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The Future of RTSM: Where Are We Today, and Where Are We Headed?October 26, 2016

James StreeterGlobal Vice President Life Sciences StrategyOracle Health Sciences Business Unit


Safe Harbor Statement

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.

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Todays Key Industry Challenges/Trends

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Cloud & Technology

• Clinical Applications to the Cloud

• Platform Approach to eClinical

• Integrated eClinical Systems

• Cloud CTMS - Lower Cost Through Standardized Configurations

• Cloud/True SaaS eClinical

• ePRO Usage and Integration

Data and Analytics

• eSource/Real World Data Collection

• EMR data integration with EDC

• Real World Evidence to support payer’s value

• Predictive and Operational Analytics

• Master Data Management/Registries (MDM/MDR)

• Unstructured Data Warehousing and Analysis (Big Data)

• mHealth - Collecting Wearable Device Data

• Simplifying Dictionary Services

Regulatory

• Data Transparency

• EU Directive re. Safe Harbor

• Implementing FedRamp/FISMA Compliancy

Business Process

• Moving to Investigator Payments Systems

• Linking Imaging to EDC

• Risk Based Monitoring

• Implementing TransCelerate –SIP and RBM

• Remote monitoring/eMonitoring

• Automating End to End Data Flow

• Moving Data Management back in-house at Pharma


Data Repository - Store/Control/Transform/Clean/AnalyzeCapture and AcquireDesignPlanning

Study Definitions

Meta Data Registry / Master Data Mgt

Source/Target Models, Transformation/Mappings....Events, Forms, Items,

Edit Checks, Codelist….Standards

(Sponsor/SDTM/ODM/PRM…)

Automating Clinical Data Flow

Trial Management & Monitoring

CTMS

Analytics

Data Collection & Management

RTSM

Coding

EDC

Safety Data & Signal Detection

Saftey

Signal Detection

Central Designer

CDASH 2.0 Forms Library

Custom Library Mgt

StandardsDesign

Review & Approval

Data Warehousing

Analytics & Business Intelligence

R & SAS

Reporting, Analytics, TLF

ReviewRaw SDTM ADaM

DataMgt

Tools

Clinical and Operations Data

Metadata, Configurations

Review & Approval

Standards Metadata

Review & Approval

Queries


Real World Data for Life SciencesManaging Unstructured and Structured Data

Genetics/

Omics DatamHealth/IOT

EHR

Images, Labs

OHF

Social Media

Health Sciences Applications

• Data Management Workbench (DMW)

• Life Sciences Hub (LSH)

• Oracle Healthcare Foundation (OHF)

• Clinical Development Analytics

• Cohort Explorer

• Empirica Signal

• Empirica Healthcare

• Empirica Study

Oracle Big Data Applications• Big Data Discovery & Hadoop

• Big Data Appliance

• Big Data SQL

• Advanced Analytics ‘R’ for Hadoop

Structured & Unstructured Data Sources

Identify & Develop New Therapeutic Interventions

mHealth/IOT

Device

Clinical TrialSafety

CTMSData

Warehouse

IRT/EDC


Discovery Lab Dis

cove

ry

Ou

tpu

t

Analytic Applications & Tools

Comprehensive Real World Data Analytics Platform for Life Sciences

RWD Data Technology for Unstructured Data Sources to your current Structured Data Analysis Environment

Data Factory

Big Data Discovery

RR

Clinical TrialSubmission

Clinical Data Warehousing and

Tools

EMR/EHR ‘Omics

Health Care Warehousing and

Tools

Data Lake

Analytic Applications

Analytic Tools

VisualizationTools

Un

stru

ctu

red

Dat

aSt

ruct

ure

d D

ata

Event Processor

eSource UnStructured EMRClinician Notes

Specialty DataBiomarkersStructured

Specialty DataBiomarkersUnstructured

Devices/WearablesSemistructured

Genomic & ProteomicStructured Data

Operational Data

TraditionalLab Data

EDC & IRTInvestigatorSites

Devices/ WearablesSemi-structuredVisible to Site

eSource Structured EMR

Genomic & ProteomicUnstructured Data

Imaging Data

Social Media

ePRO


Persistent Goals in Clinical Development

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Minimal Validation

Rapid Study Startup• Instant cloud provisioning

• Immediate access to study designerShrink Operational

Business Costs

Mitigate risk, cost and time of

upgrades and validation

Seamless IntegrationsSimplify and streamline integrations

Adapting to ChangeAdapting to changing regulations,

standards, technologies,

user roles

Streamline Uptake of ReleasesFaster adoption of new releases

Modern UX

Enabling Digital Data Flows

Modern user experience and

visualizations

Streamline data flows from growing

number of sources (EMR, devices, etc.)

• Ramp down reliance on internal systems

• Decrease overhead on IT resource expenditures


Cost, complexity and time constraints are driving the need for modern RTSM solutions

Speed Accelerating execution

trials increasingly important to increase product lifetime value

ControlSponsors want higher

degree of control over trial execution quality and operational metrics

:

Traditional RTSM solutions have serious limitations

CostSponsors

continuously look for ways to reduce

trial cost

Rely on services• Costly for sponsor• Source of delays• Source of risk for service

provider

Complex set up• Setup requires heavy

customization • Re-inventing the wheel for each

trial

Lack of Interopability• No seemless process & info flow• Lost opportunity to optimize

processes

ComplexityProtocols more complex, new « direct to patient »

trials requiring sophisticated supply logistics


RTSM

Data interopability as key part of an eClinical platform

Subject data eCOA

CTMS

Activity-Based Planning

Site Data

Supplies Data

EDC

Mobile AppsReconciliation

Forecasting

Operational Reporting / Analytics / Data Warehouse


Customers Require Modern Self-service RTSM

• Industry moving from traditional service model and to Self Service Model (CRO’s and Sponsors)

• CRO and Sponsors with internal built RTSM no longer want to maintain or redevelop their legacy systems

• Desire for configurable systems over custom programmed

• Need for simplified User Interface, mobile enabled

• Hardened security and data privacy rules

• Recently released self-service solutions are achieving success by addressing this key customer need


The Future of RTSM

• Advanced Predictive Analytics and Integrations with Study Build tools

– Manage supply and cost real time

– Big Data integration for inputs

– Expanded drivers for Safety Analytics

• Drug supply forecasting across all protocols for a program and compound

• Auto Configuration from the Protocol and Site Contracts

• Drug supply may ship to pharmacies, direct to patient

– Continued expansion of integrations

– Complexity levels will increase

• Master Data Management and Registry interoperability

• RTSM as a service and not as its own system

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The Future of RTSM con’t

• Patient Views and Interfaces– Mobile interfaces and patient adherence

– Bi-directional EMR integrations for data updates

– Supply Management will be a integral part as patient devices increase

• Key part of Post Marketing Studies– Unified drug management from Phase 1 to 4

• Manufacturing and labeling become core modules

• Regulatory and Inspector interfaces

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Key Takeaways

• Industry is changing – RTSM and EDC become functions of a marge larger data collection and operations

• Industry pressures on RTSM will continue to grow, – Increased efficiency from RTSM systems

– Interoperability that is seamless

– Less Customization

• RTSM will need to become a “proactive” vs. a reactive system

• Next-gen RTSM systems will need to integrate seamlessly into eClinical platforms from planning and initiation to post-marketing

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Key Takeaways

• Power of Oracle for Your Clinical Trials

• Oracle’s Technology Investment in R&D for Life Science

• HSGBU leveraging of Core Oracle Products and Cloud

• Convergence of Healthcare and Life Sciences Products

• Digital Trial with mHealth/IoT Connector

• Clinical One - Reinventing Clinical Trials – eClinical 2.0

• Oracle will be here for the next 40 years

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