FDA SEND Dataset Requirements for Nonclinical Studies

Master SEND data compliance and accelerate drug development

For pharmaceutical R&D professionals, navigating the complexities of regulatory submissions can be challenging, particularly when presenting nonclinical study data. Fortunately,
CDISC SEND (Standard for the Exchange of Nonclinical Data) provides a structured approach to meeting FDA SEND requirements.

This white paper offers an overview of how to submit datasets in the SEND data format, detailing the structure and implementation rules for computer-readable datasets. It also provides valuable insights into how to streamline your submission and avoid common pitfalls, emphasizing adherence to the
SEND implementation guide.

Adherence to FDA CDISC standards improves your chances of a smooth review cycle. Download this white paper for critical guidance.

What you’ll learn

The components of a SEND package and its application in FDA regulatory reviews

The evolving landscape of SEND implementation guides (SENDIGs) and data standards

The requirements for specific study designs, FDA centers, and submission types

About the authors

Peggy Zorn

Senior Director, Product Management

Peggy is the Customer Success lead for SEND Explorer. She has a strong background in nonclinical data management, warehousing and the SEND standard, including serving as the lead of the CDISC SEND controlled terminology team for over 7 years. She continues to be involved in the CDISC SEND team as well as the PhUSE nonclinical working group.

Prior to joining Certara, Peggy worked for 15 years at Pfizer, with 6 of those years focused on nonclinical data management and warehousing. She also worked for INDS for several years, which is the company that originally developed the SEND Explorer dataset reviewer and visualization tool.

Download the white paper

Streamline your SEND submissions and avoid delays. Submit the form below to download the white paper!

About Certara

Certara is dedicated to transforming drug discovery and development for good. We harness the power of biosimulation, advanced analytics, and regulatory expertise to create a future where treatments reach patients faster and more efficiently.

From discovery to market access and commercial, we tailor solutions to meet our clients’ most pressing challenges. Through strategic leadership and advanced predictive technologies, Certara provides comprehensive solutions to optimize drug development processes, reduce risks, and improve outcomes. Our clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries.