END-TO-END DATA AND METADATA: IT'S NOT ONLY A DREAM, IT'S A REALITY

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© Confidential | 00 mois 2013 | Nom de la présentation | Auteur 1

A VISION : ADOPT AN END-TO-END PROCESS FROM THE PROTOCOL TO THE CSR 01

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© Confidential | 00 mois 2012 | Nom de la présentation | Auteur 2

STATE OF THE ART

From Prehistoric ages to Clinical Standardised Digitalisation

Data Visualisation Needs

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Old Process • Paper CRF • Outsourcing • Low number of standards

New Process • Electronic CRF • 100% CDISC compliant Tools in an End-to-End process

• Ease Data Visualization and Exploitation

Digitalisation • Electronic PRO based on Smartphone application

• Medical Devices • Connected objects data capture

© October 09-12th, 2016 | End-to-End : It’s not just a dream, it’s a reality | Gérald NEVEU

Support for Data Review Meeting based on Clinical Data

Study Metadata exploitation

Monitor Clinical Operations (Enrollment Curve, SDV, Data Entry, Queries, …)

Data Management Metrics (Time to Data Entry, Number of queries per subject, Data change, …)

More it is big, more it is important

End-to-EndMetadata

Seman

-callyIn

terope

rableMetad

ataDriven

ProtocolConceptsandAssessments ADaMCDASH SDTM Endpoints&

AnalysisResultsDataCollec-on

Modules

STAN

DARD

S

LIBR

ARY

CLINICAL STUDY DATA LIFECYCLE

EDCSetup Genera-on AnalysisConversion

AUTO

MAT

ION

&VAL

IDAT

ION

CRF

Endpoints&AnalysisResults

CDASH ADaMSDTM

Protocol TrialDesign

STUDY

METAD

ATA

REPO

SITO

RY

© Business & Decision Life Sciences 2016 All rights reserved. Author : Peter Van Reusel

AnalysisResults

PLAN

NING&

REPO

RTING

DataManagement

Sta-s-calProgramming

ClinicalStudyReport

ClinicalDevelopment

Plan

Source SDTM ADaM TFLs

Submission

PROCE

SS&

DATA

Protocol

DataCollec-on

Sta-s-calAnalysisPlan

document

data

SAPAuthoring

Protocol&TrialDesignAuthoring

CSRAuthoring

AUTH

ORING

metad

ata

StudyDesignConfigura-on

StudySetup

AnalysisPlanning

SPEC

IFICAT

ION&

CONFIGURA

TION

ONCE UPON A TIME… A CLINICAL STUDY THROUGH DATA VISUALISATION 02

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© Confidential | 00 mois 2012 | Nom de la présentation | Auteur 5

DANONE CLINICAL DATA FLOW (DANFLOW)

ODMODMw/DATACRFMetadataRepository

Formedix ORIGINS®

Func

tion

Tool

s

Physical Exam

Adverse Events

Con Meds.

DataRepository

Medidata RAVE ® OpenClinica

SDTM

SAS.xpt

EDCETL

Define.xml

XML4Pharma SDTM ETL ® File Server

Task

CRF Design Data Collection and Processing Data Mapping Data Storage

ETL

EDC Independent Study doc.generation

Speed up Build

Ben

efits

Best ratio : Study Needs / Cost saving

Automate SDTM Mapping User friendly – Drag & Drop

Ease data pooling Data Visualization Data Warehousing

CDASH Standards

Adopt a compatible ePRO solution

SDTM Standards

© October 09-12th, 2016 | End-to-End : It’s not just a dream, it’s a reality | Gérald NEVEU

DATA Repository

Study Metadata

Operational Metadata

Metadata Catalog

Visualization

Study documents

DATA

DATA PREPARATION FOR VISUALISATION

Study documents capture

Clinical DATA Pooling Clinical Data

Warehouse

Trial Design Tables

SDTM Tables AdAM Tables

Assessments Interventions Findings

© October 09-12th, 2016 | End-to-End : It’s not just a dream, it’s a reality | Gérald NEVEU

DM METRICS AND CLINICAL DASHBOARDS (ONGOING)

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EDCETL

Visualization ODM

Web

Services

Ensure up-to-date data

© October 09-12th, 2016 | End-to-End : It’s not just a dream, it’s a reality | Gérald NEVEU

DATA VISUALISATION SOME EXAMPLES 03

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© Confidential | 00 mois 2012 | Nom de la présentation | Auteur 9

METADATA CATALOG VISUALISATION GLOBAL OVERVIEW

© October 09-12th, 2016 | End-to-End : It’s not just a dream, it’s a reality | Gérald NEVEU

METADATA CATALOG VISUALISATION STUDY ID CARD

© October 09-12th, 2016 | End-to-End : It’s not just a dream, it’s a reality | Gérald NEVEU

CLINICAL DATA VISUALISATION ENROLLMENT CURVE PER VISIT – DROP OUT

© October 09-12th, 2016 | End-to-End : It’s not just a dream, it’s a reality | Gérald NEVEU

CLINICAL DATA VISUALISATION SUBJECT RECRUITMENT PER WEEK

© October 09-12th, 2016 | End-to-End : It’s not just a dream, it’s a reality | Gérald NEVEU

RETURN-ON-EXPERIENCE 04 00 mois 0000

© Confidential | 00 mois 2012 | Nom de la présentation | Auteur 14

USE CASES & BENEFITS

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Metadata Catalog

Trial Design Tables

EDC

Clinical Data Warehouse

SDTM Tables AdAM Tables

Visualization Raw and Analysis data capitalisation Data Review meeting support Cross study Data Exploitation

Clinical study results

Scientists : Establish new Clinical development plan for future products Manager : Have an overview on KPI from all past studies Biostatistician : Help to build statistical plan for Meta-analysis

Clinical operations monitoring Data Management metrics

Risk Based Monitoring

…a clinical study

© October 09-12th, 2016 | End-to-End : It’s not just a dream, it’s a reality | Gérald NEVEU

RETURN-ON-EXPERIENCE

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Mandatory to use an End-to-End process integrally based on CDISC Standards for

Data, Metadata and Data Management tools.

Retrieve efficiently and easily all data & information from the protocol to the CSR ensuring a continuous workflow among Clinical Core team members

Importance to use a Agile methodology based on Use Cases/User Stories to create visualisation for each

business needs and exploit efficiently data & information for each user profile

© October 09-12th, 2016 | End-to-End : It’s not just a dream, it’s a reality | Gérald NEVEU