FDA selects Insightful's sequential trial software for use at CDER
The center is responsible for reviewing and validating the assumptions, models and results of clinical trial submissions by pharmaceutical companies and medical institutions for FDA approval of new drugs.
S+SeqTrial uses monitoring and data analysis within a group sequential design to determine whether or not a study should continue. The S+SeqTrial system is designed to enable biostatisticians to evaluate drug efficacy data on an ongoing basis and perform interim analyses. The software, combined with S-PLUS software, offers tools for analyzing and presenting results for FDA reporting and for improving clinical trial design.
"The Food and Drug Adminstration's decision to use S+SeqTrial reflects their recognition of the value of our modern approach to data analysis, which complements traditional statistical software such as SAS," said Shawn Javid, CEO and President of Insightful. "We can help the pharmaceutical industry and the FDA streamline the data analysis process, as CDER has done by using S-PLUS and S+SeqTrial for clinical trial analysis."