Bioanalytical Systems Details Enhancements to Lab Info Mgmt System

Bioanalytical Systems, Inc. BASI has entered into an agreement with PDS Life Sciences (PDS) to fully upgrade its laboratory information management system (LIMS) to Ascentos™. The new Ascentos software represents the next generation of preclinical research LIMS and is a fully integrated software solution that includes toxicology, clinical pathology, toxicokinetics and pathology modules that streamline data management and reporting. BASi will also implement the TranSEND™ solution as part of the enhancements being made by the company. The new automated software converts study data to the new Standard for Exchange of Nonclinical Data (SEND) format that will be required by the FDA beginning in December 2016. TranSEND effectively aggregates and translates data from multiple LIMS to produce one set of harmonized and validated SEND files as required by the FDA. With this sophisticated tool, BASi will now be able to provide SEND study datasets that are ready for electronic data submission to the FDA without any further processing by the client. BASi President and CEO Jacqueline Lemke said, "Upgrading to PDS' Ascentos and the addition of the TranSEND solution represent vital enhancements to our IT infrastructure that will harmonize data collection and reduce the time to complete a study and deliver our report." Philip A. Downing, vice president of preclinical services at BASi, concluded, "Being able to provide the data in SEND-ready format will shave weeks to months off of clients' timelines since there is no need to do the SEND conversion themselves." "We are very excited to expand our relationship with BASi because the company has always been unique in having both sophisticated lab instrumentation and preclinical research services. Since PDS already has extensive experience in SEND dataset conversion, we look forward to helping BASi become one of the leaders in the CRO field regarding electronic submission compliance. This capability will be a real value added service for BASi clients," said Sayed Badrawi, CEO of PDS Life Sciences. BASi expects final installation of the various modules to be completed this summer with validation testing continuing throughout the rest of the calendar year 2015 and full validation being completed well in advance of the FDA-mandated deadline of December 2016.