Brett Villagrand Senior Director, Product Solutions

Brett Villagrand Senior Director, Product Solutions
Industry Clinical R&D Platforms Offer Compelling Options to Drive Performance Brett Villagrand Senior Director, Product Solutions 25 Sept 2014 This is a Title Slide with Picture slide ideal for including a picture with a brief title, subtitle and presenter information. To customize this slide with your own picture: Right-click the slide area and choose Format Background from the pop-up menu. From the Fill menu, click Picture and texture fill. Under Insert from: click File. Locate your new picture and click Insert. To copy the Customized Background from Another Presentation on PC Click New Slide from the Home tab's Slides group and select Reuse Slides. Click Browse in the Reuse Slides panel and select Browse Files. Double-click the PowerPoint presentation that contains the background you wish to copy. Check Keep Source Formatting and click the slide that contains the background you want. Click the left-hand slide preview to which you wish to apply the new master layout. Apply New Layout (Important): Right-click any selected slide, point to Layout, and click the slide containing the desired layout from the layout gallery. Delete any unwanted slides or duplicates. To copy the Customized Background from Another Presentation on Mac Click New Slide from the Home tab's Slides group and select Insert Slides from Other Presentation… Navigate to the PowerPoint presentation file that contains the background you wish to copy. Double-click or press Insert. This prompts the Slide Finder dialogue box. Make sure Keep design of original slides is unchecked and click the slide(s) that contains the background you want. Hold Shift key to select multiple slides. Apply New Layout (Important): Click Layout from the Home tab's Slides group, and click the slide containing the desired layout from the layout gallery.

This is a Safe Harbor Front slide, one of two Safe Harbor Statement slides included in this template. One of the Safe Harbor slides must be used if your presentation covers material affected by Oracle’s Revenue Recognition Policy To learn more about this policy, For internal communication, Safe Harbor Statements are not required. However, there is an applicable disclaimer (Exhibit E) that should be used, found in the Oracle Revenue Recognition Policy for Future Product Communications. Copy and paste this link into a web browser, to find out more information. For all external communications such as press release, roadmaps, PowerPoint presentations, Safe Harbor Statements are required. You can refer to the link mentioned above to find out additional information/disclaimers required depending on your audience. Oracle Confidential – Internal/Restricted/Highly Restricted

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

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 trials Single-therapy trials eClinical solutions save time and money by adding efficiencies, Five key areas of interest for CROs in the eClinical field are reviewed in more detail below. 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 Adaptive clin trials- new Oracle Confidential – Internal/Restricted/Highly Restricted

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 A study from the Tufts Center for the Study of Drug Development published in October 2012 indicates that contract support and technical service providers are expected to play a greatly increased role in drug development in the future. By gaining access to data in real time, those running clinical trials are given a much better insight into how the trials are running. It means that any problems that might occur can be pinpointed – and fi xed – much more quickly, allowing for tactical decisions about trials to be made while they are on-going. This is particularly important in light of the increase in adaptive trial designs (please refer to page 14 for further details). Research networks are increasingly being moved to R&D cloud platforms. The data effi ciencies they aff ord are signifi cant, as long as people’s concerns about confi dential and proprietary information being stored in an externalised network can be allayed. Perhaps the biggest advantage is the ability to transfer data from one site or platform to another. Other positive benefi ts include economies of scale, security and redundancy of data, with up-front capital expenditure rarely required, and CROs and sponsors alike paying for the space they need. There are potential challenges in terms of connecting all the diff erent pieces of technology, and this will require data management systems to be carefully implemented. This is an area that is starting to have a real impact in the clinical Oracle Confidential – Internal/Restricted/Highly Restricted

Examples of Oracle Life Sciences Innovations
MOBILITY INFORM, CRA & ANALYTICS KEY PRODUCT & THIRD PARTY INTEGRATIONS CLINICAL MONITORING CLOUD RISK BASED MONITORING DATA MANAGEMENT WORKBENCH REAL-WORLD SAFETY SURVEILLANCE & COMPARATIVE EFFECTIVENESS Suggest you pick a few of these to talk about. Note that you’ll go into Proteus in more detail on the next slide. Key Product & Third Party Integrations: Recent and pending InForm integrations include the following: Siebel Clinical Trial Management System (CTMS) Argus Health Sciences Data Management Workbench and Life Sciences Data Hub Third party integrations: Greenphire (to reduce time and cost compared with internal or outsource payment systems) Proteus Digital Health Clinical Monitoring Cloud: ** Press release issued** Combines the power of our market leading CTMS system with: Clinical Development Analytics Mobile CRA (for streamlined site visits via mobility) Integrated w InForm Enabled implementation of any monitoring strategies including centralized, targeted or risk based accordance with FDA, EMA, and TransCelerate Biopharma Guidance Real-World Safety Surveillance and Comparative Effectiveness: ** Press release introducing Empirica Healthcare** Enables health sciences organizations, regulatory agencies and healthcare payers and providers to develop safety surveillance, advanced risk management strategies and comparative effectiveness initiatives that improve product safety and healthcare outcomes VOICE-ENABLED (NUANCE) New advances MEDICATION ADHERENCE (PROTEUS)

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

Oracle Health Sciences Network (HSN)
Protocol Validator and Patient Recruiter Protocols Studies Healthcare Providers Life Sciences Participants De-identified Self Service Near Real Time Data De-identified Data Self-Service Alerts Results Goal to support 100M lives worldwide on the network 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 Recruitment According to a study published in early 2013 by the Tufts Center for the Study of Drug Development (CSDD), based on 150 clinical studies involving nearly 16,000 sites, 11% of sites in a given trial fail to enrol a single patient (IMS data puts this fi gure at 27%), 37% under-enrol, 39% meet their enrolment targets and only 13% exceed their targets. Retention Poor retention has a negative impact on the overall evaluable data for regulatory submissions, as it may threaten the overall validity of the results, particularly when dropout rates exceed 20% per treatment arm. In some cases, dropout rates can be as high as 40%, which can be a reason for trial abortion Network Participants Include:

Data Capture This is a Section Header with Picture slide ideal for including a picture with a brief title and optional subtitle. This slide can also be used as a Q and A slide. To customize this slide with your own picture: Right-click the slide area and choose Format Background from the pop-up menu. From the Fill menu, click Picture and texture fill. Under Insert from: click File. Locate your new picture and click Insert. To copy the Customized Background from Another Presentation on PC Click New Slide from the Home tab's Slides group and select Reuse Slides. Click Browse in the Reuse Slides panel and select Browse Files. Double-click the PowerPoint presentation that contains the background you wish to copy. Check Keep Source Formatting and click the slide that contains the background you want. Click the left-hand slide preview to which you wish to apply the new master layout. Apply New Layout (Important): Right-click any selected slide, point to Layout, and click the slide containing the desired layout from the layout gallery. Delete any unwanted slides or duplicates. To copy the Customized Background from Another Presentation on Mac Click New Slide from the Home tab's Slides group and select Insert Slides from Other Presentation… Navigate to the PowerPoint presentation file that contains the background you wish to copy. Double-click or press Insert. This prompts the Slide Finder dialogue box. Make sure Keep design of original slides is unchecked and click the slide(s) that contains the background you want. Hold Shift key to select multiple slides. Apply New Layout (Important): Click Layout from the Home tab's Slides group, and click the slide containing the desired layout from the layout gallery. Oracle Confidential – Internal/Restricted/Highly Restricted

Oracle Health Sciences InForm Suite
Purpose-Built Solution for Today’s Complex Trial Environment Data Warehousing*—Clinical Data Integration, Validation, and Cleansing Oracle Health Sciences Data Management Workbench Lab Management Oracle Health Sciences Lab Normals Management Tool On Demand Study Design and Library Management Central 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 IRT Solutions Safety Data and Reporting * Oracle Argus Safety Analytics * Oracle Health Sciences Clinical Development Analytics Trial Management Oracle Health Sciences Clinical Trial Management System InForm Data 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 Oracle Confidential – Internal/Restricted/Highly Restricted

Clinical Monitoring Cloud
This is a Section Header with Picture slide ideal for including a picture with a brief title and optional subtitle. This slide can also be used as a Q and A slide. To customize this slide with your own picture: Right-click the slide area and choose Format Background from the pop-up menu. From the Fill menu, click Picture and texture fill. Under Insert from: click File. Locate your new picture and click Insert. To copy the Customized Background from Another Presentation on PC Click New Slide from the Home tab's Slides group and select Reuse Slides. Click Browse in the Reuse Slides panel and select Browse Files. Double-click the PowerPoint presentation that contains the background you wish to copy. Check Keep Source Formatting and click the slide that contains the background you want. Click the left-hand slide preview to which you wish to apply the new master layout. Apply New Layout (Important): Right-click any selected slide, point to Layout, and click the slide containing the desired layout from the layout gallery. Delete any unwanted slides or duplicates. To copy the Customized Background from Another Presentation on Mac Click New Slide from the Home tab's Slides group and select Insert Slides from Other Presentation… Navigate to the PowerPoint presentation file that contains the background you wish to copy. Double-click or press Insert. This prompts the Slide Finder dialogue box. Make sure Keep design of original slides is unchecked and click the slide(s) that contains the background you want. Hold Shift key to select multiple slides. Apply New Layout (Important): Click Layout from the Home tab's Slides group, and click the slide containing the desired layout from the layout gallery. Oracle Confidential – Internal/Restricted/Highly Restricted

Oracle Health Sciences CTMS Suite
Purpose-Built Solution for Today’s Complex Trial Environment Data Warehousing—Clinical Data Integration, Validation, and Cleansing Oracle 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 Payments Investigator Payments PIP Adaptive Monitoring Siebel CTMS Clinical Development Analytics Mobile CRA HSGBU Data Management Suites Safety Data and Reporting Oracle Health Sciences Clinical Development Analytics Data Management and Collection Oracle Health Sciences InForm GTM Suite Oracle Clinical / Remote Data Capture Clinical Trials Management System Proven Scalability Multilingual Support Business Intelligence Clinical Process Automation Complex Trial Support Open UI Interoperability and Integration Siebel Enterprise Application Integration Prebuilt 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 Oracle Confidential – Internal/Restricted/Highly Restricted

Oracle CTMS, CDA, Mobile CRA
Clinical Monitoring Cloud Oracle CTMS, CDA, Mobile CRA 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 Mobile CRA: Study awareness and streamlined site visits via mobility Clinical R&D Cloud Manage: Application Monitoring, DR, Lifecycle Oracle Confidential – Internal/Restricted/Highly Restricted

Use Case: How We Support Risk-Based Monitoring
Adaptive Monitoring Use Case: How We Support Risk-Based Monitoring Following FDA, EMA, TransCelerate Clinical Data Analytics Quality by Design (QbD): Risk-based trial planning and impact simulation Quality Mgt Indicators Compliance Indicators Performance indicators Predictive risk simulations Subject Safety Compliance & Performance Data Integrity 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 Performance Historical Investigator Performance AEs EDC OC/RDC & InForm Quality by Design (QbD) Source Data Verification (SDV) Source Data Review (SDR) CTMS Siebel Clinical/CDA/MCRA SDR: quality & compliance Offsite/central monitoring Investigator quality and qualitative performance Mobility Mobile CRA SDV SDR (protocol compliance, site processes, documentation quality) Risk and Quality controls Safety Argus/Empirica Risk Scores/Indicators Risk-based inspections Signal Detection Analysis GOAL: Enable Life Sciences customers to deploy Centralized and Risk-Based Monitoring Strategies

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

Oracle Mobile CRA Vision
Site Monitoring Visits 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 Mobile CRA EDC CDA CTMS Argus Open Alerts/SaaG Voice Briefcase 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

Platform Integrations

Expanding eClinical Integrations – Current and Planned
Segment Current Integrations Planned integrations Additional External partnered Integrations EDC/Data Management InForm & IRT InForm & Central Designer InForm & Central Coding OC/RDC & TMS InForm ODM exports to customer repositories InForm Discrepancy Interface from customer repositories and Central Coding InForm & Argus Safety InForm and Data Management Workbench InForm Custom event ODM open export Standards Gateway (across all products) InForm & TRC InForm and LabPas Utility InForm and AGMednet InForm and Nuance InForm and Execo InForm and Qumas InForm and GreenPhire InForm and Proteus InForm and EMR Clinical Data Warehousing Life Sciences Data Hub (LSH) & OC/RDC LSH & Oracle Business Intelligence Enterprise Edition LSH & InForm Operational Planning, Tracking and Management Siebel CTMS & Financials SAP, JD Edwards, Lawson Siebel CTMS & EDC OC/RDC, InForm Siebel Clinical & Mobile CRA Clinical Development Analytics & OC/RDC Clinical Development Analytics & Siebel CTMS Siebel CTMS Document / Content MGMT Documentum, SharePoint, LiveLink Clinical Development Analytics & InForm Clinical Development Analytics & Cleartrial Cleartrial & Siebel CTMS Cleartrial & InForm Cleartrial to Greenphire Mobile CRA to Nuance CTMS and GreenPhire Mobile CRA to Qumas CTMS and Qumas

Expanding Safety Integrations – Current and Planned
Segment Current Integrations Planned integrations Additional External partnered Integrations Safety & Reporting Argus Safety & InForm Argus Safety & Argus Insight Argus Safety & Argus Interchange Argus Safety & Argus Japan Argus Safety & Argus Affiliate Argus Safety & Dossier Argus Safety & Argus Unblinding Argus Safety & Webcenter Argus Mart Argus Safety & Third parties Empirica Topics & Empirica Signal Empirica Topics &VAERS Empirica Study & LSH Empirica Study & InForm Empirica Healthcare & Empirica Topics Argus J Safety & InForm Argus Safety & TMS

Cloud Data Warehousing Platform

Data Warehousing & Analytics
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

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

Powering Pfizer’s CRO Strategy
Data Warehousing & Analytics Powering Pfizer’s CRO Strategy Study Operational Reports Program/portfolio milestones Partnership 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 / FSP On-going Studies: OC / RDC / TMS Pfizer Aggregate Reporting Visualization Data Mining Trial Master File (TMF) Contextual Reference Data Module (RDM) Clinical Aggregation Layer BUSINESS TECHNOLOGY Information eXchange Hub (IXH)

Personal & Translational Operational Excellence
Life Sciences Big Data Opportunities Lower care cost and raise care quality Accountable Care Patient Engagement Personal & Translational Medicine Operational Excellence 1 2 3 4 Chronic Disease Mgt. Care Patterns Population Health Pay for Performance Telemedicine Patient Advocacy Capacity Management Staffing Optimization Protocol Optimization Process Efficiency Supply Standardization Cost Accounting Customer Satisfaction Disease Mgt. / Prevention Social Media Interactions Care / Process Improvements Marketing / Branding Personal Preferences Individualized Treatment Biometrics Data Management Apply Research New Clinical Protocols Accountable Care: Numerous challenges in operating efficiently under new ACO models will require aggregation & analysis of vast amounts of data from widely disparate source systems, increased in-home device monitoring, treatment protocol outcome analyses, etc. Any one of these would qualify as a “Big Data” challenge – even considered independently. Patient Engagement: Consumers are a wildcard! Care plan adherence rates for most chronic conditions hover around 50%, even when we know, we don’t necessarily do – like the young high schooler with diabetes who engages in too much drinking and eating the wrong foods. Or the young woman with high cholesterol – she doesn’t feel negative symptoms so she ignores it. As providers attempt to influence behavior via the advent of advances in social media and biosensors, data volumes and velocity are set to explode here,. Meaningful use stage 2 stipulations around electronic engagement, which takes effect in the near term, is also driving interest in this area. Example: High Blood Pressure: Often Recognized, Still Poorly Controlled – Scott Hensley blog, NPR.org, 9/2012 - High blood pressure is considered anything greater than 140/90 36M or >50% of Americans with HBP still don’t have it under control (46% do have it controlled) Also a population of those “at risk” HBP, also known as hypertension 4x risk of death from stroke HBP 3x risk of death from heart disease HBP can be controlled with behavioral/lifestyle changes! - take medicine prescribed lose weight stop smoking Measure and track blood pressure Higher incidence in Black populations Patient Engagement, Social Media oppty: Austin man dies from West Nile virus – statesman.com 9/5/2012 US Wide 1590 cases, 65 deaths. Texas wide 1000 cases, 40 deaths. # increased 58% in 2 weeks those at highest risk over 50 Use repellent, don’t go out at nite – lifestyle changes Could Social Media scanning have spotted this outbreak & spread faster?? Operational Excellence: The ability to granularly (and consistently) analyze relationships between treatment plans, patient demographics, physician groups, care giver staffing, procedures, implants, etc. – can yield significant improvements across many of the listed dimensions. The problem today is that most organizations cannot consistently monitor these relationships on a daily basis – on ALL of their normal operating data. Personalized Medicine: The “n of 1” is borrowed from pharma parlance, an n of 1 clinical trial is one where a single patient is the entire trial, a single case study. Here we mean n of 1 care – care specifically for individual, ie. 35 years old, female, history of diabetes in family, hispanic background, susceptible to environmental allergies as live in Austin, the allergy capital of the world, which always progresses instantaneously into a chest infection needing to seen by a doc and treated with antibiotics, type A blood, don’t smoke but don’t exercise enough, borderline high cholesterol, see different doctors, embraces social media and technology, has a pacemaker and 2 heart surgeries, etc. Wouldn’t it be great if this person would get a text when allergy season is high, to take her medication of singulair which would prevent the allergic reaction in the first place? If you think about a large provider with 6M patients, then, we are talking about the n of 1 applied and customized 6M times… Translational Research: exciting new high stakes area for innovators, given the unprecedented confluence of: technology advances, dramatic drops in the cost of genomic sequencing, and molecular medicine advances. Applied research at the point of care vs. traditionally long lag times from research bench to clinical care promises to put the spotlight on the value of research, to make research matter

“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 These are examples of the many types of data we must integrate & analyze, and importantly – it is estimated that 80% of healthcare data still unstructured!

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

Outcome Analytics - Solution View
LSH Argus InForm TRC BIG DATA MANAGEMENT BIG DATA ANALYTICS BIG DATA APPLICATIONS BIG DATA INTEGRATION CREATE VALUE FROM DATA

“…being within 1% to 3% is well within our expectations.” Vertex
Clinical Research and Development Solutions Transforming 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% Optimize trials and reduce study timelines and costs by half -In plain English this slide comes down to helping you plan and initiate trials faster/better/cheaper -Thanks to Oracle Health Sciences ClearTrial with its built-in clinical intelligence and activity-based costing methodology, you can achieve the transformative optimization you see in the first four examples -As another example, Astellas has their entire book of work in ClearTrial, and are using the software not only to predict development costs but to also conduct accurate capacity forecasting for internal and outsourced trials across their portfolio – saving thousands of hours of wasted capacity overage at low-demand “valleys,” and reducing risk by ensuring that the organization and its CRO partners are sufficiently staffed to handle peak demand As mentioned before our integrated InForm-IRT solution is eliminating duplicate data entry to increase both efficiency and data accuracy And our intuitive study design tool allows even non-programmers to build complex studies in as little as three days, and simple trials in even less time 50% Streamline randomization & cut data entry time and effort Build trials in as little as 3 days 3

Clinical Research and Development Solutions Transforming 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 Automate collection and management of clinical biomarkers Know if and when someone took your drug -For trial conduct, the Oracle Clinical Monitoring Cloud gives you the flexibility to support monitoring strategies including risk-based monitoring – whether you follow FDA, EMA, TransCelerate, or your own best practices. -Anchored by comprehensive, real-time analytics that can pull data from any EDC system, the Clinical Monitoring Cloud integrates Oracle CTMS for advanced trial management capabilities, and our native mobile app Mobile CRA for mobile monitoring. -You can easily set up Risk Indicators and Thresholds for your Critical Processes and Critical Data, conduct early and ongoing risk assessment, and quickly adjust monitoring activities based on risks identified during the study -With our InForm data capture platform, our customers are reviewing and locking sites and trials in minutes rather than days or weeks, while providing higher-quality data to the biostats team to enable adaptive trials -we have also integrated the translational research capabilities mentioned earlier with InForm so you can leverage these capabilities to manage biomarker data for targeted therapies -Through our exclusive collaboration with Proteus Digital Health, we are the first in the industry to offer a medication adherence option integrated with an EDC system . This innovative solution leverages an organic chip on a pill to provide data automatically to Inform whether a patient took your drug - and when. -This insight to adherence within InForm helps you identify the optimum dose-response curve in Phase II studies to reduce Phase III failure rates, as well as identify any medication adherence issues early in Phase II or III. -We are also expanding our network of web services integrations of our solutions with leading eclinical providers such as Greenphire, Exco InTouch, and QUMAS. Through these integrations you can: -save up to 40% of your payment costs and increase site satisfaction by automating site payments from InForm -increase levels of patient-provided data through a device-independent ePRO solution linked to InForm -manage your electronic trial master file for submissions with InForm -finally, the best-in-class Argus safety suite and Empirica Study help you increase patient safety, manage study risk, quickly process and assess adverse events, and leverage a dynamic, visual data mining environment for detecting signals and emerging trends in adverse event data. You get an “early warning system” of problematic drug safety profiles so that you can take corrective action early in the trial – before spending millions of dollars on a trial and before delivering the drug to market - and most importantly of all, before patient lives are affected. Quickly add value with integrated partners Enhance patient safety and reduce trial risk

Clinical Research and Development Solutions Transforming 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 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 -for analysis and submission, our clinical warehousing solution enables the fast and accurate acquisition, cleaning, aggregation, and preparation of clinical trial data for regulatory submissions. -This solution also supports the collection of disparate data sources for a clinical trial, with automated discrepancy management and transformation into standards-ready data sets to reduce manual programming effort by up to 50%. -The Pfizer Clinical Aggregation Layer or CAL project was initiated three years ago to completely change the way Pfizer conducts R&D. Powered by Oracle’s life science warehouse and analytics platform, the initiative has exceeded its goals. At a recent conference the CAL project lead stated, “through our collaboration with Oracle Pfizer has succeeded in transforming our R&D core to deliver greater innovation.” -We can also help you maximize secondary use by integrating real-world data, such as EMR, disease registry and claims data, cross-platform omics data, your pre-clinical and clinical trial data, and data from publicly available sources. With this integrated view you can easily explore therapeutic efficacy and safety scenarios in cohorts or sub-populations to optimize study and program outcomes. -Our integration with Exco InTouch mentioned before can drive patient engagement through tailored content interfaces and by leveraging user experiences from daily interactions in the digital world to deliver health support -finally, Oracle Health Sciences Empirica Signal remains the gold standard in signal detection across all post-marketing channels Obtain a 3600 view of patient outcomes Quickly apply signal detection over all media channels

Brett Villagrand Senior Director, Product Solutions

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Brett Villagrand Senior Director, Product Solutions

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