A Digital Way to Exchange Nonclinical Data …And So Much More
Transcript of A Digital Way to Exchange Nonclinical Data …And So Much More
Copyright © 2018 Covance. All Rights Reserved
WHAT IS SEND?
A 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
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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
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Who Developed SEND and Why?
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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?
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2015 2016 2017 2018 2019 2020 2021
Final guidance
issued
New NDA and BLA studies must
comply
Original IND studies
must comply
Defined as protocol finalization
Starts with General Toxicology
and Carcinogenicity Studies
Source: Providing Regulatory Submissions In Electronic Format —Standardized Study Data Guidance for Industry, FDA, CDER, CBER, Dec. 2014
8/2017:US FDA Federal Register Notice of acceptance of
SENDIG v3.1
3/2019: NDA/BLA studies must comply with
SEND v3.1
3/2020: IND studies must comply with SEND v3.1
SENDIG x.x Safety Pharm − CNS DART − FEE − PPND Genetic Toxicology Dermal/Ocular Dataset XML format
BEYOND SENDIG DART 1.0* DART (pending as of Aug 2016)
− EFD
STUDY DATA REVIEWER’S GUIDE nSDRG (v1.0 pending as of Mar 2016)
– Not a regulatory requirement
NEXT
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How Will SEND Requirements Expand Overtime?
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Beginning Dec 2016 General Toxicology
−GLP −Non-GLP −Single Dose −Multiple Dose
Carcinogenicity
Beginning Mar 2019 Safety Pharm – Cardiovascular – Respiratory
SEND 3.0 & 3.1
…and pharmacology will come later
NOT EVERYTHING WAS REQUIRED ON DAY 1 (DEC 17th , 2016)
*SENDIG DART 1.0 has been released by CDISC. The effective date is TBD pending announcement by the FDA via Federal Register Notice that these standards have been accepted into the data standards catalog
What Do I Need To Be SEND-Ready?
THE BASIC REQUIREMENTS TO ACCEPT SEND
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DATA ANALYSIS DATA STORAGE ACCEPT 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
*In Oct 2016, the FDA indicated legacy studies (those started prior to 17 Dec 2016) included in an NDA will require a TS (trial summary) domain in .xpt format with one entry for study start date
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Who Needs to Collaborate for Successful SEND Implementation?
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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
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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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40+ clients
750+ studies
1500+ deliveries
125B+ data points
Get started with SEND today
SEND – Are You Ready?
Or, contact Covance today!
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Need help?
hyperlink in the image above redirects to the Covance online SEND Education Center