The FDA requires nonclinical data in all submissions for carcinogenicity and general toxicology studies initiated after December 17, 2016, to comply with data standards specifications. Learn more about the new SEND regulatory requirements and how Covance can help you get SEND-ready.

1. Copyright © 2014 Covance. All Rights Reserved
SEND
A New, Digital Way to
Exchange Nonclinical Data
…and so much more

2. …into a
standardized,
electronic dataset
What Is SEND?
SEND = STANDARD FOR EXCHANGE OF NONCLINICAL DATA
An Introduction to SEND - May 20162
SEND
Presents your nonclinical
data in a standard format
to fulfill regulatory eCTD
submission requirement
Packages nonclinical
study
data points …

3. CURRENT STATE SEND STATE
What Led To SEND? A Surprising Finding.
► Consult several different
tables individually
► Search through hundreds
of pages of data
► Use the digital SEND dataset
plus a visualization tool
► View data on one screen to
organize and analyze data
An Introduction to SEND - May 20163

4. Who Developed SEND and Why?
An Introduction to SEND - May 20164
Pharma
CROs
Software
solution vendors
WHY
► Set controlled terminology
► Standardize format
► Enhance data review
► Eliminate data entry by agency
► Enable data warehousing, analysis
and visualization
WHO
Covance is active in the SEND Consortium
and FDA/PhUSE Working Group 6

5. 5
When Do I Need To Be Ready For SEND?
An Introduction to SEND - May 20165
2015 2016 2017 2018 2019 2020 2021
Final
guidance
was issued
New
NDA and BLA
studies must
comply
Original
IND studies
must
comply
We are
here
Defined as protocol
finalization
Starts
with
General
Toxicology
and
Carcinogenicity
Studies
With other study types to come….
Source: Providing Regulatory Submissions In Electronic Format —Standardized Study Data Guidance for Industry, FDA, CDER, CBER, Dec. 2014

6. SENDIG x.x
Ocular
Genetic Toxicology
Safety Pharm
− CNS
Dataset XML format
DART
− FEE
− PPND
BEYOND
SENDIG 3.1
Safety Pharm
– Cardiovascular
– Respiratory
SENDIG Nonclinical
Developmental
and Reproductive
Toxicology 1.0
DART
− EFD
Study Data Reviewer’s
Guide
NEXT
6
How Will SEND Requirements Expand Overtime?
An Introduction to SEND - May 20166
SENDIG 3.0
General Toxicology
−GLP
−Non-GLP
−Single Dose
−Multiple Dose
Carcinogenicity
BEGINNING DEC 17
…And
pharmacology
will come later
NOT EVERYTHING WILL BE REQUIRED ON DAY 1 (DEC 17, 2016)

7. What Do I Need To Be SEND-Ready?
THE BASIC REQUIREMENTS TO ACCEPT SEND
An Introduction to SEND - May 20167
DATA ANALYSIS DATA STORAGEACCEPT SUBMIT
You need the ability
to accept or handle
large files
You need software to
view and use your
SEND dataset
You need the ability to
submit SEND datasets
You need a storage
solution for warehousing
large files

8. 8
Who Needs to Collaborate for Successful
SEND Implementation?
An Introduction to SEND - May 2016
Regulatory Procurement IT Study Teams
Understand submission
requirements
Vendor selection Software validation
and implementation
Nonclinical data production,
scientists and operations
8
IT TAKES A MULTI-DISCIPLINARY TEAM

9. 9
How Does SEND Arrive?
► A zip file arrives via FTP site or
Covance StudyTracker®
► Data types are presented in separate “domains”
(i.e.: Body Weight (BW) data in BW domain)
► Multiple domains make one dataset per study
► The domains are in .xpt format
(readable by SAS Viewer)
► Each dataset has a “define” file explaining
certain details
ARRIVES AS A COPY OF DATA PRESENTED IN FINAL STUDY REPORT
An Introduction to SEND - May 20169
Did you know: A standard SEND dataset for an 8-week rat
toxicology study (4 week treatment/4 week recovery) will be
~ 50,000 data points, 8.7MB file size, with a 7MB final report.

10. 10
SEND – It’s Not Only An FDA Requirement,
You Can Benefit In Many Ways…
An Introduction to SEND - May 201610
Data warehousing
Data visualization
Statistical analysis
Historical control data
STANDARDIZATION

11. Covance is Delivering SEND to Clients Today!
11 An Introduction to SEND - May 2016
25+ clients
500+ studies
1300+ deliveries
125B+ data points
Get started with
SEND today

12. SEND – Are You Ready?
Or, contact Covance today!
An Introduction to SEND - May 201612
Need help? Here are more resources.
► “Data-Driven Decisions” blog (link here)
► “Are you SEND Ready” webinar (link here)
► “SEND – What Can I Expect?” webinar (link here)
► “The Tale of a Real-life SEND Test Submission” blog (link here)
► SEND web page (link here)
► FDA guidelines (link here)