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PDS Life Sciences Launches SEND Express™ to Help Companies Convert Data to Meet New FDA Standards
PDS Life Sciences, a leading global provider of software and solutions for life sciences research and development, has announced the launch of SEND Express™, a turnkey solution for the generation of Standard for Exchange of Nonclinical Data (SEND) datasets.
“With our new SEND Express business unit, PDS has created the only organization and service dedicated to providing outsourced SEND-compliant preclinical data packages harmonized and ready for FDA submission,” said Sayed Badrawi, CEO of PDS. “We have created a proprietary ‘data production line’ with quality systems built in to ensure the highest data integrity and the shortest turnaround times in the industry.”
With its own U.S.-based server infrastructure, PDS SEND Express helps pharmaceutical companies and CROs meet FDA SEND requirements without needing to invest in software and staff training. As a virtual extension of clients’ internal teams, PDS’ preclinical scientists and data analysts use TranSEND™, the company’s proprietary software data translation engine, to expedite data integration and harmonization into SEND-compliant datasets. Through the end of March, SEND Express will have been used to successfully transform nearly 100 preclinical datasets for clients across three continents using heterogeneous source data, from PDFs to various LIMs outputs.
The launch of this platform corresponds with the FDA deadline for standardized electronic data submissions. By Dec. 17, 2016, all datasets from studies supporting new drug applications, biologics license applications and abbreviated new drug applications must be submitted to the FDA in SEND format.
To learn more about PDS’ SEND services, including TranSEND™ and Ascentos™, visit pdslifesciences.com. To learn more about the FDA’s data submission guidelines, visit http://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm.
About PDS
For more than 30 years, PDS has provided intuitive data management 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™, your integrated preclinical software solution, which is purpose-built to support toxicology, clinical pathology, reproductive toxicology and anatomic pathology. PDS also offers TranSEND™, your complete FDA submission management solution, and SEND Express™, your virtual team for FDA SEND submissions, as well as powerful bioinformatics analysis and other services. Learn more at pdslifesciences.com.