Pharsight Signs Anapharm as PKS™, WinNonlin® AutoPilot™ Customer
ST. LOUIS–(BUSINESS WIRE)–Pharsight, a market-leading provider of software and scientific services to improve productivity and decision-making in clinical drug development, today announced that Anapharm, a PharmaNet company, an industry leader in early-phase drug development, has selected Pharsight Knowledgebase Server™ (PKS™) as its enterprise solution for secure storage and tracking of pharmacokinetic and pharmacodynamic (PK/PD) data.
Anapharm will be the first full-service Contract Research Organization to use PKS as the repository for management, analysis and reporting of PK/PD data generated by the company’s network of Phase I and bioanalytical facilities, as well as for data coming from other sources. PKS will serve as the centerpiece of Anapharm’s PK/PD data management and analysis infrastructure, replacing systems offering limited capabilities to achieve their aggressive strategy in developing a leadership position in Phase I clinical trials.
Under the terms of the license agreement, Anapharm has also licensed Pharsight’s WinNonlin® AutoPilot and PKS Reporter™, both of which are integrated with PKS. WinNonlin AutoPilot is configurable software that research scientists can use to automate common or repetitive tasks during clinical PK analysis and to create report-ready tables and graphs. PKS Reporter is software for creation, management and electronic signature of clinical study reports for internal review and regulatory submission. PKS, WinNonlin AutoPilot and PKS Reporter will be used in conjunction with Anapharm’s existing licenses of WinNonlin®, Pharsight’s industry-standard software for PK/PD modeling and noncompartmental analysis.
“Our ability to quickly leverage our investment in WinNonlin, coupled with additional opportunities for improved analysis workflow efficiency and report quality, were major drivers for our decision to invest in Pharsight’s PKS data repository and reporting solutions,” said Mario Tanguay, Ph.D., Vice President of Scientific and Regulatory Affairs at Anapharm. “We look forward to putting PKS into production, and to utilizing Pharsight’s suite of products to better serve our global pharmaceutical and biotechnology industry customers who demand secure, compliant data tracking and analyses across development programs and indications.”
“Signing a top-tier provider like Anapharm offers further evidence of the value our software products deliver to innovative clinical development services organizations, in addition to pharmaceutical and biotechnology companies,” said Daniel Weiner, Ph.D., Senior Vice President and Chief Technology Officer of Pharsight. “We are delighted that Anapharm has joined the group of prestigious companies selecting PKS, and we are excited about the opportunities to continue to expand our PKS user base in the global clinical services and CRO markets.”
In a separate agreement, Anapharm has also expanded its use of Pharsight’s portfolio of PK/PD analysis and data management tools by licensing Phoenix® WinNonlin®, Phoenix® NLME™ and Phoenix® Connect™. Phoenix® is Pharsight’s new desktop software platform that provides an integrated environment for analysis, modeling and simulation. Phoenix WinNonlin is the next generation of Pharsight’s industry standard software for PK/PD modeling and noncompartmental analysis. Phoenix NLME provides powerful new data processing and modeling tools for population PK/PD analysis. Phoenix Connect integrates applications built on the Phoenix platform with commonly used third-party analysis and modeling tools such as NONMEM®, R®, SAS® and S-PLUS®.
About PKS
PKS is Pharsight’s high-productivity, regulatory-compliant enterprise data repository that manages modeling and simulation data. PKS enables pharmaceutical and biotechnology companies to better manage and control preclinical and clinical PK/PD data and analyses, thus supporting higher modeling productivity as called for in the FDA’s Critical Path Initiative.
Companies also use PKS to build PK/PD data management architecture that complies with the FDA’s regulation 21 CFR Part 11, which has set new standards for computer system validation and usage. PKS is directly integrated with WinNonlin and Phoenix WinNonlin, Pharsight’s industry-leading PK/PD modeling and analysis tool, and supports direct access to any ODBC-capable data source. PKS also supports analysis with leading tools such as NONMEM®, and SAS®, and data import from leading clinical data management and laboratory information management systems such as Watson LIMS™. More information about PKS is available at www.pharsight.com.
About Pharsight
Pharsight, a Certara™ company, is a market-leading provider of software products and scientific consulting services to help pharmaceutical and biotechnology companies improve their drug development process, regulatory compliance and strategic decision-making. Established in 1995, the company’s goal is to help customers reduce the time, cost and risk of drug development, as well as optimize the post-approval marketing and use of pharmaceutical products. Pharsight leverages expertise in its software tools and in the disciplines of pharmacology, drug and disease modeling, human genetics, biostatistics, strategic decision-making and regulatory strategy. Headquartered in St. Louis, Missouri, with more than 1200 customers worldwide, Pharsight products and services are used by all of the world’s top 50 pharmaceutical firms.
About Certara
Certara is dedicated to improving human health through a broad spectrum of products and services, from molecular discovery to clinical research. Formed in 2008, Certara unites Tripos (www.tripos.com) and Pharsight Corporation (www.pharsight.com). Tripos provides innovative scientific solutions enabling life science researchers to improve the efficiency of molecular discovery. Pharsight provides software and scientific services to improve productivity and decision-making in clinical drug development. Certara focuses on reducing the barriers between the phases of research to speed discoveries in chemistry and enable pharmaceutical and biotechnology companies to achieve significant and enduring improvements in the development and use of therapeutic products.
About Anapharm and PharmaNet Development Group, Inc.
Anapharm is the Canadian subsidiary of PharmaNet Development Group, Inc., a global drug development services company that provides a comprehensive range of services to the pharmaceutical, biotechnology, generic drug and medical device industries. The Company offers early and late stage consulting, Phase I clinical studies and bioanalytical analyses, and Phase II, III and IV clinical development programs. With approximately 2,300 employees and more than 41 facilities throughout the world, PharmaNet is a recognized leader in outsourced clinical development. For more information, please visit our website at www.pharmanet.com.
Registered Trademarks and Trademarks
Pharsight, Phoenix, Phoenix WinNonlin, Phoenix NLME, Phoenix Connect, Pharsight Knowledgebase Server, PKS, WinNonlin, WinNonlin AutoPilot, PKS Reporter and Certara are trademarks or registered trademarks of Tripos, L.P. All other brands and product names are trademarks or registered trademarks of their respective holders.
