WEST LAFAYETTE, Ind., June 7, 2017 (Newswire.com) -
Bioanalytical Systems, Inc. (NASDAQ:BASI) (“BASi” or the “Company”) today announced
its “SEND” compliance with a fully integrated software solution for streamlining data
management and reporting.
In partnership with PDS Life Sciences (PDS), BASi has validated TranSEND™, a submission
solution that allows for the creation of reliable and accurate datasets compliant with the
FDA’s Standard for Exchange of Nonclinical Data (“SEND”) requirements. Submission of SEND
datasets provides faster, higher-quality regulatory reviews that will trim weeks to months off
“We partnered with PDS because they truly
understand the preclinical workflow of laboratories
and the requirements of the SEND initiative,” said
Philip Downing, Senior Vice President of Preclinical
Services at BASi. “The TranSEND™ software will allow
us to provide consistent, high-quality SEND study
datasets that are ready for electronic submission to the FDA without further processing by
the client. This initial investment in SEND technologies promises to deliver long-term
benefits for us and our clients, who can continue to rely on our regulatory expertise as
TranSEND™, PDS’ proprietary software, is designed to generate submission-ready datasets.
“We differentiate ourselves on several fronts. Beyond technical analysis of the SEND
compliant deliverables, PDS guides clients with a scientific level of understanding that
underlies the data, which takes them beyond a SEND compliant dataset to an FDA submission
ready package,” said PDS Life Sciences CEO, Sayed Badrawi. “We were pleased to play a role in
positioning BASi as a leader in the CRO field for electronic submission compliance.”
BASi has also upgraded its laboratory information management system (LIMS) to the PDS
Ascentos™ software solution, making the Company’s entire laboratory information
management as efficient and accurate as possible.
About Bioanalytical Systems, Inc.
BASi is a pharmaceutical development company providing contract research services and
monitoring instruments to the world's leading drug development companies and medical
research organizations. The Company focuses on developing innovative services and
products that increase efficiency and reduce the cost of taking a new drug to market. Visit
www.BASinc.com for more information about BASi.
About PDS Life Sciences
For more than 30 years, PDS has provided intuitive software and solutions for life sciences
research and development programs worldwide. Most of the world’s top 10 pharma
companies rely on PDS software, as do industry-leading CROs, chemical companies,
universities and regulatory agencies. The PDS software lineup is centered on Ascentos™, an
integrated preclinical software data management system, which supports toxicology, clinical
pathology, reproductive toxicology and anatomic pathology. PDS also offers TranSEND™, a
complete FDA submission management solution, and SEND Express™, a dedicated
outsourced service for FDA SEND compliant submissions, as well as powerful bioinformatics
analysis and other services. Learn more at pdslifesciences.com.