PDS Life Sciences, a 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.