Phase Forward Announces FDA Contract Award for Production Rollout of WebSDM™ with Empirica™ Study
News Nov 03, 2009
Phase Forward has announced a contract award to support the FDA’s production rollout of the company’s WebSDM™ Release 3.0 software, including the Empirica™ Study Clinical Trials Signal Detection system.
The WebSDM tool was originally developed under a Cooperative Research and Development Agreement (CRADA) for the FDA to validate and review submission data in CDISC Study Data Tabulation Model (SDTM) format, and has been installed at FDA since 2005. Empirica Study provides advanced statistical screening and visualization tools for review of SDTM data.
Under the contract, Phase Forward will be providing extended support, training, expanded statistical documentation for reviewers, software updates and enhancements to the Center for Drug Evaluation and Research’s (CDER’s) Computational Science Center (CSC) as it works to make standards-based review tools such as WebSDM more readily available to reviewers. The WebSDM solution is also installed at the National Cancer Institute (NCI) for use with the FDA’s Janus data warehouse.
“We’re very pleased to have this opportunity to help CDER expand reviewers’ use of WebSDM to help them more fully realize the benefits of standardized submission data in CDISC format,” said Wayne Kubick, vice president for Phase Forward’s Lincoln Safety Group and Lincoln’s principal investigator for the original CRADA. “Over the past year, we have seen increased interest among reviewers in using Empirica Study’s advanced signal detection capabilities, including Multivariate Bayesian Logistic Regression and its rich set of graphical visualizations with drilldown to facilitate exploration of lab, ECG, vital signs, completion and adverse event data. This new contract will allow us to help reviewers further capitalize on the wider signal detection and analysis capabilities that these products can offer.”
WebSDM, along with the Empirica™ suite of pharmacovigilance and risk management products, is managed by Phase Forward’s Lincoln Safety Group, one of the most experienced and respected teams in the industry.