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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