|PDS CEO Sayed Badrawi|
IT firm PDS Life Sciences has launched a new service aimed at helping CROs and pharma with their preclinical data submissions to the FDA.
PDS, an New Jersey-based provider of software and solutions for life sciences R&D, has launched "SEND Express" this week in what it describes as a "turnkey solution for the generation of Standard for Exchange of Nonclinical Data (SEND) data sets."
"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," explained 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."
The new service is aimed at helping pharma companies and CROs meet FDA SEND regs without needing to invest in extra software and staff training.
It works by having PDS' preclinical scientists and data analysts use TranSEND, the company's software data translation engine, to speed up data integration and harmonization into SEND-compliant data sets.
The launch of this platform dovetails with the FDA deadline for standardized electronic data submissions. By Dec. 17 this year, all data sets from studies supporting new drug applications, biologics license applications and abbreviated new drug applications must be submitted to the FDA in this SEND format.
- read the announcement