News
PDS Releases First Publicly Available, FDA-Validated Dataset for SEND
(Mt. Arlington, N.J., May 20, 2014) — PDS, a leading global provider of intuitive data management software and solutions for life sciences research, announced that it will be the industry’s first provider to make an FDA-validated, preclinical research SEND dataset available to the public free of charge and qualification.
PDS is the developer of TranSEND™, a complete platform-agnostic, Web-based software solution for aggregating and integrating data from multiple laboratory information management systems (LIMS) into SEND-compliant datasets for FDA submission. The dataset can be used by scientists and research organizations across the industry to aid in validation and to serve as an example of a complete and FDA-compliant SEND dataset. PDS has released this anonymized dataset to demonstrate its commitment to advancing the use of data standards.
“PDS is committed to making significant contributions to electronic standards use and development in the noncompetitive space,” said Laura Kaufman, Ph.D., DABT, director of Preclinical Affairs for PDS. “Conformance with FDA validation requirements is mission critical for FDA acceptance and review of SEND submissions.”
PDS posted a link to the dataset on the Pharmaceutical Users Software Exchange (PhUSE) website for use by the community.
With offices on three continents and clients spanning North and South America, Europe and Japan, Swiss-based PDS is a global leader in preclinical data management solutions, with eight of the world’s top 10 pharma companies relying on its software. For more information on PDS’ Ascentos™ preclinical software and TranSEND, visit pdslifesciences.com.
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 pathology. PDS also offers TranSEND™, your complete FDA submission management solution, as well as powerful bioinformatics analysis and other services. Learn more at pdslifesciences.com.
###