Consolidating Clinical Trial Management, Mobility, and Monitoring in the Cloud James Streeter Senior...

Consolidating Clinical Trial Management, Mobility, and Monitoring in the Cloud

James StreeterSenior Director Life Sciences Product StrategyHSGBUOctober 1, 2014

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

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

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. | 4

Strategy

Life Sciences

Healthcare

Convergence

• Accelerate clinical development• Support entire drug safety lifecycle• Enable clinical data aggregation

• Power enterprise healthcare analytics • Enable provider/payer integration• Drive personalized medicine

• Intersection of clinical trials and clinical care• Develop collaboration networks for providers

and life sciences companies

Copyright © 2014, Oracle and/or its affiliates. All rights reserved. | 5

Oracle delivers advanced transformative value for clinical R&D in a modular, integrated and scalable cloud environment and helps you:

Clinical Research and Development Solutions

Delivering End-to-End Value

Optimize OperationsWith technology that helps you maximizeefficiency across your clinical life cycle

InnovateBy incorporating genomics, biomarkersand real-world patient data

Future-Proof your BusinessWith a platform that evolves and grows with you and the industry

Gain Actionable InsightsFrom aggregated clinicaland healthcare data

Copyright © 2014, Oracle and/or its affiliates. All rights reserved.6

Clinical R&D Platform : Pipeline to Patient

Trial Conduct

Submission/Analysis

Post-Marketing

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Plan Track SourceClearTrial

Study Start-Up and DesignProtocol Collaboration

Trial Initiation

InForm / Central Designer

Data Capture & Data Mgt

InFormCTMS

Monitoring Cloud

Argus

InForm Medical Adherence Insights

eTMF

Medical ImagingEnd Point

Adjudication

Site ReimbursementPayments Analytics

Planning

Trial Initiation

InForm Utilities

eCTD Gateway Standards Gateway

InForm Late PhaseEHR (HSN)

OMICS Databank

CTMS Cloud/ Call Centre

eCOA / 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

CRF Submit

Patient Device M2M Networks

Argus

Optimized and integrated processes across the clinical development landscape

Investigator Network/Portal

Mobile CRA

Third PartyData Sources

LSW Cloud

Via Integrated Technology Partners


Oracle Delivers the Most Advanced and Easy-to-Use Closed-loop Clinical Trial Management Offering

Plan • Oracle ClearTrial• Builds study plans based on actual study activities• Forecasts and budget resources, costs, units and timelines

Source • Oracle ClearTrial• Optimizes allocation of resources using simulations • Consolidates projects on portfolio level• Helps negotiate and manage RFPs and contracts

Execute • Oracle CTMS, Oracle IRT• Designs, codes and randomizes trials• Manages clinical trial execution

CaptureData

• Oracle Inform and OC/RDC• Captures clinical trial data electronically • Aggregates and maintains clinical trial data centrally • Analyzes clinical trial operations and outcome data

Track • Oracle ClearTrial• Tracks project status and accruals• Assesses strategy and automatically re-forecasts

Pay • Oracle Financials, Oracle PeopleSoft Financials• Makes payments from financial systems

Improve

Analyze

Source

Execute

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Pay


Oracle Health Sciences Clinical Monitoring Suite Purpose-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 Argus Safety & Empirica Tools

Data Management and Collection Oracle Health Sciences InForm GTM Suite

Oracle Clinical / Remote Data Capture

Siebel CTMS

Clinical 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


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Clinical Monitoring Cloud OfferingUser

Access SSO IDM

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

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Manage: Application Monitoring, DR, Lifecycle

Clinical R&D Cloud

Monitoring Cloud


CTMS


What’s New: Oracle Clinical Operations Cloud Service

Unlock the Full Value of Your Investment

Accelerated Implementations Better Compliance at Lower Cost Lower TCO and Infrastructure Costs Improved Processes and Controls Proactive Patches and Updates Reduce IT Management Time and Effort

MORE VALUE. MORE CHOICE. MORE CONFIDENCE.

Reduced Upgrade Risk and Downtime Far Fewer Average Service Requests World-Class Security and Compliance Ready-To-Go Environments for faster time to value Accelerators to leverage industry best practices Anywhere, Anytime Availability via Web 24x7 Support

Clinical R&D Cloud


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We always leverage our vast CTMS collateralLeverage our industry library of CTMS requirements and processes

Maintain a library of out of the box and pre-configured CTMS functionality to guide workshops

Utilize a Virtual Prototyping Environment to accelerate requirements and design sessions

Access to our library of CTMS implementation artifacts

A large library of pre-built Siebel CTMS processes


Pre-built CTMS Process Flows and Accelerator Configurations

Based on Leading Practices for: Document Management

Trip Reporting

Investigator Candidate Identification and Assessments

Study Setup

Protocol Authoring and Approval

Informed Consent, Investigator Brochure and Subject Materials Preparation

CRF Design

Subject Visit Template Setup

Select and Initiate Partners for Study

Site Selection

Monitoring/Site Evaluation

Randomization Request and Fulfillment

Site Initiation Package

Screening and Enrollment Tracking

Screening and Enrollment – IVRS

Monitoring – Site Initiation

Monitoring - Interim Monitoring

Monitoring – Closeout

Clinical Supplies Planning

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CTMS Accelerators leverage industry best practices to speed time to value

Each Package includes:• Pre-configuration Install File• High Level Design Specification• Functional Requirement • Design Approach• Step-by-Step Installation and System Testing instructions


Modernize with Siebel Open UI / Siebel Mobile

Enhanced User Experience: Maximize productivity

Any Browser: Flexible deployment

Templates: Create your own user experiences quickly

Any Device: Choose your platform with automatic device rendering

Coexist: Leverage existing Siebel investments

Advanced Standards: Tailor readily with common tech skills

Simplified Integration: Reduce total cost of ownership


Industries: plan, perform, and track field sales and service activities

Web Self-Service: empower customer self help

Themes: style for familiarity or brand

Open UI Customization Possibilities

Customer Dashboard: View top information on a single screen


Mobile: Native look and feel

• “Designed for Mobile”

• Device driven rendering; Infinite scrolling

• Integration with native Phone, PIM, location based integration

• Multi-touch gesturing (mobile) and HTML5

• Offline mode with synchronization (TBD)


Use Case: How We Support Risk-Based Monitoring

Following 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


Transcelerate & CDA Risk Category MappingsIndicator

Analytical & Reporting Marts Clinical Transactional ApplicationsCategory

Clinical Development Analytics (CDA) Argus Analytics CTMS

EDC Inform & OC/RDC Empirica

Argus Safety IRT

Safety X X X X X X

Investigational Product X X X X

Subject Recruitment and Discontinuation X X X

Management X X X

General Issues X X X

Data Quality X X X

CRF Completion X X X

Discrepancy Management X X X

On-site Workload-Based Triggers X X X

Essential Documents X X

Staffing, Facilities, and Supplies X X


Source Data& Systems Siebel CTMS

Suite Integration & Open Interfaces

External 3rd Party Data, Programs

InForm

Argus

OC/RDCEDC

Safety Trials Management

Life Sciences Data HubWarehouse

Analytics, Insight, & Content Mgmt Empirica Study Empirica TopicsRisk Analysis

Argus AnalyticsClinical Development Analytics

Access, Planning, &Collaboration Customer PortalMobile CRA

Clinical Dashboards & Reports

Clinical Warehouse & Data Marts

Signal and Risk Management

Analytics

ClearTrialMobile Planning

Risk-Based Monitoring Oracle’s Multi-System Holistic Approach


Siebel CTMSSuite Integration &

Open Interfaces

External 3rd Party Data, Programs

InForm

Argus

OC/RDC

Life Sciences Data Hub

Empirica Study Empirica TopicsRisk Analysis

Argus AnalyticsClinical Development Analytics

Customer PortalMobile CRA

Clinical Dashboards & Reports

ClearTrial

Risk-Based Monitoring Oracle’s Multi-System Holistic Approach

Provide continuous monitoring of study and

site data

Support multiple methodologies for streamlining site

monitoring through targeted SDV

Single global safety repository ensuring risk

monitoring of subject safety

Access to historical quantitative and qualitative site and investigator

performance;

Drive down costs leveraging Oracle’s pre-

built integrations and open interfaces to

enable RBM Plans

Extensibility to incorporate data and programs from customer

applications in the clinical ecosystem (e.g. EDC, CTMS,

Lab, ePro, eTMF, etc.)

Over 90% OOTB coverage of risk indicators identified in TransCelerate position

paper

Incorporating customer specific systems and processes via

open interfacesEnabling real-time access to actionable insights for decision making through

Mobility

Upfront risk based trial planning via ClearTrial

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

Strategies

By leveraging existing investments and Oracle

technology to drive down costs

While ensuring data integrity, subject safety and compliance


Clinical Development Analytics


Enabling Operational Performance Management from Sites to Execs

ORACLE CLINICAL DEVELOPMENT ANALYTICS

Executive Team

Head of ClinicalOperations

CRA / Data Manager

Clinical Sites

Organizational Progress

Departmental /RegionalProgress

Study Progress

Site Progress


Cloud-Based Delivery of Site Performance and Risk Analysis

• Users access information and analytics through role-based dashboards• Can also publish reports to PDF, distribute, or access through MS Office

Clinical R&D Cloud


Call Site to Understand Low Enrollment

Which sites are slowest recruiters?

Accelerate EnrollmentBusiness

Objectives/Issues

GainInsights

TakeAction

Drill to Site Detail

Which studies are behind?

Is Program on target?

Drill toDetail

CDA’s Interactive Reports Provide Actionable Clinical Insight


SDV Plan updated for study site(e.g. 100% for next 5 subjects)

Study Manager reviewsexceptions daily

Maximize Data QualityBusiness Objectives/

Issues

RiskIdentified

TakeAction

Visit Schedule for siteis updated with new site visit

Event logged on Exception Report

New Site Coordinatormid-study (site turnover)

Event-Driven Clinical Insights via Alerts and Reports


Mobile CRA


Mobile CRA

Mobile CRA VisionEDC

• 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


Mobile CRAMobilizing Clinical Trial Monitoring

Tablet-based Trip ReportingRevolutionizes trip reporting with the ability to download, complete and upload trip reports through a lightweight, intuitive role-focused app on a mobile tablet

Study Alerts and NotificationsAlerts CRAs of key milestones, activities and potential issues for the study sites they are monitoring, enabling them to respond quickly to potential issues that may affect key milestones for the overall study

CTMS Contacts SynchronizationMakes available up-to-date site contact information maintained in your global clinical database so that communication with site via phone, email, or travel is faster and easier

Site-At-A-GlanceProvides study site focused performance indicators in a single view so CRAs have up-to-date site progress information at their fingertips, enabling more efficient, proactive planning and more productive site visits


Mobile CRASimplifying Site Visits

Native Mobile AppProvides an optimum end-user experience benefiting from native capabilities of mobile devices, e.g. GPS, Contacts integration, Messaging, etc.

Study Site Check-InCaptures site check-in details of traveling CRAs for each site visit to be stored on the trip report so compliance to site monitoring requirements can be demonstrated via geo-location information captured while onsite

Simplified Monitoring for Traveling CRAsProvides more efficient workflows for upfront planning, on-site execution and final closeout activities of site visits while facilitating compliance to industry guidance and best practices


Clinical Monitoring Suite

2012 2013 2014

CTMS 2012-IPComplex Trials / Trip Report Workflow

• Support multi-arm flexible trial design• Trip Report Enhancements

• Reviewer/Approver fields & status• New State Model• New Layout / Approvals / Audit Trail views

• Add’l Integration Objects

CDA 2.2Enabling Comprehensive and Detailed Insight

Milestone & cycle time performance management• Key performance indicators & targets at multiple

levels• New executive and region-level dashboards

• Around 50 new pre-built reports and 33 new dashboard pages

Mobile CRA 1.0Guided Site Monitoring

Study Progression Awareness,Streamlined Site Collaboration

CTMS 8.1.1.10 FPOpen UI Certification

• Fresh, Modern UI• Browser Independence• Support for Standards• Mobility Support

Top Add’l Clinical Monitoring Suite

Candidates in 2014 and into 2015

• Study Risk Simulation Tool• Support risk simulation and what-

if scenarios providing scores by risk category based upon historical data during the upfront planning and course of a clinical trial

• ClinOps Cloud Suite Refresh (CTMS 2013 / CDA 3.0 / MCRA 1.3 with InForm and IAMS integration)

• Product Integrations - ClinOps Suite to IAMS - CTMS to QUMAS - CTMS to GreenPhire - CTMS to Financials - CDA to ClearTrial - Mobile CRA to Nuance - Mobile CRA to InForm

CTMS 8.1.1.7 FP• Web Services to support

retrieval of protocol, site, and site visit information

• Capture of geo-location related to Mobile CRA

CTMS 2013-IPTrip Report Simplification

• Data Driven Trip Reports• Configurable on the fly• Real-time response branching• Comprehensive feedback for trip

report reviewPayment Enhancements

• Split payments• Multiple Payees• Revert payments• VAT support

CDA 3.0Support for Sourcing InForm Studies

• InForm 4.6 or later as a transactional source

• DM Metrics aggregated by Region

Mobile CRA 1.2Open SaaG / Alerts

• Configurable Site-at-a-Glance• Open Site-At-A-Glance• Open Alerts

ClinOps Cloud Suite Offering

New subscription-based model for CTMS / CDA / Mobile CRA offering hosted in the Oracle Cloud

Mobile CRA 1.XAndroid Device Support- Phone, Phablet, Tablet

CTMS 2014-x

Risk-Based Monitoring• SDV Plans and Policies• Site Assessment

- New Site Assessment fields - Support new interfaces

• New RBM fields (driven by TransCelerate)

• Integrations - InForm - ClearTrial

CDA 3.1• Oracle Data Integrator (ODI) Support

for ETL in addition to Informatica• Move to ODI for CDA Cloud• Support for ODI and Informatica

on-premise

CDA 3.XSourcing un-sourced Measures

Enhancements of Risk-Based Monitoring• Additional measures from CTMS/EDC• Action Framework for supporting

actions back to source systems • New Monitoring Dashboards/Reports

- User driven thresholds at Study, Project, Indication, TA

Mobile CRA 2.0• Inline InForm SDV

• Single, unified interface for field monitors

• Automated SDV tracking and update to Trip Report

• Nuance Voice Recognition• IAMS integration


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