hase Forward, the US company that specialises in data management solutions for clinical trials and drug safety, has extended its agreement with the US Food and Drug Administration for use of the company’s WebSDM software in reviewing standardised electronic data submissions from clinical studies.
The WebSDM (Web Submission Data Manager) application was developed under a Co-operative Research and Development Agreement between the FDA and Phase Forward’s Lincoln Safety Group. The software has been in use at the agency since 2004 and is now commercially available to the clinical data management community.
WebSDM allows users to load study data in the Study Data Tabulation Model (SDTM) format developed by the Clinical Data Interchange Standards Consortium (CDISC) as well as check and correct errors and inconsistencies, and browse data in a variety of tabular and graphical formats. The CDISC is a US-based body set up to develop and support global, platform-independent data standards that enable interoperability of information systems to improve medical research and related areas of healthcare.
The follow-on agreement between Phase Forward and the FDA involves technical support for WebSDM use by the agency’s Center for Drug Evaluation and Research review community. WebSDM is also being used by the 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 exploits WebSDM’s load and validation capabilities, and includes a tools integration framework that supports the analysis and visualisation of data in the Janus data warehouse, Phase Forward noted. The extension agreement will give CDER reviewers access to the same version of WebSDM as is employed with Janus, ensuring consistency in the SDTM load-and-validation rules applied to regulatory submissions, it added.
“Now that SDTM is being adopted more broadly, the industry is capitalising on standards-based tools to help ensure data consistency and expand reviewer capabilities to perform advance safety screening, data visualisation and comparative analyses,” commented Wayne Kubick, vice president for Phase Forward’s Lincoln Safety Group.
“We’re pleased to have this opportunity to continue to work with FDA as they begin to more fully realise the benefits of standardised data in supporting the FDA Critical Path Initiative and the ongoing mission to make safe, effective and affordable medical products available to the public.”