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Copyright © 2016 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 - Dec 2016 2
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 - Dec 2016 3
Who Developed SEND and Why?
│ An Introduction to SEND - Dec 2016 4
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
When Do I Need To Be Ready For SEND?
│ An Introduction to SEND - Dec 2016 5
2015 2016 2017 2018 2019 2020 2021
Final guidance
was issued
New NDA and BLA studies must
comply
Original IND studies
must comply
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
SENDIG x.x Safety Pharm − CNS DART − FEE − PPND Genetic Toxicology Dermal/Ocular Dataset XML format
BEYOND SENDIG 3.1* Safety Pharm (issued 07 Jul 2016)
– Cardiovascular – Respiratory
SENDIG DART 1.0* DART (issued 17 Aug 2016)
− EFD Study Data Reviewer’s Guide, SDRG (v1.0 issued 03 Mar 2016–not a regulatory requirement)
NEXT
6
How Will SEND Requirements Expand Overtime?
│ An Introduction to SEND - Dec 2016 6
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)
*SENDIG 3.1 and SENDIG DART 1.0 have 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
│ An Introduction to SEND - Dec 2016 7
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
8
Who Needs to Collaborate for Successful SEND Implementation?
│ An Introduction to SEND - Dec 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
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 - Dec 2016 9
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
SEND – It’s Not Only An FDA Requirement, You Can Benefit In Many Ways…
│ An Introduction to SEND - Dec 2016 10
Data warehousing
Data visualization
Statistical analysis
Historical control data
STANDARDIZATION
Covance is Delivering SEND to Clients Today!
11 │ An Introduction to SEND - Dec 2016
40+ clients
750+ studies
1500+ deliveries
125B+ data points
Get started with SEND today
SEND – Are You Ready?
Or, contact Covance today!
│ An Introduction to SEND - Dec 2016 12
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)
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