Copyright © 2015 Covance. All Rights Reserved

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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

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Covance Is Delivering SEND To Clients Today!

19 clients

281 studies

773 deliveries

73,100,793,450 data points

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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

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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

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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

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Who Is The CDISC?

CLINICAL DATA INTERCHANGE STANDARDS CONSORTIUM

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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

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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

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Covance is active in SEND Consortium and FDA/PhUSE

(Pharmaceutical Users Software Exchange)

Core

Team

Ocular

DART

Safety

Pharm

Genetic

Tox

CT

Leadership

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SEND Vision – To Standardize Data Reporting

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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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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

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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

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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

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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

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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

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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)

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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

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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

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► FOUR vendors with SEND software solutions

► Actively participating in the CDISC SEND consortium

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Ask Your CRO About Their SEND Readiness

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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

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Thank You – Questions?

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