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BASi Announces Validated 'SEND' Capabilities and Compliance With FDA's Standard for Exchange of Nonclinical Data


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 client timelines.

“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 requirements evolve.”

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.


 
Posted by: limsfinder on Jun 07,17| Profile| 1-General (no specific category)

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