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CDISC SEND FAIR data guide

Aishwarya Balajee   |     |  Read Time 10 mins

Abstract

Collectively called the Standard for Exchange of Nonclinical Data (SEND). the standards have been in development and recommended since early 2000s by Clinical Data Interchange Standards Consortium (CDISC) and the FDA.

They are now a requirement for preclinical studies started after December 2016 for New Drug Applications (NDA) and 2017 for Investigational New Drug (IND) submissions.

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    Who is this analysis report for?

    • Toxicologists, Pathologists, Bioanalysts and others involved in creating data for in-vivo/animal studies
    • Those responsible for submission of INDs or NDAs of in-vivo studies

    What you will get out of this report?

    • Learn how CDISC SEND standardization and FAIR go hand-in-hand
    • Understand the benefits of FAIRification of data
    • Typical challenges to look out for in your standardization journey
    Author Image

    ABOUT THE AUTHOR

    Aishwarya Balajee

    Head of Digital Solutions, North America Passionate about accelerating Science. Helping customers define and implement a Digital Strategy Expertise - Strategic consulting across R&D spectrum

    Author Image

    ABOUT THE AUTHOR

    Rimgaile Lukosiunaite

    Business System Analyst at Zifo RnD Solutions for a big pharma client in North Chicago. She holds a dual BS in Biology and Exercise Science from Loyola University of Chicago and a MS in Biotechnology from Northwestern University. Rimgaile took courses in Pharmaceutical, Biotech and Medical Device Business Management, Marketing & Strategy from Kellogg School of Management during her MS program. Rimgaile has worked on various projects in Instrument Data Integrity Remediation, Gap Analysis and Validation & Qualification Activities. Over the last year, she has led implementation of regulatory standards on non-clinical data submissions at a big pharma company.

    Author Image

    ABOUT THE AUTHOR

    Aishwarya Balajee

    Head of Digital Solutions, North America Passionate about accelerating Science. Helping customers define and implement a Digital Strategy Expertise - Strategic consulting across R&D spectrum

    Author Image

    ABOUT THE AUTHOR

    Rimgaile Lukosiunaite

    Business System Analyst at Zifo RnD Solutions for a big pharma client in North Chicago. She holds a dual BS in Biology and Exercise Science from Loyola University of Chicago and a MS in Biotechnology from Northwestern University. Rimgaile took courses in Pharmaceutical, Biotech and Medical Device Business Management, Marketing & Strategy from Kellogg School of Management during her MS program. Rimgaile has worked on various projects in Instrument Data Integrity Remediation, Gap Analysis and Validation & Qualification Activities. Over the last year, she has led implementation of regulatory standards on non-clinical data submissions at a big pharma company.