12
1 Dawn Kaminski Senior Director, Data Strategies eClinical Solutions Software Demonstration: Transforming Clinical Data Chaos with elluminate ®
1
Dawn KaminskiSenior Director, Data StrategieseClinical Solutions
Software Demonstration:Transforming Clinical Data Chaos with elluminate®
2
One clinical data platform from ingestion to insights —across all data sources
Data Management
Data Sciences & Programming
Clinical Operations
Pharmacovigilance
Biostatistics
Executive Management
DATA CONSUMERS
INTELLIGENTAPPLICATIONS
DATA INGESTION, MAPPING & STORAGE
XLS
DATA SOURCES
FORMATS
Genomics
Claims
eSource
CSVXML
SAS
IVRS EHREDC
CTMSeCOA Labs
Excel
Analytics
Mapper
CTMS
Risk Based Quality Management
Data Central
Importer
Metadata & Standards
3
SOURCE DATA INGESTION STORAGE GOVERNANCE TRANSFORMATION INSIGHTS
AUTOMATION ENGINE
EDCCTMSeCOAIWR/IRTSafetyEMRReal World DataLabs
Clinical Systems
Data Formats
SAS
Importer
MDRCDISCCustom DictionariesTransfer Specs
Standards
EDCCTMSSafetyLabs......
Staging Areas
DomainsVariablesVersioningSearch/Compare
Metadata
Mapper
SDTM/ADaMConversion
Data Listings Exception Listings Data Reconciliation Custom Reports
Compute Environment
SDTMReporting Exception ListingsReconciliation Listings......
Data Marts
Notifications
OUTBOUND APISDATA EXTRACTION SAS INTEGRATIONelluminate integration via APIs | Standards Management & Governance | Study Builds and Rapid UATM
DR
Direct File Upload
Incremental Review Change Tracking Issue Management Patient Profiles Query Management
Data Central
Clinical Analytics Trial Operations Cross-Study Analytics
Analytics
KRIsAnalytics
Risk Based Monitoring
eDriveDirect Web
APIs
Data Validation
XLSX
XML CSV ZIP
Trial OperationsForecastingResource Planning
CTMS
4
SOURCE DATA INGESTION STORAGE GOVERNANCE TRANSFORMATION INSIGHTS
AUTOMATION ENGINE
EDCCTMSeCOAIWR/IRTSafetyEMRReal World DataLabs
Clinical Systems
Data Formats
SAS
Importer
MDRCDISCCustom DictionariesTransfer Specs
Standards
EDCCTMSSafetyLabs......
Staging Areas
DomainsVariablesVersioningSearch/Compare
Metadata
Mapper
SDTM/ADaMConversion
Data Listings Exception Listings Data Reconciliation Custom Reports
Compute Environment
SDTMReporting Exception ListingsReconciliation Listings......
Data Marts
Notifications
OUTBOUND APISDATA EXTRACTION SAS INTEGRATIONelluminate integration via APIs | Standards Management & Governance | Study Builds and Rapid UATM
DR
Direct File Upload
Incremental Review Change Tracking Issue Management Patient Profiles Query Management
Data Central
Clinical Analytics Trial Operations Cross-Study Analytics
Analytics
KRIsAnalytics
Risk Based Monitoring
eDriveDirect Web
APIs
Data Validation
XLSX
XML CSV ZIP
Trial OperationsForecastingResource Planning
CTMS
5
SOURCE DATA INGESTION STORAGE GOVERNANCE TRANSFORMATION INSIGHTS
AUTOMATION ENGINE
EDCCTMSeCOAIWR/IRTSafetyEMRReal World DataLabs
Clinical Systems
Data Formats
SAS
Importer
MDRCDISCCustom DictionariesTransfer Specs
Standards
EDCCTMSSafetyLabs......
Staging Areas
DomainsVariablesVersioningSearch/Compare
Metadata
Mapper
SDTM/ADaMConversion
Data Listings Exception Listings Data Reconciliation Custom Reports
Compute Environment
SDTMReporting Exception ListingsReconciliation Listings......
Data Marts
Notifications
OUTBOUND APISDATA EXTRACTION SAS INTEGRATIONelluminate integration via APIs | Standards Management & Governance | Study Builds and Rapid UATM
DR
Direct File Upload
Incremental Review Change Tracking Issue Management Patient Profiles Query Management
Data Central
Clinical Analytics Trial Operations Cross-Study Analytics
Analytics
KRIsAnalytics
Risk Based Monitoring
eDriveDirect Web
APIs
Data Validation
XLSX
XML CSV ZIP
Trial OperationsForecastingResource Planning
CTMS
6
SOURCE DATA INGESTION STORAGE GOVERNANCE TRANSFORMATION INSIGHTS
AUTOMATION ENGINE
EDCCTMSeCOAIWR/IRTSafetyEMRReal World DataLabs
Clinical Systems
Data Formats
SAS
Importer
MDRCDISCCustom DictionariesTransfer Specs
Standards
EDCCTMSSafetyLabs......
Staging Areas
DomainsVariablesVersioningSearch/Compare
Metadata
Mapper
SDTM/ADaMConversion
Data Listings Exception Listings Data Reconciliation Custom Reports
Compute Environment
SDTMReporting Exception ListingsReconciliation Listings......
Data Marts
Notifications
OUTBOUND APISDATA EXTRACTION SAS INTEGRATIONelluminate integration via APIs | Standards Management & Governance | Study Builds and Rapid UATM
DR
Direct File Upload
Incremental Review Change Tracking Issue Management Patient Profiles Query Management
Data Central
Clinical Analytics Trial Operations Cross-Study Analytics
Analytics
KRIsAnalytics
Risk Based Monitoring
eDriveDirect Web
APIs
Data Validation
XLSX
XML CSV ZIP
Trial OperationsForecastingResource Planning
CTMS
7
SOURCE DATA INGESTION STORAGE GOVERNANCE TRANSFORMATION INSIGHTS
AUTOMATION ENGINE
EDCCTMSeCOAIWR/IRTSafetyEMRReal World DataLabs
Clinical Systems
Data Formats
SAS
Importer
MDRCDISCCustom DictionariesTransfer Specs
Standards
EDCCTMSSafetyLabs......
Staging Areas
DomainsVariablesVersioningSearch/Compare
Metadata
Mapper
SDTM/ADaMConversion
Data Listings Exception Listings Data Reconciliation Custom Reports
Compute Environment
SDTMReporting Exception ListingsReconciliation Listings......
Data Marts
Notifications
OUTBOUND APISDATA EXTRACTION SAS INTEGRATIONelluminate integration via APIs | Standards Management & Governance | Study Builds and Rapid UATM
DR
Direct File Upload
Incremental Review Change Tracking Issue Management Patient Profiles Query Management
Data Central
Clinical Analytics Trial Operations Cross-Study Analytics
Analytics
KRIsAnalytics
Risk Based Monitoring
eDriveDirect Web
APIs
Data Validation
XLSX
XML CSV ZIP
Trial OperationsForecastingResource Planning
CTMS
8
SOURCE DATA INGESTION STORAGE GOVERNANCE TRANSFORMATION INSIGHTS
AUTOMATION ENGINE
EDCCTMSeCOAIWR/IRTSafetyEMRReal World DataLabs
Clinical Systems
Data Formats
SAS
Importer
MDRCDISCCustom DictionariesTransfer Specs
Standards
EDCCTMSSafetyLabs......
Staging Areas
DomainsVariablesVersioningSearch/Compare
Metadata
Mapper
SDTM/ADaMConversion
Data Listings Exception Listings Data Reconciliation Custom Reports
Compute Environment
SDTMReporting Exception ListingsReconciliation Listings......
Data Marts
Notifications
OUTBOUND APISDATA EXTRACTION SAS INTEGRATIONelluminate integration via APIs | Standards Management & Governance | Study Builds and Rapid UATM
DR
Direct File Upload
Incremental Review Change Tracking Issue Management Patient Profiles Query Management
Data Central
Clinical Analytics Trial Operations Cross-Study Analytics
Analytics
KRIsAnalytics
Risk Based Monitoring
eDriveDirect Web
APIs
Data Validation
XLSX
XML CSV ZIP
Trial OperationsForecastingResource Planning
CTMS
9
SOURCE DATA INGESTION STORAGE GOVERNANCE TRANSFORMATION INSIGHTS
AUTOMATION ENGINE
EDCCTMSeCOAIWR/IRTSafetyEMRReal World DataLabs
Clinical Systems
Data Formats
SAS
Importer
MDRCDISCCustom DictionariesTransfer Specs
Standards
EDCCTMSSafetyLabs......
Staging Areas
DomainsVariablesVersioningSearch/Compare
Metadata
Mapper
SDTM/ADaMConversion
Data Listings Exception Listings Data Reconciliation Custom Reports
Compute Environment
SDTMReporting Exception ListingsReconciliation Listings......
Data Marts
Notifications
OUTBOUND APISDATA EXTRACTION SAS INTEGRATIONelluminate integration via APIs | Standards Management & Governance | Study Builds and Rapid UATM
DR
Direct File Upload
Incremental Review Change Tracking Issue Management Patient Profiles Query Management
Data Central
Clinical Analytics Trial Operations Cross-Study Analytics
Analytics
KRIsAnalytics
Risk Based Monitoring
eDriveDirect Web
APIs
Data Validation
XLSX
XML CSV ZIP
Trial OperationsForecastingResource Planning
CTMS
10
SOURCE DATA INGESTION STORAGE GOVERNANCE TRANSFORMATION INSIGHTS
AUTOMATION ENGINE
EDCCTMSeCOAIWR/IRTSafetyEMRReal World DataLabs
Clinical Systems
Data Formats
SAS
Importer
MDRCDISCCustom DictionariesTransfer Specs
Standards
EDCCTMSSafetyLabs......
Staging Areas
DomainsVariablesVersioningSearch/Compare
Metadata
Mapper
SDTM/ADaMConversion
Data Listings Exception Listings Data Reconciliation Custom Reports
Compute Environment
SDTMReporting Exception ListingsReconciliation Listings......
Data Marts
Notifications
OUTBOUND APISDATA EXTRACTION SAS INTEGRATIONelluminate integration via APIs | Standards Management & Governance | Study Builds and Rapid UATM
DR
Direct File Upload
Incremental Review Change Tracking Issue Management Patient Profiles Query Management
Data Central
Clinical Analytics Trial Operations Cross-Study Analytics
Analytics
KRIsAnalytics
Risk Based Monitoring
eDriveDirect Web
APIs
Data Validation
XLSX
XML CSV ZIP
Trial OperationsForecastingResource Planning
CTMS
11
SOURCE DATA INGESTION STORAGE GOVERNANCE TRANSFORMATION INSIGHTS
AUTOMATION ENGINE
EDCCTMSeCOAIWR/IRTSafetyEMRReal World DataLabs
Clinical Systems
Data Formats
SAS
Importer
MDRCDISCCustom DictionariesTransfer Specs
Standards
EDCCTMSSafetyLabs......
Staging Areas
DomainsVariablesVersioningSearch/Compare
Metadata
Mapper
SDTM/ADaMConversion
Data Listings Exception Listings Data Reconciliation Custom Reports
Compute Environment
SDTMReporting Exception ListingsReconciliation Listings......
Data Marts
Notifications
OUTBOUND APISDATA EXTRACTION SAS INTEGRATIONelluminate integration via APIs | Standards Management & Governance | Study Builds and Rapid UATM
DR
Direct File Upload
Incremental Review Change Tracking Issue Management Patient Profiles Query Management
Data Central
Clinical Analytics Trial Operations Cross-Study Analytics
Analytics
KRIsAnalytics
Risk Based Monitoring
eDriveDirect Web
APIs
Data Validation
XLSX
XML CSV ZIP
Trial OperationsForecastingResource Planning
CTMS
12
elluminateDemonstration
