRADA). The WebSDM software supports the validation and review of clinical trials study data submitted by bio-pharmaceutical companies in the Study Data Tabulation Model (SDTM) format developed by the Clinical Data Interchange Standards Consortium (CDISC).

The WebSDM product also is being used by FDA with the Janus study data warehouse, which is being developed as a common electronic repository to store CDISC-compatible human and animal study data. The Janus application architecture uses WebSDM’s load and validation capabilities and includes a tools integration framework that supports the analysis and visualization of data in the Janus data warehouse in a variety of ways. WebSDM provides tabular and graphical review and safety signal detection as one of the analysis tools represented in this framework. This extension agreement will ensure CDER reviewers 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.

“Now that SDTM is being adopted more broadly, the industry is capitalizing on standards-based tools to help ensure data consistency and expand reviewer capabilities to perform advance safety screening, data visualization and comparative analyses,” said Wayne Kubick, vice president for Phase Forward’s Lincoln Safety Group and Lincoln’s principal investigator for the original CRADA. “We’re pleased to have this opportunity to continue to work with FDA as they begin to more fully realize the benefits of standardized data in supporting the FDA Critical Path Initiative and the ongoing mission to make safe, effective and affordable medical products available to the public.”