slides: are you send ready? preparing for send implementation and its resulting benefits
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Copyright © 2015 Covance. All Rights Reserved
Public
SEND – STANDARD FOR EXCHANGE
OF NONCLINICAL DATA
Are You SEND Ready? Preparing for SEND Implementation
and It’s Resulting Benefits
Rachel Harper, HNC
OUR SPEAKER TODAY
► SEND Lead for Covance European Sites
► Extensive experience in validation and
software system life cycles
► 2 years experience of SEND Dataset
production
► Member of the SEND consortium DART and
Ocular sub-teams
► 20+ years at Covance
Webinar - Are You SEND Ready? - April 2015 2
Covance Is Delivering SEND To Clients Today!
19 clients
281 studies
773 deliveries
73,100,793,450 data points
Webinar - Are You SEND Ready? - April 2015 3
Do You Feel You Are SEND Ready?
A. Yes, we are already receiving SEND datasets
B. No, but actively in the process of getting ready
C. No, but we know we need to start soon
D. No, what is SEND? Hope to find that out today!
POLL QUESTION: PICK ONE
Webinar - Are You SEND Ready? - April 2015 4
A Surprising Finding. What Led To SEND?
CURRENT STATE Consult several different tables individually
Leaf through hundreds of pages of data
FORWARD LOOKING Use SEND dataset + a visualization tool
Data on one screen….easily organized to see trends
Webinar - Are You SEND Ready? - April 2015 5
What Is SEND?
• SEND is an implementation of the Study Data Tabulation
Model (SDTM) for nonclinical toxicology studies
• Allows a standardized, electronic presentation of
individual toxicology study data points which defines how
to format non clinical data and enables the development
and use of software tools to increase effectiveness and
efficiency of data review
• Developed by CDISC SEND Team for formatting of data
collected from animal toxicology studies
SEND: THE CDISC STANDARD FOR EXCHANGE OF NONCLINICAL DATA
Webinar - Are You SEND Ready? - April 2015 6
Who Is The CDISC?
CLINICAL DATA INTERCHANGE STANDARDS CONSORTIUM
Webinar - Are You SEND Ready? - April 2015
CDISC IS:
a global, open, multidisciplinary, non-profit organization that has established standards
to support the acquisition, exchange, submission and archive of clinical research data and
metadata.
MISSION:
develop and support global, platform-independent data standards that enable information
system interoperability to improve medical research and related healthcare areas.
CDISC STANDARDS:
are vendor-neutral, platform-independent and freely available via CDISC website.
http://www.cdisc.org/CDISC-Vision-and-Mission
7
S
A Consortium Is Established
Composition of the Consortium
► Core Team
► Multiple Subteams
► Leadership Team
Involvement of FDA representatives
► IT input
► FDA reviewers
Covance has been a member since 2002
OBJECTIVE: DEVELOP THE STANDARD
Webinar - Are You SEND Ready? - April 2015
Covance is active in SEND Consortium and FDA/PhUSE
(Pharmaceutical Users Software Exchange)
Core
Team
Ocular
DART
Safety
Pharm
Genetic
Tox
CT
Leadership
8
SEND Vision – To Standardize Data Reporting
Webinar - Are You SEND Ready? - April 2015
What
SEND =
Standard for
Exchange of
Nonclinical
Data
Current guide:
SENDIG 3.0
Pharma
CROs
Software
solution vendors
Why • Controlled
terminology
• Standardized
format
• Regulatory
reviewer use
(eliminates data
entry by agency)
• Operational use
(data warehouse/
visualization)
Who
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10
SEND Guideline Will Be Progressively Modeled
Today
SENDIG 3.0
• General Toxicology
− GLP
− Non-GLP
− Single Dose
− Multiple Dose
• Carcinogenicity
Tomorrow
SENDIG 3.1
• Safety Pharm
– Cardiovascular
– Respiratory
SENDIG Nonclinical
Developmental and
Reproductive
Toxicology 1.0
• DART
− EFD
Study Data
Reviewer’s Guide
Beyond
• Ocular
• Genetic Toxicology
• Safety Pharm
– CNS
• Dataset XML format
• DART
− FEE
− PPND
Webinar - Are You SEND Ready? - April 2015 10
Priority Has Been Set for Standardization
• Priority set for new
studies for NDA
submissions
(Dec 2016)
• IND studies coming
in next wave
(Dec 2017)
• …Pharmacology will
come, but later
NOT EVERYTHING WILL BE REQUIRED DAY 1
Webinar - Are You SEND Ready? - April 2015
Source: DEC 2013 http://www.phusewiki.org/wiki/index.php?title=Prioritization_of_Nonclinical_Data
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What Is The Timeline Requirement?
2015 2016 2017 2018 2020 2021
Final Guidance
Issued
New NDA and BLA
studies must comply
Original IND
studies must comply
24 months
36 months
Ticks marks represent years
Webinar - Are You SEND Ready? - April 2015
Defined as protocol
finalization
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What Do YOU Need To Be SEND-Ready?
► Ability to accept/handle large files
► Software to view and use your SEND dataset
► Storage solution for warehousing large files
► Ability to submit SEND datasets to FDA
BASIC REQUIREMENTS FOR YOU TO ACCEPT SEND
Webinar - Are You SEND Ready? - April 2015
ACCEPT
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Which One Of These Is YOUR Biggest Concern?
A. Ability to accept/handle large files
B. Software to view and use your SEND dataset
C. Storage solution for warehousing large files
D. Ability to submit SEND datasets to FDA
POLL QUESTION: PICK ONE
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How SEND Arrives
► Data types presented in separate “domains” (i.e.: Body Weight (BW) data in BW domain)
► Multiple domains make one dataset for one study
► The domains are in .xpt format (readable by SAS Viewer)
► Each dataset has a “define” file explaining certain details
IT’S A COPY OF THE DATA PRESENTED IN THE FINAL STUDY REPORT
Webinar - Are You SEND Ready? - April 2015 15
Data Domains Modeled In SENDIG v3.0
• Dosing data (EX)
• Clinical Obs (CL)
– Clinical Exam
– Post Dose Obs
– Ophthalmic Obs (text)
– Dermal Obs (text)
• Body Weight (BW)
– Inlife Body Weight
– Terminal Body Weight
• Body Weight Gain (BG)
• Food/Water
Consumption (FW)
• ECG (EG)
• Vital Signs (VS)
– Blood Pressure
– Body Temp
– Heart Rate
• Clinical Pathology (LB)
– Hematology
– Coagulation
– Clinical Chemistry
– Urinalysis/UChem
– Immunophenotyping
• Animal Fate (DS)
• Death Diagnosis (DD)
• Palpable Masses (PM)
• Pharmacokinetic
Concentrations (PC)
• Pharmacokinetic
Parameters (PP)
– Cmax, Tmax etc
• Organ Weight (OM)
– Absolute Organ Weight
– Organ/Brain Weight ratio
– Organ/Body Weight ratio
• Macroscopic Obs (MA)
• Microscopic Obs (MI)
• Tumor Findings (TF)
16 Webinar - Are You SEND Ready? - April 2015
Some domains may change in subsequent updates
(e.g., vital signs will be updated in SENDIG v3.1)
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New Players Need To Collaborate With SEND
Webinar - Are You SEND Ready? - April 2015
Regulatory
Procurement
IT
Study Teams
Understand submission requirements
Vendor selection
Software validation & implementation
Nonclinical data production, scientists,
subject matter experts (SME)
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SEND Software Vendors
Webinar - Are You SEND Ready? - April 2015
► FOUR vendors with SEND software solutions
► Actively participating in the CDISC SEND consortium
18
Ask Your CRO About Their SEND Readiness
Webinar - Are You SEND Ready? - April 2015
Compliance
- What is validation status for 21 CFR Part 11
compliance of SEND system?
- Do you validate SEND 3.0 datasets before
delivering to sponsors?
Content
- Which SEND version(s) supported?
- Which domains are included?
(e.g., "stock" vs manual)
Data transfer logistics
- Stipulations for max file size?
- What data formats beyond XPT? (e.g., Excel, CSV)
- What are the file transfer methods?
(e.g., sFTP or other secure file exchange)
- Dataset availability? What triggers their creation?
(e.g., X days after data archival; with draft report.)
Process
- Do you have SEND capabilities?
- # SEND datasets in last year?
- What portion of your capabilities are
automated and/or validated?
- Can I get a sample study data package
(including sample define file) to review?
- Can you provide interim SEND datasets?
Cost
- What are standard costs for producing
SEND datasets for current studies?
- What is cost for producing multiple datasets
for one study? (e.g.: interim/draft & final)
PHUSE recommended questions: http://www.phusewiki.org/wiki/index.php?title=SEND_I
mplementation_Wiki_-
_SEND_between_Organizations
MAKE SURE YOU KNOW
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SEND – It’s Not Only An FDA Requirement,
You Can Benefit In Many Ways…
Data Warehousing
Data Visualization
Statistical Analysis
Historical Control Data
IDENTIFY
TRENDS & ANOMALIES
Sta
nd
ard
iz
atio
n
Webinar - Are You SEND Ready? - April 2015 20
Thank You – Questions?
Webinar - Are You SEND Ready? - April 2015 21
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