Simulations Plus launches regulatory submissions software
Simulations Plus, a Lancaster, Calif.-based provider of simulation and modeling software for pharmaceutical discovery and development, is expanding its offerings of best-in-class software for pharmaceutical R&D with PKPlus, a new program that provides user-friendly analysis and reporting of clinical trial data for use in submissions to regulatory agencies.
John DiBella, vice president for marketing and sales for Simulations Plus, said, “Many in the industry have been under the mistaken impression that there is only one software program that meets the requirements of regulatory agencies for analysis and reporting of non-compartmental analysis results for clinical trial data. We intend to correct that misconception.
Walt Woltosz, CEO of Simulations Plus and its wholly owned subsidiary Cognigen, said, “We are designing PKPlus to be a friendly but powerful program to satisfy pharmaceutical researchers’ needs while providing better value than alternative programs. The development of PKPlus is an excellent illustration of the synergies between Simulations Plus and our Cognigen subsidiary. We expect a beta release of PKPlus in November, with full release expected in January, but we are announcing it now in order to be able to discuss it at our annual Japan User Meeting for this year in Tokyo tomorrow as well as at the 2015 American Association of Pharmaceutical Scientists Annual Meeting in Orlando, Fla., starting on Oct. 25.”