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

1. Industry Clinical R&D Platforms Offer Compelling Options to Drive Performance Brett Villagrand Senior Director, Product Solutions 25 Sept2014

2. Oracle Confidential – Internal/Restricted/Highly Restricted

3. Transforming Clinical R&D from Pipeline to Patient Oracle Confidential – Internal/Restricted/Highly Restricted

4. What’s Required: Transform Current Capabilities Cost benchmarking Activity-based planning 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 Siloed clinical workflow Integrated end-to-end workflow Holistic risk-based monitoring Targeted SDV End-to-end clinical data management EDC Trial evidence Genomics, biomarker and EMR data Static data Real-time, actionable data Laptops and PCs Smartphones and tablets Machine-to-machine data Manual data entry Multi-therapeutic trials Single-therapy trials Oracle Confidential – Internal/Restricted/Highly Restricted

5. What are CROs looking for in an eClinical Partner eClinical solutions save time and money by adding efficiencies • 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 improve recruitment and retention Oracle Confidential – Internal/Restricted/Highly Restricted

6. Examples of Oracle Life Sciences Innovations MOBILITYINFORM, CRA & ANALYTICS KEY PRODUCT &THIRD PARTY INTEGRATIONS CLINICAL MONITORING CLOUD RISK BASED MONITORING DATA MANAGEMENTWORKBENCH REAL-WORLD SAFETY SURVEILLANCE & COMPARATIVE EFFECTIVENESS VOICE-ENABLED (NUANCE) New advances MEDICATION ADHERENCE(PROTEUS)

7. Clinical R&D Platform: Pipeline to Patient Study Connect Identity Access Mgt LSW CLOUD Workflow, Clinical Data Model, MDM, MDR, CDR, Analysis CDA Trial Analyzer Risk-Based Monitoring Planning and Simulation CDA Cloud Clinical Performance Benchmarks IRT Trial Supply Mgt. Forecasting Planning GrantsForecast CRO Site Quality Metrics Third Party Data Sources Investigator Network/Portal LSW Cloud Trial Initiation InForm/OCRDC Monitoring Cloud Third Party Study Design Tools HSN Pt Recruit Protocol Validation Trial Initiation LSH / DMW / SCE • Protocol Collaboration • Study Design and Start-Up CTMS Data Capture & Data Mgt IRT (RTSM) Argus Site Reimbursement Payments Analytics OC RDC / TMS (Hosted) Trial Conduct CDA InForm Applications InForm Medical Adherence Insights Mobile CRA Medical Imaging End Point Adjudication Central Designer CRF Submit InForm Molecular Analytics eTMF eCTD Submission/Analysis ePRO / MHealth EHR (HSN) Post-Marketing InForm PMS CTMS Lite LSW Cloud OMICS Databank Patient Device M2M Networks Argus Empirica Signal Detection Legend Oracle Products Via Integrated Technology Partners Oracle Confidential – Internal/Restricted/Highly Restricted

8. Oracle Health Sciences Network (HSN) Protocol Validator and Patient Recruiter Self Service Near Real Time Data De-identified Data Protocols Protocols Studies Alerts Results Alerts Life Sciences Participants Healthcare Providers De-identified Self-Service Protocols Protocols Self-Service Self-Service Goal to support 100M lives worldwide on the network Provides network level results and provider level details in seconds Protects institutional IPand brings governance to collaboration Gives all patients access to the latest in research Sponsors share protocols with providers to tie patients to sites/physicians Participants retain full control over their data Network Participants Include:

9. Data Capture Oracle Confidential – Internal/Restricted/Highly Restricted

10. Oracle Health Sciences InForm Suite Trial Management Oracle Health Sciences Clinical Trial Management System Analytics *Oracle Health Sciences Clinical Development Analytics Purpose-Built Solution for Today’s Complex Trial Environment Safety Data and Reporting * Extracts and PDF Forms User and Site Provisioning Interoperability and Integration Study Design and Library Management Lab Management Data Analysis and Submission* Medical Coding and Dictionary Management Oracle Argus Safety Randomization and Drug Supply Management • Automatic Site Assessment • User Management System • e-Learning Oracle Health Sciences InForm Adapter Oracle Health Sciences WebSDM Solutions Oracle Health Sciences Lab Normals Management Tool On Demand Oracle Health Sciences Central Designer • SAS/ODM/SDTM • Oracle Health Sciences InForm CRF Submit Oracle Health Sciences Central Coding Oracle Health Sciences IRT Solutions InForm Data Capture and Query Management • Next-Generation User Interface • Multilingual Support • Reporting and Trial Management • Trial Portal • Data Viewer • Targeted SDV Data Warehousing*—Clinical Data Integration, Validation, and CleansingOracle Health Sciences Data Management Workbench *Oracle Advantage: Differentiated offerings for full end-to-end capabilities Oracle Confidential – Internal/Restricted/Highly Restricted

11. Clinical Monitoring Cloud Oracle Confidential – Internal/Restricted/Highly Restricted

12. Oracle Health Sciences CTMS Suite Safety Data and ReportingOracle Health Sciences Clinical Development Analytics Data Management and Collection Oracle Health Sciences InForm GTM SuiteOracle Clinical / Remote Data Capture Purpose-Built Solution for Today’s Complex Trial Environment Adaptive Monitoring Document Server Site Monitoring Visits * Interoperability and Integration Contacts Management and Collaboration Trial Management Trial Planning and Forecasting Analytics and Reporting * Siebel CTMS Clinical Development Analytics Mobile CRA HSGBU Data Management Suites Finance and Investigator Payments • Oracle Health Sciences Mobile CRA • Tablet-based Trip Reporting (Disconnected support) • Site Check-in for Compliance Siebel Enterprise Application Integration Prebuilt integrations to HSGBU Suite Oracle Health Sciences ClearTrial Siebel Clinical Trials Management System • MS-Office, Outlook Calendar integration • Mail Merge Siebel Base CRM for Clinical Trials Management Oracle Health Sciences Clinical Development Analytics Siebel CTMS Payments Investigator Payments PIP Siebel CTMS Clinical Trials Management System • Proven Scalability • Multilingual Support • Business Intelligence • Clinical Process Automation • Complex Trial Support • Open UI Data Warehousing—Clinical Data Integration, Validation, and CleansingOracle Health Sciences Data Management Workbench *Oracle Advantage: Differentiated offerings for full end-to-end capabilities Oracle Confidential – Internal/Restricted/Highly Restricted

13. Oracle CTMS, CDA, Mobile CRA Clinical Monitoring Cloud User Access Monitoring Cloud CTMS: Industry leading solution with new Open UI interface CDA: Analytical insights to support faster decision-making Support: Tier I and Tier II support via HSGBU and Product Support Clinical R&D Cloud Mobile CRA: Study awareness and streamlined site visits via mobility Manage: Application Monitoring, DR, Lifecycle Oracle Confidential – Internal/Restricted/Highly Restricted

14. Adaptive Monitoring Use Case: How We Support Risk-Based Monitoring • Quality by Design (QbD): Risk-based trial planning and impact simulation • Quality Mgt Indicators • Compliance Indicators • Performance indicators • Predictive risk simulations Clinical Data Analytics Following FDA, EMA, TransCelerate Visit Report Contents Historical Clinical Data EDC OC/RDC & InForm Site Visit Frequency • Quality by Design (QbD) • Source Data Verification (SDV) • Source Data Review (SDR) SDV Current Clinical Data TMF Compliance Data Entry & Approval • SDR: quality & compliance • Offsite/central monitoring • Investigator quality and qualitative performance Compliance & Performance CTMS Siebel Clinical/CDA/MCRA Data Integrity Data Cleanliness Subject Visits Out of Window Mobility Mobile CRA Follow Up Items • SDV • SDR (protocol compliance, site processes, documentation quality) Historical Site Performance Enrollment Rate Historical Investigator Performance Clinical Supplies Risk and Quality controls Safety Argus/Empirica Screen Failure Rate • Risk Scores/Indicators • Risk-based inspections • Signal Detection Analysis Protocol Deviations Subject Withdrawal Rate GOAL: Enable Life Sciences customers to deploy Centralized and Risk-Based Monitoring Strategies SAEs AEs Subject Safety

15. Oracle Clinical Development Analytics (CDA) Analytics and Reporting Enabling Operational Performance Management from Sites to Execs Executive Team Organizational Progress Head of Clinical Operations Departmental / Regional Progress CRA / Data Manager Study Progress Clinical Sites Site Progress 15

16. Site Monitoring Visits Oracle Mobile CRA Vision • Device Integrations • Notification & Offline support • GPS/Location capture for Trip Report • Native contacts listing and Calendar • EDC • View of Source Data available for visit • Summary of Source Data Verified in Trip Report • Clinical Development Analytics • Site Metrics • Alerts • Briefcase Support • View SOP’s • Annotation & Bookmarks • Site Compliance • CTMS • Trip Report • Contacts and Site information • Calendar • Voice Notes & Voice Translation • Speech to Text for Trip Report Notes • Open Alerts & SaaG • Integration with 3rd party External & Internal system • Safety • Serious Adverse Event review and verification

17. Cloud Data Warehousing Platform Oracle Confidential – Internal/Restricted/Highly Restricted

18. Oracle LifeScience Data Warehouse Suite Data Warehousing & Analytics Life Sciences Data Hub Data Management & Aggregation Data Management Workbench Data Cleansing & Transformation Statistical Control Environment* Statistical Analysis & Reporting * Planned

19. Oracle Data Management Workbench Data Warehousing & Analytics Oracle Life Sciences Warehouse Suite Data Provider Data Management Workbench Analysis InForm Data Query Consolidate Labs Clean Transform Query Resolution * Planned

20. Data Warehousing & Analytics Powering Pfizer’s CRO Strategy Parexel Systems Pfizer Run Studies ICON Systems Future Acquisitions/ Future Partners PXL / ICON / FSP On-going Studies: OC / RDC / TMS Pfizer Information eXchange Hub (IXH) Pfizer owned and operated systems Information eXchange Hub (IXH) Contextual Reference Data Module (RDM) Safety Operational Data Warehouse (ODW) Clinical Scientific Data Warehouse (CSDW) Trial Master File (TMF) Clinical Supply Aggregate Reporting Visualization Data Mining Study Operational Reports Program/portfolio milestones Partnership Scorecard Project Mgmt Others Clinical Aggregation Layer BUSINESS TECHNOLOGY

21. “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

22. Big Data Analytics Platform for Life Science Mobile Sensors and Remote Monitoring in Clinical Trials SIMPLIFY ACCESS INTEGRATE & MANAGE DISCOVER & PREDICT • INTERDISCIPLINARY DATA PLATFORM Oracle Healthcare Data Warehouse Foundation • Oracle COHORT • EXPLORER ORACLE DATA INTEGRATOR ORACLE BIG DATA CONNECTORS BIG DATA ETL ORACLE GOLDENGATE • ORACLE CLINCIAL • SAFETY ANALYTICS Oracle Health Sciences Omics Data Bank Moby CaBIG i2b2 PatientsLikeMe CLINICAL • ORACLE BUSINESS • INTELLIGENCE Oracle Life Science Data Hub PubMedCentral PUBChem BioCatalogue NCBI Blast TAVERNA • ORACLE ADVANCED ANALYTICS ORACLE EXADATA ORACLE SPATIAL & GRAPH SEMANTICS ORACLE NoSQL DATABASE FASTQ BAM BAM Argus InForm ORACLE ENDECA INFORMATION DISCOVERY Alignment and Assembly ORACLE BIG DATA APPLIANCE FastQ,BAM CDH TIME

23. Outcome Analytics - Solution View LSH Argus InForm TRC BIG DATAANALYTICS BIG DATAAPPLICATIONS CREATE VALUEFROM DATA BIG DATAMANAGEMENT BIG DATAINTEGRATION

24. Clinical Research and Development SolutionsTransforming Clinical R&D from Pipeline to Patient “…being within 1% to 3% is well within our expectations.” Vertex PLANNING AND INITIATION Create detailed cost, timeline, and FTE scenarios in minutes Achieve 99% accuracy in budgeting forecasts Shorten trial planning cycle times by up to 50% 50% Optimize trialsand reduce study timelines and costs by half Streamline randomization & cut data entry time and effort Build trialsin as little as 3 days 3

25. Clinical Research and Development SolutionsTransforming Clinical R&D from Pipeline to Patient “InForm helps shorten trial delivery times, reduces costs, and maximizes the number of patient trials we can carry out.” Cancer Research UK TRIAL CONDUCT Easily implement strategic risk- based monitoring Review, clean & transform data up to 60% faster Automatecollection and management of clinical biomarkers Enhance patient safety and reduce trial risk Know if and when someone took your drug Quickly add value with integrated partners

26. Clinical Research and Development SolutionsTransforming Clinical R&D from Pipeline to Patient “Pfizer is enabling better clinical trial execution and improving decision-making through predictive analytics.” Accenture ANALYSIS AND SUBMISSION Easily manage Big Data for regulatory submissions Reducemanual 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 optimizetrial design and develop new indications Obtain a 3600 view of patient outcomes Quicklyapply signal detection over all media channels