Pharsight releases Phoenix NLME and Phoenix Connect

Pharsight, a market-leading provider of software and scientific services to improve productivity and decision-making in clinical drug development, today announced that it has released two new data analysis tools; Phoenix NLME and Phoenix Connect. The tools were developed via a collaborative effort between FDA and Pharsight under Pharsight’s previously-announced Cooperative Research and Development Agreement (CRADA) with FDA’s Center for Drug Evaluation and Research (CDER).

“Pharsight is proud to report that we have now provided Phoenix NLME and Phoenix Connect to FDA under our continuing collaboration.”

“When we entered into this CRADA we agreed to provide the FDA with new software for the analysis, visualization, storage, reporting and review of pharmacokinetic and pharmacodynamic data,” said Daniel Weiner, Chief Technology Officer of Pharsight. “Pharsight is proud to report that we have now provided Phoenix NLME and Phoenix Connect to FDA under our continuing collaboration.”

The Phoenix suite of tools Pharsight has provided will be used by FDA, along with software products from other suppliers, to review clinical trial data, especially for clinical pharmacology and clinical safety reviews. The goal of this collaboration is to ensure that this suite of products helps meet FDA needs for Investigational New Drug Application (IND) and New Drug Application (NDA) data review and analysis.

"This collaboration reflects Pharsight’s mission to provide critical tools that can meaningfully increase the productivity and efficiency of the drug development process," continued Dr. Weiner. "With the increasing costs associated with new drug development, the FDA has recognized the importance of utilizing innovative technologies to accurately assess the safety and effectiveness of potential new therapies. Pharsight believes these tools enable those abilities and looks forward to contributing to a more efficient and robust drug application and review process."