what is send?
TRANSCRIPT
Copyright © 2014 Covance. All Rights Reserved
SEND
A New, Digital Way to Exchange Nonclinical Data
…and so much more
…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 …
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
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
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When Do I Need To Be Ready For SEND?
An Introduction to SEND - May 20165
2015 2016 2017 2018 2019 2020 2021
Finalguidance
was issued
NewNDA and BLAstudies must
comply
Original IND studies
must comply
We are here
Defined as protocol finalization
Startswith GeneralToxicology
and CarcinogenicityStudies
With other study types to come….
Source: Providing Regulatory Submissions In Electronic Format —Standardized Study Data Guidance for Industry, FDA, CDER, CBER, Dec. 2014
SENDIG x.xOcularGenetic ToxicologySafety Pharm− CNSDataset XML formatDART− FEE− PPND
BEYONDSENDIG 3.1Safety Pharm
–Cardiovascular–Respiratory
SENDIG Nonclinical Developmental and Reproductive Toxicology 1.0 DART
−EFDStudy Data Reviewer’s Guide
NEXT
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How Will SEND Requirements Expand Overtime?
An Introduction to SEND - May 20166
SENDIG 3.0General Toxicology
−GLP−Non-GLP−Single Dose−Multiple Dose
Carcinogenicity
BEGINNING DEC 17
…Andpharmacologywill come later
NOT EVERYTHING WILL BE REQUIRED ON DAY 1 (DEC 17, 2016)
What Do I Need To Be SEND-Ready?
THE BASIC REQUIREMENTS TO ACCEPT SEND
An Introduction to SEND - May 20167
DATA ANALYSIS DATA STORAGEACCEPT SUBMITYou 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
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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
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IT TAKES A MULTI-DISCIPLINARY TEAM
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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.
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SEND – It’s Not Only An FDA Requirement, You Can Benefit In Many Ways…
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Data warehousing
Data visualization
Statistical analysis
Historical control data
STANDARDIZATION
Covance is Delivering SEND to Clients Today!
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25+ clients
500+ studies
1300+ deliveries
125B+ data points
Get started with SEND today
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)