copyright © 2014 oracle and/or its affiliates. all rights reserved. | industry clinical r&d...

Copyright © 2014 Oracle and/or its affiliates. All rights reserved. |

Industry Clinical R&D Platforms Offer Compelling Options to Drive Performance

25 Sept 2014

Brett VillagrandSenior Director, Product Solutions


Safe Harbor StatementThe following is intended to outline our general product direction. It is intended for information purposes only, and may not be incorporated into any contract. It is not a commitment to deliver any material, code, or functionality, and should not be relied upon in making purchasing decisions. The development, release, and timing of any features or functionality described for Oracle’s products remains at the sole discretion of Oracle.

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Copyright © 2014 Oracle and/or its affiliates. All rights reserved. | Oracle Confidential – Internal/Restricted/Highly Restricted 3

Transforming Clinical R&D from Pipeline to Patient


What’s Required: Transform Current Capabilities

Siloed clinical workflow

Cost benchmarking

Targeted SDV

Smartphones and tablets

Activity-based planning

Holistic risk-based monitoring

Real-time, actionable data

EDC

Trial evidence

Static data

Increase drug and device pipeline

Reduce phase II-III attrition

Deliver personalized therapies

Mine trial data for off-target indications

Improve patient safety

Make precise cost and resource forecasts

Reduce trial timelines by months

Reduce trial cost by millions

Conduct fast, effective audit defense

Machine-to-machine data

Genomics, biomarker and EMR data

End-to-end clinical data management

Integrated end-to-end workflow

Laptops and PCs

Manual data entry

Multi-therapeutic trialsSingle-therapy trials


What are CROs looking for in an eClinical Partner

• Real-time data access allows for faster intervention• Cloud platforms enhance data efficiencies• Mobile devices simplify data collection in real time• Patient engagement solutions can help improverecruitment and retention


eClinical solutions save time and money by adding efficiencies


Examples of Oracle Life Sciences Innovations

MOBILITYINFORM, CRA & ANALYTICS

KEY PRODUCT & THIRD PARTY INTEGRATIONS

DATA MANAGEMENTWORKBENCH

VOICE-ENABLED (NUANCE)

New advancesMEDICATION ADHERENCE (PROTEUS)

CLINICAL MONITORING CLOUD

REAL-WORLD SAFETY SURVEILLANCE & COMPARATIVE EFFECTIVENESS

RISK BASED MONITORING


Clinical R&D Platform: Pipeline to Patient

Trial Conduct

Submission/Analysis

Post-Marketing

LSW

CLO

UD

Wor

kflow

, Clin

ical

Dat

a M

odel

, MD

M, M

DR,

CD

R, A

naly

sis

Protocol CollaborationStudy Design and Start-Up

Trial Initiation

InForm Applications

Data Capture & Data Mgt

InForm/OCRDCCTMS

Monitoring Cloud

Argus

InForm Medical Adherence Insights

eTMF

Medical ImagingEnd Point Adjudication

Site ReimbursementPayments Analytics

Planning

Trial Initiation

Central Designer

eCTD

Via Integrated Technology Partners

InForm PMSEHR (HSN)

OMICS Databank

CTMS Lite

ePRO / MHealth

InForm Molecular Analytics

CDA Trial AnalyzerRisk-Based Monitoring

Planning and Simulation

CDA CloudClinical Performance

Benchmarks

IRTTrial Supply Mgt.

ForecastingGrants

ForecastCRO Site Quality

Metrics

HSNPt Recruit

Protocol Validation

Third PartyStudy Design

Tools

OC RDC / TMS (Hosted)

IRT (RTSM)

LSH / DMW / SCELSW Cloud

CDA

Study Connect Identity Access Mgt

Empirica Signal Detection

CRF Submit

Patient Device M2M Networks Argus

Investigator Network/Portal

Mobile CRA

Third PartyData Sources

LSW Cloud

Oracle ProductsLegend


Oracle Health Sciences Network (HSN)Protocol Validator and Patient Recruiter

Network Participants Include:

Provides network level results and provider level details in seconds

Sponsors share protocols with providers to tie patients to sites/physicians

Participants retain full control over their data

Protects institutional IP and brings governance to collaboration

Gives all patients access to the latest in research

ProtocolsStud

ies

Healthcare Providers Life SciencesParticipants

De-identified

Self ServiceNear Real Time Data

De-identified Data Pro

tocols

ProtocolsSelf-Service

Self-Service Self-

Service

Ale

rts

Alerts Results

Goal to support 100M lives worldwide on the network

Protocols


Data Capture


Oracle Health Sciences InForm SuitePurpose-Built Solution for Today’s Complex Trial Environment

Data Warehousing*—Clinical Data Integration, Validation, and CleansingOracle Health Sciences Data Management Workbench

Lab Management

Oracle Health SciencesLab Normals Management Tool On Demand

Study Design and Library Management

Oracle Health SciencesCentral Designer

User and Site Provisioning

Automatic Site Assessment User Management System e-Learning

Medical Coding and Dictionary Management

Oracle Health Sciences Central Coding

Randomization and Drug Supply Management

Oracle Health Sciences IRTSolutions

Safety Data and Reporting *

Oracle Argus Safety

Analytics *Oracle Health Sciences Clinical Development Analytics

Trial Management Oracle Health Sciences Clinical Trial Management System

InFormData Capture and Query Management

Next-Generation User Interface Multilingual Support

Reporting and Trial Management Trial Portal Data Viewer Targeted SDV

Interoperability and Integration

Oracle Health Sciences InForm Adapter

Extracts and PDF Forms SAS/ODM/SDTM Oracle Health Sciences InForm

CRF Submit

Data Analysis and Submission*

Oracle Health Sciences WebSDM Solutions

*Oracle Advantage: Differentiated offerings for full end-to-end capabilities


Clinical Monitoring Cloud



Oracle Health Sciences CTMS SuitePurpose-Built Solution for Today’s Complex Trial Environment

Data Warehousing—Clinical Data Integration, Validation, and CleansingOracle Health Sciences Data Management Workbench

Trial Management

Siebel Clinical Trials Management System

Contacts Management and Collaboration

Siebel Base CRM for Clinical Trials Management

Site Monitoring Visits *

Oracle Health Sciences Mobile CRA Tablet-based Trip Reporting (Disconnected

support) Site Check-in for Compliance

Analytics and Reporting *

Oracle Health Sciences Clinical Development Analytics

Finance and Investigator Payments

Siebel CTMS PaymentsInvestigator Payments PIP

Adaptive Monitoring

Siebel CTMSClinical Development Analytics

Mobile CRAHSGBU Data Management Suites

Safety Data and ReportingOracle Health Sciences Clinical Development Analytics

Data Management and Collection Oracle Health Sciences InForm GTM Suite

Oracle Clinical / Remote Data Capture

Siebel CTMSClinical Trials Management System

Proven Scalability Multilingual Support Business Intelligence

Clinical Process Automation Complex Trial Support

Open UI

Interoperability and Integration

Siebel Enterprise Application IntegrationPrebuilt integrations to HSGBU Suite

Document Server MS-Office, Outlook Calendar

integration Mail Merge

Trial Planning and Forecasting

Oracle Health Sciences ClearTrial

*Oracle Advantage: Differentiated offerings for full end-to-end capabilities


User Access

Mobile CRA: Study awareness and streamlined site visits via mobility

CTMS: Industry leading solution with new Open UI interface

CDA: Analytical insights to support faster decision-making

Supp

ort:

Tie

r I a

nd T

ier I

I sup

port

vi

a H

SGBU

and

Pro

duct

Sup

port

Manage: Application Monitoring, DR, Lifecycle

Clinical R&D Cloud

Monitoring Cloud

Clinical Monitoring Cloud Oracle CTMS, CDA, Mobile CRA


Use Case: How We Support Risk-Based MonitoringFollowing FDA, EMA, TransCelerate

Subject Safety

Compliance & PerformanceDataIntegrity

Protocol Deviations

Data Entry & Approval

Data Cleanliness

Follow Up Items

Site Visit Frequency

Screen Failure Rate

Subject Withdrawal Rate

TMF Compliance

Clinical Supplies

SDV

Enrollment Rate

Subject Visits Out of Window

Visit Report Contents

Historical Clinical Data

SAEs

Current Clinical Data

Historical Site PerformanceHistorical Investigator

Performance

AEs

SafetyArgus/Empirica

EDCOC/RDC & InForm

CTMSSiebel

Clinical/CDA/MCRA

MobilityMobile CRA

• Quality by Design (QbD)• Source Data Verification (SDV)• Source Data Review (SDR)

• SDR: quality & compliance• Offsite/central monitoring• Investigator quality and

qualitative performance

• SDV• SDR (protocol compliance,

site processes, documentation quality)

Clinical Data Analytics

• Risk Scores/Indicators• Risk-based inspections• Signal Detection Analysis

• Quality by Design (QbD): Risk-based trial planning and impact simulation

• Quality Mgt Indicators• Compliance Indicators• Performance indicators• Predictive risk simulations

Risk and Quality controls

GOAL: Enable Life Sciences customers to deploy Centralized and Risk-Based Monitoring Strategies

Adaptive Monitoring


Enabling Operational Performance Management from Sites to Execs

15

ORACLE CLINICAL DEVELOPMENT ANALYTICS

Executive Team

Head of ClinicalOperations

CRA / Data Manager

Clinical Sites

Organizational Progress

Departmental /RegionalProgress

Study Progress

Site Progress

Analytics and Reporting Oracle Clinical Development Analytics (CDA)


Oracle Mobile CRA Vision

Mobile CRA

EDC

CDA

CTMS

ArgusOpen Alerts/SaaG

Voice

Briefcase

EDC

• View of Source Data available for visit

• Summary of Source Data Verified in Trip Report

CTMS

• Trip Report

• Contacts and Site information

• Calendar

Safety

• Serious Adverse Event review and verification

Clinical Development Analytics

• Site Metrics

• Alerts

Device Integrations

• Notification & Offline support

• GPS/Location capture for Trip Report

• Native contacts listing and Calendar

Open Alerts & SaaG

• Integration with 3rd party External & Internal system

Voice Notes & Voice Translation

• Speech to Text for Trip Report Notes

Briefcase Support

• View SOP’s

• Annotation & Bookmarks

• Site Compliance

Site Monitoring Visits


Cloud Data Warehousing Platform



Data Aggregation

Operational Control

Data Cleaning

Safety Monitoring

Analysis and Reporting

Submission Prep

Data Standards

CROs

ClinicalProgramming

Partners

StatisticalProgramming

ClinicalOps

DataManagement

Investigators

BioStats

Patients

LabVendors

Safety

Regulatory

MedicalMonitoring LSW

Life Sciences Data HubData Management & Aggregation

Data Management WorkbenchData Cleansing & Transformation

Statistical Control Environment*

Statistical Analysis & Reporting

* Planned

Data Warehousing & Analytics Oracle LifeScience Data Warehouse Suite


* Planned

Oracle Life Sciences Warehouse Suite

Consolidate

Clean

Transform

Labs

InForm

Data Query

Query Resolution

Data Provider Data Management Workbench Analysis

Data Warehousing & Analytics Oracle Data Management Workbench


Powering Pfizer’s CRO Strategy

Study Operational ReportsProgram/portfolio milestonesPartnership Scorecard

Clinical Scientific Data Warehouse

(CSDW)

Operational Data Warehouse

(ODW)

Parexel Systems Pfizer Run Studies ICON Systems

Future Acquisitions/

Future Partners

Pfizer owned and operated systems

Safety

Clinical Supply

Project Mgmt

Others

Information eXchange Hub

(IXH)

PXL / ICON / FSPOn-going Studies: OC /

RDC / TMS

Pfizer

Aggregate ReportingVisualizationData Mining

Trial Master File (TMF)

Contextual Reference Data Module (RDM)

Clinical Aggregation LayerBUSINESS TECHNOLOGY

Information eXchange Hub (IXH)

Data Warehousing & Analytics


“Big Data” Encompasses Many Types of Data With Varying Volume, Speed, and Structural challenges

Structured and Unstructured Data• EMR Records, free-text notes, images

Internal & External Sources• Research, pharmacy, govt, population, other providers

Medical Device / Machine-Generated• Blood pressure, Heart rate, glucose levels, weight, etc

Clinical• Lab test results, pharma, pathology reports, discharge

summaries, clinician notes,etc.

Imaging & Diagnostics

Web, Call Center, Social Media

Financial & Operational• Procedures, costs, charges, payments

“Omics”• Genomics, Proteomics, Metabolomics

History, Family, Demographic


Big Data Analytics Platform for Life Science Mobile Sensors and Remote Monitoring in Clinical Trials

SIMPLIFY ACCESSINTEGRATE & MANAGE DISCOVER & PREDICT

PubMedCentralPUBChemBioCatalogueNCBI BlastTAVERNA

Moby CaBIGi2b2PatientsLikeMe CLINICAL

INTERDISCIPLINARY DATA PLATFORM

ORACLE ADVANCED

ANALYTICS

ORACLE DATA INTEGRATOR

ORACLE BIG DATA

CONNECTORS

BIG DATA ETL

ORACLE GOLDENGATE

Oracle Healthcare Data Warehouse Foundation

Oracle Health Sciences Omics Data Bank

ORACLE EXADATA

Oracle Life Science Data Hub

ORACLE BIG DATA APPLIANCE

ORACLE ENDECA INFORMATION

DISCOVERY

ORACLE NoSQL

DATABASE

ORACLE SPATIAL &GRAPH SEMANTICS

ORACLE BUSINESS

INTELLIGENCE

Oracle COHORT

EXPLORER

CDH

ORACLE CLINCIAL

SAFETY ANALYTICS

Alignment and Assembly

FASTQBAMBAM

TIME

FastQ,BAM

Argus

InForm


Outcome Analytics - Solution View

Argus

InForm

TRC

LSH

BIG DATAMANAGEMENT

BIG DATAANALYTICS

BIG DATAAPPLICATIONS

BIG DATAINTEGRATION

CREATE VALUEFROM DATA

Copyright © 2013, Oracle and/or its affiliates. All rights reserved.28 Confidential – Oracle Internal

28

Clinical Research and Development Solutions

Transforming Clinical R&D from Pipeline to Patient

Create detailed cost, timeline,and FTE scenarios

in minutes

Achieve 99% accuracyin budgeting forecasts

Shorten trial planning cycle times by up to 50%

Streamline randomization & cut data entry time and effort

Build trials in as little as 3 days

PLANNING AND INITIATION

Optimize trials and reduce study timelines and costs by half

50%

3

“…being within 1% to 3% is well within our

expectations.” Vertex


29


Transforming Clinical R&D from Pipeline to Patient TRIAL CONDUCT

Review, clean & transform data up to 60% faster

Automate collection and management ofclinical biomarkers

Easily implement strategic risk-based monitoring

Quickly add value with integrated partners

Know if and when someone took your drug

Enhance patient safety and reduce trial risk

“InForm helps shorten trial delivery times, reduces costs, and maximizes the number of patient trials we can carry out.”

Cancer Research UK


30


Transforming Clinical R&D from Pipeline to Patient ANALYSIS AND SUBMISSION

Easily manage Big Data for regulatory submissions

Reduce manual data entry and labor oversight by 30-50%

Compress time-to-value by 50% with pre-built analytic apps

POST-MARKETING

Maximize secondary use to optimize trial design and develop new indications

Obtain a 3600 view of patient outcomes

Quickly apply signal detection over all media channels

“Pfizer is enabling better clinical trial execution and improving decision-making

through predictive analytics.” Accenture

https://www.dropbox.com/s/7h9jytslj8adrjj/10683_001_Accenture_life_sciences_cloud_v4.mp4

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