Standard for Exchange of Nonclinical Data (SEND)

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Standard for Exchange of Nonclinical Data (SEND) 2017-07-04T10:23:05+00:00

STANDARD EXCHANGE FOR NONCLINICAL DATA (SEND)

SEND IGv3.0 Datasets Required for Submission

NDA Submission
Study Initiation Date On or After:

2016-12-17

ANDA Submission
Study Initiation Date On or After:

2016-12-17

BLA1 Submission
Study Initiation Date On or After:

2016-12-17

IND1,2 Submission
Study Initiation Date On or After:

2017-12-17
1except for devices regulated by CBER as biological products under Section 351 of the Public Health Service Act
2except for noncommercial
SEND IGv3.0, is designed to support the following study designs

  • Single-dose general toxicology
  • Repeat‑dose general toxicology
  • Carcinogenicity

SEND IGv3.1, is designed to support the following study designs

  • Single-dose general toxicology
  • Repeat‑dose general toxicology
  • Carcinogenicity
  • Safety pharmacology (continuous monitoring of cardiovascular and respiratory testing)

SEND: Developmental and Reproductive Toxicology v1.0 (Provisional), is designed to support the following study design

  • Embryo-Fetal Development
MPI Research experts are actively involved in SEND standards development and implementation, including participation in the following groups

  • Clinical Data Interchange Standards Consortium (CDISC)
    • Core Team
    • Controlled Terminology
    • Reproductive Toxicology
    • Safety Pharmacology
    • Genetic Toxicology
    • Dermal/Ocular
    • SEND Model Limits
    • Data Conformance Rules
  • PhUSE Nonclinical Working Group
    • Investigating Endpoint Modeling
    • Application of SEND for Analysis
    • Data Consistency: SEND Datasets and the Report
    • Test Submission Forum/Fit for Use Pilot
    • Nonclinical Study Data Reviewer’s Guide
MPI Research experts support the creation of comprehensive SEND dataset packages

  • SEND IGv3.0 SEND datasets
  • Study Data Reviewers Guide (SDRG)
  • Define file (XML, PDF)

MPI Research can incorporate the following data types into SEND datasets

  • In-house collected data
  • Subcontractor data
  • Sponsor data
  • Conversion of subcontractor data

Visit the FDA’s Study Data Standards Resources webpage for more information on electronic data submission requirements.

What is SEND?

The Standard for Exchange of Nonclinical Data (SEND) is a model for the electronic representation of nonclinical individual data intended to guide the organization, structure, and format of standard nonclinical tabulation datasets for interchange between organizations such as Sponsors and CROs, including submission to the United States Food and Drug Administration (FDA).

Why SEND?

SEND provides an electronic data standard that allows data between organizations to be integrated and used more efficiently. The submission of SEND datasets provides more efficient, higher quality regulatory reviews. SEND also allows data warehousing, historical control, and data mining opportunities.

A Leader in the Industry
MPI Research is dedicated to being a leader in the industry by assuring our Sponsors have access to the latest SEND technology. The experts at MPI Research have reduced the production time for SEND datasets by 50%. See how MPI Research provides consistent, accurate, high quality, and compliant SEND datasets.

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