Auxochromofours Solutions Private Limited How Regulatory Authorities Review SEND Datasets Standard for Exchange of Nonclinical Data (SEND), developed by CDISC, plays a critical role in how regulatory authorities conduct FDA SEND reviews for nonclinical toxicology studies. Pharmaceutical an...
Auxochromofours Solutions Private Limited The Future of SEND - Global Expansion and Digital Submissions SEND's Growing Global Relevance While SEND (Standard for Exchange of Nonclinical Data) originated as a U.S. FDA requirement, its global expansion is accelerating as other regulatory agencies explore t...
Auxochromofours Solutions Private Limited Common Pitfalls in SEND Submissions and How to Avoid Them While the U.S. FDA continues to mandate SEND for nonclinical study data, other regulatory agencies are also taking notice. The European Medicines Agency (EMA) has launched a proof-of-concept pilot (Ja...
Auxochromofours Solutions Private Limited Planning for SEND From Day One: A Complete Guide for Sponsors and CROs In our first post, we explained why SEND (Standard for Exchange of Nonclinical Data) is no longer optional in regulatory submissions. Agencies like the FDA and PMDA now mandate SEND datasets to ensure...
Auxochromofours Solutions Private Limited SEND Isn’t Optional: How to Master CDISC SEND Submissions Think of SEND as the “ official language ” for sharing nonclinical lab study results with regulatory agencies like the FDA (in the U.S.) or EMA (in Europe). If you’ve ever tried to send someone a file...
