A second draft of CDISC SEND Implementation Guide v3.1 Draft B is now available for a 30-day public comment period. Comments due September 10, 2015.
A second draft of CDISC SEND Implementation Guide v3.1 Draft B is now available for a 30-day public comment period. SENDIG v3.1 Draft B includes new changes from the prior Draft A posting, and is focused on resolving ambiguity in two areas: schedules (e.g., VISITDY) and representation of timing. This review applies only to the changes in sections pertaining to these new sections on schedules and timing. Please use the instructions in the README document contained in the review package to guide your review.
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.