This follow-on agreement, which involves technical support for the WebSDM software for use by the FDA Center for Drug Evaluation and Research review community, will help the FDA to continue to work effectively with electronic data submissions in standardized format, the company said.
The WebSDM product was developed by Phase Forward’s Lincoln Safety Group in collaboration with the FDA during a co-operative research agreement. The WebSDM software supports the validation and review of clinical trials study data submitted by biopharmaceutical companies in the study data tabulation model format developed by the Clinical Data Interchange Standards Consortium (CDISC).
The WebSDM product also is 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.
Wayne Kubick, vice president for Phase Forward’s Lincoln Safety Group, said: We’re pleased to have this opportunity to continue to work with the 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.