1. Executive Presentation to ABC Pharma
[name of presenter]
[title of presenter]
-excited to be here
-thanks for your time
-we’re excited about the future of the industry
Across the clinical research and development landscape, pharmaceutical (biotechnology, medical device companies) and CROs are evaluating operations to improve efficiencies and the efficacy of personalized medicine. This evaluation process involves satisfying the current and future needs of patients, payers, providers, and regulatory authorities while significantly improving health outcomes and lowering costs. The best approach to complete these objectives is through a fast, accurate, and real-world platform that shapes industry advancements rather than reacting to them.
-we’ll focus today on how we’re helping clinical R&D through transformative technologies that are working today to go beyond incremental improvements to help research and development thrive
-will also demonstrate why our customers see us as a strategic partner today, and the partner that can best help them prosper and grow into the future

2. The following is intended to outline our general product direction
The 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.
Safe harbor statement.

3. Oracle Health Sciences
Transforming clinical research and development from pipeline to patient as…
LEADER
INNOVATOR
COLLABORATOR
Oracle Health Sciences is transforming clinical research and development from pipeline to patient. We help improve patient outcomes by providing actionable insights from aggregated clinical and healthcare data while optimizing trial efficiency and productivity. We enable you to leverage industry-shaping and transformative R&D technologies that keep your operations at the forefront of the rapidly changing clinical landscape.
How we’re doing this – why we’re successful
Founded 2007
Dedicated division of thousands of software and domain experts
Global operations & 24/7 support
Dozens of new products and major releases in 2013 including our end-to-end clinical data management solution and the first-ever mobile app for site monitoring – more about both later
Products and expertise across clinical, safety, and healthcare
Backed by Global 500 software company
US $4.5B in R&D
US$37 billion in revenue
#1 in life sciences and 50 industry categories

4. Oracle Health Sciences
Oracle Health Sciences - Addressing Critical Industry Challenges
Oracle Health Sciences
#1 in life sciences per IDC
1st commercial scaling of global and complex EDC
LEADER
INNOVATOR
COLLABORATOR
#1 preferred EDC system among clinical sites
1st integration of genomics and biomarker data with EDC
Leader in Gartner Magic Quadrant for Data Warehousing
1st integration of biologic sensor data with EDC
…as a Leader
-We’re an industry leader by several measures and as determined by respected, independent sources
…as an Innovator
-We are innovating at a rapidly accelerating pace to bring transformative yet practical solutions to bear on R&D challenges. We were the first commercialize scalable EDC…first to automate and incorporate genomic and biomarker data into EDC trials, first to integrate sensor data captured from ingestible sensors into EDC trials as well as expand the introduction of Electronic Medical Records and other patient profile data into EDC trials.
…as a Collaborator
We continue to expand on our collaborations and partnerships with key industry organizations and thought leaders. We fund and participate in significant research with Tufts CSDD. We are long time and active participants in standards organizations such as CDISC and the ICH. We are also working closely with key organizations to establish new standards such as those for Risk Based Monitoring with TransCelerate.
Additionally, as a collaborator, Oracle as well as our solutions help regulatory agencies such as the FDA and the MHRA ensure the accuracy and safety of clinical trial data.
Finally, we continually collaborate with customers and partners in developing and advancing our clinical R&D solutions. Through our long time affiliations with various Oracle user groups through more involved Software Development Partner programs, customers such as Pfizer, Roche, Merck, Mayo Clinic, and MD Anderson Cancer Center and others help advance and grow the Oracle solutions.
#1 in pharmacovigilance and signal detection
Integration of EMR and healthcare data with EDC

5. How We Deliver Transformative Value for Clinical R&D
Optimize
Insight
Future-Proof
Real-World Focus
Deliver technology which helps you optimize across the clinical development life cycle
Provide deep and actionable insights from your aggregated clinical and healthcare data
Lead innovation and transformation by incorporating genomics, biomarker and real-world patient data
Offer a business and clinical platform that evolves and grows with you and the industry
We continually develop and incorporate innovations that can better optimize and fundamentally improve the current landscape of clinical R&D, such as activity based planning, the ability to take immediate action on real-time trial data, risk-based monitoring, adaptive trials, clinical data warehousing, the capture of biologic sensor data into clinical trials and more…
Our strengths in data management and analytics, planning and our ability to bring the data together and accessible to analysis tools continue to drive better insights and decisions for today’s clinical trials.
Going beyond optimization and Insights is where we transform the clinical R&D paradigm and innovate in major ways such as the integration and use of genomic and biomarker data and the use of healthcare data in clinical trials. These transformations enable you to conduct more effective trials and derive improved outcomes, research, real-world comparative effectiveness and safety monitoring.
Combined, our clinical R&D strengths provide an advance level of innovation and support that future-proofs your investment and ensures you of a business and clinical platform that grows with you (e.g., large investment in R&D; business stability; solutions aligned with constantly evolving regulatory guidance e.g. FDA and EMA around risk-based monitoring)

6. Our Customers Leaders and Innovators Across Global Markets
Large Global Companies
Midsize International Companies
Emerging Growth
Companies
-customize logos as needed to ensure the prospect’s peer group, alliance partners, and CROs are included
The Oracle team is actively involved with the industry and our customers (User Groups/SDP) and we’re listening and capturing key challenges directly from them (you).
Objective: Quickly establish that we work with large, medium, small Pharma as well as regulators, CROs and others to develop technology that solves customer challenges.
Large, medium and small sponsors
CROs & Systems Integrators
Regulators
…all around the world.
RTB: Site satisfaction survey
RTB: SDP Program helps ensure functionality you want is built.

7. Key R&D Challenges We Hear From Our Customers
Planning
& Initiation
Analysis & Submission
Trial Conduct
Post-Marketing
Predict spend accurately
Optimize for cost/ schedule/resources
Speed setup and deployment
Deliver cleaner data faster
Reduce Phase II-III attrition
Make rapid, informed go/no-go decisions
Leverage genomic and biomarker data
Conduct fast and in-depth data analysis
Comply with regional and global standards
Gather and analyze usable real-world data
Enhance patient safety
Conduct rapid and effective audit defense
-this is what we’re seeing – most technologies in the market today are offering only incremental process optimization without addressing the underlying constraints
Planning & Initiation
Leveraging historical trial data
Making accurate short- and long-term cost and resource projections
-for example:
Determining fair market value for outsourced studies
Decreasing initial and follow-on study setup time
Planning & Initiation: According to a PharmaVoice survey, a 20% cost variance from plan to actual on a study is not uncommon - hampering companies’ ability to make informed investment decisions and optimize funding of trials
Finding most efficient trial design
Trial Conduct
Improving patient safety
Reducing costly Phase III failures
Trial Conduct: Attrition rates in Phase II-III trials continue to be high, with efficacy and safety issues accounting for 87% of Phase II-III failures in , according to the journal Nature Reviews Drug Discovery
Decreasing protocol amendments
Shortening data capture and time to database lock
Increasing effectiveness of biostats analysis
Submission & Approval
Submission & Approval: Audits from regulatory agencies create a pressing need to respond quickly and accurately; however many clinical systems require skilled programmers to interpret requests and days or weeks to run queries and reports, with additional cycles required for refinements – in fact a typical ‘data build’ at one Top 10 pharma for an analysis project took on average 14 days of computer ‘waiting time’
Speeding up submissions
Improving quality of submissions
Responding quickly and effectively to audits
Post-Marketing
Post-Marketing: It remains difficult to capture accurate and timely real-world data and analyze both structured and unstructured data, restricting companies’ efforts to ensure critical patient safety as well as conduct comparative effectiveness research
Obtaining and analyzing usable real-world data
(others)

8. Intensifying the Challenges…
Volume
Petabytes of structured and unstructured data
Variety
AE/SAE, ConMed, genomic, proteomic, EMR…
Velocity
Ultimately the challenges faced by clinical R&D all boil down to collecting, managing, and analyzing data
Dealing with this data is complicated the “three V’s” of data management – the volume, variety, and velocity of data is increasing exponentially, outstripping the capacity of most organizations to effectively contain it, much less make effective use of it
Volume – Due to increasingly complex protocols, a single large phase III trial can be hundreds of gigabytes, adding up quickly to petabytes of data over several trials – for example one successful Phase III mega trial we ran had a database of 175 GB, 230M total transactions, over 30M clinical data points, and more than 600,000 distinct auto queries
Variety – genomic, proteomic, EMR, adverse event…complicated by being in silos, different formats, etc.
Velocity – massive amounts of data coming in at an accelerating pace, due to increased demand for data and additional data sources as mentioned previously
Demand for increasingly rapid data collection and delivery
The “Hard Questions” in Clinical R&D Are Fundamentally Information Challenges

9. Traditional Solutions Are Lagging Behind Shifts in the Industry
Planning
& Initiation
Analysis & Submission
Trial Conduct
Post-Marketing
Inability to mine siloed and historical trial data
High variance in cost forecasts
Inability to predict FTE demand by schedule
Lack of ability to validate protocol and study design
Lack of innovation leads to focus on incremental efficiency gains
Shallow functionality beyond EDC core
Lack of real-time visibility to data including dosage
Time-intensive efforts to collect and clean data
Lack of genomic and biomarker data
Difficulty validating against real world data
Inability to track and trace data for reanalysis
Data sets don’t support fast, effective risk/benefit decision-making
Inability to capture usable real-world data
Limited ability to analyze structured and unstructured data
No way to compare real-world evidence with other data sources
Limited capture of AEs in marketed products
We know what you’re faced with in traditional solutions. Many traditional solutions lack the foresight and functionality to meet the demands of today’s rapidly evolving eClinical R&D market such as:
-making accurate cost forecasts to optimize your clinical investment and report to management or the board
-making accurate resource forecasts to maximize utilization of internal and outsourced resources and ensure trials are staffed sufficiently to help avoid failures
-designing in better safety and efficiency to increase patient health, reduce costs, and reduce change orders instead of focusing on dealing with them after the fact
-making informed and timely go/no-go decisions about a trial, instead of focusing on speeding up a trial that shouldn’t have been run in the first place
-responding to submission or audit questions accurately within hours or days instead of weeks
-populating data management platforms automatically with real-word data that is then analyzable, vs manual entry and conversion
-using mobility and BYOD to capture real-world data in a way that is natural for people

10. 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
Targeted SDV
Holistic risk-based monitoring
EDC
End-to-end clinical data management
Trial evidence
Genomics, biomarker and EMR data
Static data
Real-time, actionable data
Laptops and PCs
Smartphones and tablets
Manual data entry
Machine-to-machine data
Current capabilities provide a degree of what’s needed to design, manage and execute clinical trials, but fundamentals such as cost benchmarking, targeted SDV, static EDC, predominantly manual data entry and single-therapy trails provide a degree of optimization, but fall short of meeting the trends dominating the current landscape.
What’s required are innovative solutions that will transform your current processes and enable you to adapt to new trends that lower costs, speed trials and most importantly increase your clinical pipeline with more targeted research. Transformative capabilities that:
move from cost benchmarking to more activity-based planning
leverage a holistic and standards base risked-based monitoring approach
Incorporate real-world and patient-centric data such as genomics, biomarkers, EMR and public patient profile data
Automate the dosage information via ingestible, machine-to-machine transmission of data
Leverage innovation in hardware such as mobile tablets and smartphones
provides the ability to conduct multi-therapeutic trials by appyling different indications to patient cohorts based on genomic or biomarker
With these transformative capabilities…(speak to the list of benefits)
Single-therapy trials
Multi-therapeutic trials

11. Oracle Health Sciences eClinical Platform Transforms Clinical R&D from Pipeline to Patient
Planning
& Initiation
Analysis & Submission
Post-Marketing
Trial Conduct
Argus
Pharmacovigilance
Study Connect
Study Program
Web Portal
InForm
EDC
Real-World Data
Capture
Argus
Pharmacovigilance
Third-Party Integration
ePRO
CDA
Visualization /
Reporting / Analysis
Clinical
Performance
Analytics
InForm
EDC Platform
Trial Design / Library Mgmt / Data Capture & Cleansing / Coding / Lab Mgmt
IRT
RTSM
ClearTrial
Plan / Source / Track
Oracle Siebel
Trial Management
LSW
Clinical Data
WarehouseAnalysis
& Reporting
Empirica
Signal
Detection
Safety
Suite
Monitoring &
Signal Detection
Data Management Workbench
Data
Transformation
& Management
Empirica
Healthcare
HSN
Protocol
Validation
& Patient
Recruitment
Standards
Gateway
CDISC
HSN
EMR Data
Translational
Research
Center
Genomics/Biomarkers
Translational
Research
Center
Genomics/
Biomarkers
EHA
Real-World
Healthcare
Data
Mobile CRA
Mobile Monitoring
Third-Party Integration
eCTD
Proteus
Adherence
We are developing an unmatched end-to-end platform across trial planning, trial conduct, analysis, submission, and post-marketing, leveraging the depth and breadth of our solutions including ClearTrial, Siebel CTMS, CDA, InForm, and LSW.
We are providing a robust and agile integration framework (web services and standards-based) so that our eco-system of carefully selected technology partners can easily integrate with our clinical platform and our customers have the choice and autonomy to integrate and optimize their processes
Leading to an enhanced eClinical ecosystem that will provide increased value for customers
Partner solutions:
Automated Site Payments: Greenphire
eTMF: QUMAS
Imaging & Adjudication: AG Mednet
Medication Adherence: Proteus
eCTD: QUMAS
ePRO: Exco InTouch
You’ve asked to see our capabilities for (pick up from discovery and “What’s Required: Transform Current Capabilities” slide and jump to relevant product/solutions slides/demo – e.g., accurate forecasting and budgeting, end-to-end clinical data management, holistic risk-based monitoring, accelerating trial cycle-times, reducing Phase II-III attrition, reducing trial costs, etc.)
Third-Party Integrations
Imaging & Adjudication
Automated Site Payments
eTMF
HSN
EMR
Data
HEALTH SCIENCES CLOUD