Pharsight, a US-based provider of software and scientific consulting services, has delivered two data analysis tools to the Food and Drug Administration under a Co-operative Research and Development Agreement (CRADA).

The continuing agreement involves supplying the FDA’s Center for Drug Evaluation and Research (CDER) with new software for the analysis, visualisation, storage, reporting and review of pharmacokinetic and pharmacodynamic data from clinical trials. Two such products have now been delivered to the CDER: Phoenix NLME and Phoenix Connect.

The first of these is data processing and modelling software for population pharmacokinetic and pharmacodynamic (PK/PD) analysis. According to Pharsight, Phoenix NLME lowers the barriers to use of population-based modelling while providing cutting-edge tools “that advance the science of drug development”.

Phoenix Connect can enhance the value of common PK/PD modelling tools by removing barriers between them, Pharsight says. For example, it allows users to save work done with different tools under a single Phoenix project file that can be shared, re-run, altered or saved as part of a workflow template for re-use later with other datasets.

Headquartered in St Louis, Missouri, Pharsight was set up in 1995 to help pharmaceutical and biotechnology companies improve productivity and decision-making in drug development.

In September 2008, Pharsight was acquired for around US$57 million in cash by Tripos, a US-based provider of drug discovery informatics products and services, and the two companies were combined under the umbrella of newly formed translational life sciences specialist Certara.

Last July, Certara stepped up its presence and investments in mainland China and Taiwan, selecting Taipei-based genomics and proteomics specialist Tri-I Biotech as sole distributor for the combined Certara offerings in these markets