“PDS is committed to making significant contributions to electronic standards use and development in the noncompetitive space”
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.