Dt&CRO

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About Dt&CRO

FDA Full Package Service

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Full Package Service

We dream of future through creative innovation and challenge

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FDA full package service

SEND

Standard for Exchange of Nonclinical Data

  • Big Data Build
  • Fast Data Review
  • Data Reconfirm
  • Efficiency and Convenience
SEND stands for the Standard for Exchange of Nonclinical data,
and the FDA’s eCTD requires all nonclinical data to be submitted in SEND format.
Timeline
From March 15 2020, NDA and IND data should be submitted following SENDIG version 3.1
FDA Timeline of Study Data
  • SENDIG v.3.0

    Single dose, Repeated dose and Carcinogenicity

  • SENDIG v.3.1

    Single dose, Repeated dose and Carcinogenicity
    + Cardiovascular and Respiratory
    (Safety pharmacology)

Single dose, Repeated dose, Carcinogenicity, and Safety Pharmacology test results should be submitted in SEND format following SENDIG version 3.1
Dt&CRO SEND Service

Dt&CRO provides not just dataset conversion but full package of FDA approval with CDISC instructor.

Dt&CRO’s LIMS and SEND Compatibility

Final Report
Dt&CRO SEND conversion
We provide legacy dataset conversion of data provided by other testing facilities using our in-house SEND conversion program.
Dt&CRO LIMS synchronization
Datasets are automatically converted in accordance with existing raw-data, using our own LIMS platform to maintain data consistency.

DT&CRO is the first Korean organization to develop an in-house SEND program,
signing a partnership agreement with the overseas corporation run by a co-author of the CDISC SEND standard.
Our aim is to provide seamless, full-package technology services for domestic
and foreign pharmaceutical and bio ventures for U.S. FDA registration and approval.