© 2020 Cognizant

Digital data flow - A solution for Study Start up and Amendments

AGENDAITEMS

Cognizant’s Setup Accelerator solution3

2 Our POV on Digital Data Flow Acceleration in Clinical Trials

1

Demonstration4

TranCelerate’s Digital Data Flow vision

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TransCelerate’s view on “Current vs Future” Digital Data Flow

SoA

Technical Solution

Common Data Model

• Design Elements

• New Processes

• Agnostic Technical Solutions

PROTOCOL

EDC

SAP

CSR

CSRSAPEDCSoAProtocol

Cur

rent

Futu

re

Areas where Digital interventions can accelerate clinical trials & improve experience

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Study Startup Study Conduct Study Close

Sponsor Teams

Investigators

Patients

Accelerate Study design & Optimization

Accelerate EDC, IRT, eCOAsetup

Accelerate Site Activation Faster Data reviews – CDM & Medical

Safety Notifications Burden management

Reduce site burden on initiation & accelerate Activation

Find patients faster and Accelerate patient recruitmentDigitally connect investigators with patients

Self manage their performance better

Better operations management

Better search experienceBetter informed consent experience

Better trial data collection experience

Faster statistical outputs

Faster CSR authoring

Digital Site closure

Better post trial experience

Functional Architecture

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IRT Integration Specification

Creation

IRT

Draft

ePRO Specification

Creation

ePRO

CDR Transformation

Draft

External Data transfer

Specification creation

TPV Data

Metadata Management

CDR

TPV Data Edit Check &

Reconciliation

SDTM/Adam Transformation

SAP

EDC & Clinical Data Management

IRT ePRO TPV Data CDR SDTM/ADaM

DIAGNOSTIC METADATA

eCRF & Edit CheckCREATION EXPANDED

eCRF & Edit CheckCREATION

EDC

MD

RAu

tom

ated

Stud

y Se

tup

Impa

ct

Anal

ysis

IRT Integration Specification Creation

Protocol Creation System

Protocol & Study Design

Protocol to CSR Data Automation Platform

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Protocol Creation system

Setup Accelerator

External data Other Operational Sources

Clinical Data Warehouse

Bio-stats accelerator

Clinical Data Standards managementMetadata based Study data management setup & amendment, data entry screen, edit-checks propagation

Data transformation SDTM creationLibrary driven SDTM, ADaM and TLF & Gs, Define.xml 2.0

Study managementData Management

Collaborative data review tool | Remote review

Configurable RACT | Critical Variables | Configurable Thresholds | Integrated Risk Management

Library driven data checks | manual Queries| External & safety data reconciliation | Send queries to EDC | Deviations Management & visualization

Statistical computing

environment

StudyDesigner

DataManager

Investi-gator

RTSM

TSDV Coder

IRT

WearablesSensors

eCOA

TSDVSafety

Gateway

eConsent

Coder

Imaging

Payment

PV System

E2B

EDC

OperationalAnalytics

Risk Based Study

Execution

PatientAnalytics

DataManagement

Console

Create Digital protocol content leveraging past protocols metadata and standard content from corporate templates including Transcelerate CPT

Protocol Author CSR

Cognizant Solutions

Clinical Systems

Patient

Setup Accelerator

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Metadata Management

Study Build

Impact Assessment

Protocol Elements

eCRF & edit checks

Integration with EDCs

Data acquisition & processing

Statistical analysis standards

Traceability

Governance Workflows

SETUP

ACCELERATOR

Protocol & Study Design

EDC & Clinical Data Management

IRT

ePRO

TPV Data

CDR

Statistical Analysis

Plan

Clinical Data Processing

Setup Accelerator – Summary of Features

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Metadata Governance Automated Study Setup Automated Impact Analysis Key Reports

Protocol Standards

Data Collection Standards

Ø EDC StandardsØ CRF StandardsØ Edit Check StandardsØ Custom Function Standards

Ø Third Party Vendor StandardsØ IRT StandardsØ ePRO Standards

Clinical Data Processing Standards

Ø Pre-processing Mapping data modelØ SDTM+

Statistical Computing Standards

Ø SDTM mapping Ø ADaM mapping

EDC Study Setup

Third Party Vendor Specification

IRT Setup/Specification

ePRO Setup/Specification

Clinical Data Processing Setup

Statistical Computing Setup

Collect Information

Impact Analysis Detail

Help in Decision Making

Post Production Template

Stakeholders Review

eApproval

Traceability Version Control

Object Traceability Report

Audit Trail Reports

System Performance Reports

User Activity Reports

EDC Setup

Mapping/Transformation Report

Study Reports

Impact Analysis Report

Ø Pre-processing Mapping data modelØ SDTM+

Ø SDTM mapping Ø ADaM mapping

Ø MDR Version Change Ø Protocol Amendment

Ø Study Stage/ Data processing CRF, Edit checks, CF

Ø Mapping, Pre-processing, SDTMØ Site InteractionsØ TSDV Signature

Ø Upfront Decision to implement

Ø Study Quality ReportØ Version Control ReportØ Auto/Manual Testing Report

Ø All SpecificationsØ Annotated CRFØ SDTM annotated CRFØ Define.XML

Ø MDR Version ChangeØ Protocol Amendment ReportsØ PPC & Impact AnalysisØ Stakeholder Approval Reports

Ø Global/TA/Study Specific TemplateØ Sections ManagementØ Fields ManagementØ Codelist Management

SYNCHRONIZATION TRACEABILITY & WORLFLOW COMPLETE AUDIT TRAIL

Takeaway

Differentiators

• Flexible in integrating data sources• Role Based Security Permissions• Streamlined review and approval

workflow • Aligned with Transcelerate’s Study

Design Document

Leveraging AI/ML

• AI/ML based recommendations for study design and other specifications

Vision

• Encourages automated Clinical reuse, Transform document Content to Data

• Automating configuration and enabling flow of information

• Moving electronic source to Sponsor DB and connect standards across Healthcare and Clinical Research

Demonstration

Home Page

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Protocol Standards

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Protocol Library Section view

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Study Protocol Elements

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Clinical Data Processing Standards view

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SDTM Standards view

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eDC Study Build view

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eDC CRF design view

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eDC design specification download view

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Impact Assessment view

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Impact Analysis Details view

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Thank You