The CDISC SEND Implementation Guide for Developmental and Reproductive Toxicology Studies is now available for public review. Comments due August 13, 2015.
The CDISC / SEND leadership team announced the opening of the public comment period for the CDISC SEND Implementation Guide – Developmental and Reproductive Toxicology (SENDIG-DART) v1.0 draft. This standard supports study data typically found in embryo-fetal developmental (EFD) toxicity studies and is based on the SENDIG for single-dose general toxicology, repeat-dose general toxicology, and carcinogenicity studies. Future releases will cover other reproductive toxicology study designs.
The document package can be accessed through the CDISC portal. You will need to login or register for a CDISC portal account to provide comments through the CDISC Public Comment Tracker tool. Members of the PDS SEND team were actively involved with the CDISC work stream that developed SENDIG-DART.
PDS has been translating studies to the SEND standard for more than 10 years. We released the first publicly available, FDA-validated SEND dataset, which was generated with our platform-agnostic SEND solution, TranSEND™. TranSEND™ has been used for SEND submissions successfully received by the FDA from PDS clients spanning three continents.
PDS is a provider of software and solutions for life sciences research and development. For more than 30 years, we’ve developed software by scientists, for scientists — a hallmark that is unrivaled in our field. For that reason, eight of the world’s top 10 pharma companies rely on PDS software, as do industry-leading CROs, chemical companies, universities and regulatory agencies. With offices on three continents and clients spanning North and South America, Europe and Japan, we are a truly global company.
Developed by a team that understands the workflow of laboratories and submissions, the PDS software lineup is centered on Ascentos™, our integrated suite of toxicology, clinical pathology, reproductive toxicology and pathology LIM modules, and TranSEND™, our platform-agnostic SEND solution designed to produce submission-ready SEND datasets from any data source.