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