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Clinical Trial Management & Adverse Event ReportingRachel Yang, M.D. Ph.D., Director, Product StrategyHealth Sciences Global Business Unit (HSGBU)Oracle Switzerland

Adverse Event Reporting/Adverse Event Reporting/PharmacovigilancePharmacovigilance

(Oracle AERS & (Oracle AERS & Siebel AECM)Siebel AECM)

Term Classification / Dictionary Management (TMS)Term Classification / Dictionary Management (TMS)

Life Sciences Data HubLife Sciences Data Hub

Clinical Data Clinical Data Management SystemManagement System

(Oracle Clinical)(Oracle Clinical)

Clinical Trials Management System (Siebel Clinical)Clinical Trials Management System (Siebel Clinical)

Oracle Life Sciences (OLS) Apps

Remote Data Capture (RDC)Remote Data Capture (RDC)

CTMS Definition (1)

• Clinical Trial Management System:• Refers to the integration of planning, execution and

management of clinical trials across the different organizations and partners involved in the process

• The major data points that are captured and integrated by CTMS include:• Patient Data, Budgeting, Billing, Trial Protocol, and

Regulatory Forms and Research• Manage the functions and drive the convergence of

• Trial Management, Site Management, Investigator Management, and Clinical Supply Management

CTMS Definition (2)

• Clinical Trial Management System:• Customizable Software System …to manage the large

amount of data involved with the operation of clinical trials• Maintains and manages the planning, preparation,

performance, and reporting …with emphasis on keeping up-to-date contact information for participants and tracking deadlines and milestones…

• Provides data into a business intelligence system, which acts as a dashboard for trial managers

Why Do We Need CTMS?

• Complex logistic needs • Multi-facets, multi-phasing, spanning multiple organizations and

involving multiple stake holders• Trials are increasingly global in nature

• Variable business processes and operational standards• Need to implement standardized operating procedures (M&A, high

growth)• Long and costly endeavor

• Inefficient process, manual work, long cycle time and cost overrun• Lack of timely insight and to enable better decision making• Regulatory liability• …

Oracle Siebel CTMS Key Capabilities

Siebel CTMS empowers organizations to expedite and better manage clinical trials by:• Enabling efficient planning and tracking of clinical studies

• Improving relationships with investigators

• Enhance productivity and effectiveness

• Visit reporting and issues tracking

• Patient enrollment tracking

• Document tracking

• IEC/IRB approvals

• Budgeting and financials, investigator payments

Global Trial Support

Supports global trials run in multiple countries

Multi-lingual, multi-currency, time/date format time zones

Planning & tracking enrollment at site, region/country, protocol and program

Automatic data (enrollment & Payment) rollup from Site to Region to Protocol and Program

Historical information, performance & assessments

Targeting

Investigator qualification and specialty tracking

Web recruitment

Pre-qualification scripts

Mass mailing and email correspondence

Investigator Screening & Subject Recruitment

Multi-currency site level budgetingSite Contract ManagementFlexible payment on activities, milestones or ad hoc eventsAutomatic payment roll up from Site to Region, Protocol, and ProgramEnable integration with back office financial systems

Site Payments & Contract Management

Monitor trial milestonesSite Initiation/Site CloseoutFirst Subject EnrollmentLast Subject Off Study

Real time subject enrollment tracking at site, region, and protocol levels

Subject status, and status transition dateScreen failure/early termination and reasons

Automatic data rollup from site, region to protocol level

Trial Status Monitoring & Enrollment Tracking

Dynamic, template based visit reportingSite visit trackingStreamlined visit report review and approval flowCentralized follow-up issues trackingVisit report metrics and

analysis

Site Visits & Visit Reports

Automatic Team Assignment & History

Automatic assignment through “Position Rollup”& “Position Rolldown”

Assign a person to a protocol and “roll down”to all its regions and sitesAssign a person to a site, and “roll up” to its region and protocol

Team History provides detailed assignment history

Multi-currency site level budgetingSite Contract ManagementFlexible payment on activities, milestones or ad hoc eventsAutomatic payment roll up from Site to Region, Protocol, and ProgramEnable integration with back office financial systems

Site Payments & Contract Management

Document Tracking Templates providing tracking list for critical documentsSupport document tracking at Site, Region/Country, and Protocol levels; and for Account and Contact.

Sent/receive date, expiration date, etc

CRF Tracking Source document verification date; document retrieval date etc

Document Tracking

Calendar Management

Site Calendar displays all subject visits as well as CRA Site Visits

In Monthly, weekly or daily viewCreate unscheduled visits on calendar

Project Team CalendarAll calendars integrate with Outlook and Lotus Notes

Customer Reported BenefitsReported Benefit Source

Reduced Site Initiation time to 10 weeks from 12 weeks Confidential

Reduced Subject Enrollment time to 16 weeks from 25-30 weeks Confidential

Reduced CRA monitoring effort by 30% Confidential

Reduced system support costs by 50% vs previous custom system Confidential

Reduced man-hours required for investigator payment processing: $500,000/yr Amgen (Forbes, Jan 2001)

Eliminated payments for missed visits: From 3% of payments to 0% Confidential

Reduced monitoring visits by 10%-20% Amgen, Watson

Reduced travel expenses by 15% Confidential

Consolidated real-time view of trial status: Reduced to days from weeks Amgen

Globally standardized processes, enhanced compliance Ingenix/GSK (mergers)

Better and more timely decisions: Qualitative estimates Amgen, TAP, Watson

Supports better customer experience for investigators and sites Amgen (study completed)

Allows for early recognition of progress/ quality issues at sites Amgen, Watson

Oracle Dominates The Enterprise CTMS Market

Siebel CTMS• #1 Market Leader by Frost &

Sullivan• Market share > 80% measured by

new license revenues, > 43% by total installed base.

• Over 42,000 seats of Siebel Clinical licensed to date

• 5 of top 10 Pharmaceutical companies are customers

• J&J, Pfizer, GSK, Roche, and Merck

• 3 top CROs uses Siebel Clinical • PPD, PRA, i3 Research

05000

1000015000200002500030000350004000045000

2001

2002

2003

2004

2005

2006

2007

2008

CummulativeNumber ofSeatsLicensed

Siebel Clinical Customers UsersCustomer Purchase

DateStatus

Amgen (Global) 2000 Live

Ingenix (Global) 2001 Live

Johnson & Johnson OBI (US) 2001 Live

Pfizer (Spain) 2001 Live

Novartis (France) 2002 Live

Novartis (UK) 2002 Live

Pfizer (Italy) 2002 Live

TAP (US) 2002 Live

Profiad (UK) 2002 Acquired

Eli Lilly (US) 2003 Live

Watson Pharma (US) 2001 On-Hold

Schering Plough UK 2002 Live

Quorum Review (US) 2002 Live

Guidant (US) 2003 Acquired

Over 40 installations and 42,000 seats of Siebel Clinical

Customer Purchase Date

Status

Johnson & Johnson PRD (Global) 2003 Live

GlaxoSmithKline (Global) 2003 Live

Aventis (Germany) 2003 Live

Teva (Global) 2004 Live

Takeda Pharmaceuticals (US) 2003 Live

Protein Design Lab (Global) 2004 Live

Novartis US 2005 Live

Shire (Global) 2005 Live

Inveresk (Global) 2004 Live

PPD (Global) 2004 Live

PRA International (Global) 2004 Live

Gilead Sciences (Global) 2004 Live

Duke Clinical Research Institute (US) 2004 Live

Select Siebel Clinical Customers


Status

Roche (Global) 2005 Live

Cordis 2006 Live

Merck 2007 Purchased

Genzyme 2006 Live

Amylin 2006 Live

Alcon 2006 Implementing

Boehringer Ingelheim 2006 Implementing

Merz (Germany) 2007 Implementing

Robarts 2007 Implementing

Jazz Pharmaceuticals 2007 Implementing

Excelixis 2007 Implementing

Siro (India) 2007 Implementing

Kyphon 2007 Implementing



Status

Celgene 2007 Implementing

Schering Plough 2007 Implementing

Imclone 2008 Implementing

RadPharm 2008 Implementing

Covidien 2008 Implementing

Warner Chilcott 2008 Just Purchased

Boston Scientific 2008 Just Purchased

PPC 2009 Just Purchased

Sarah Cannon 2007 Implementing

Depuy 2007 Implementing

Baxter 2007 Implementing


Adverse Event Reporting/Adverse Event Reporting/PharmacovigilancePharmacovigilance

(Oracle AERS & (Oracle AERS & Siebel AECM)Siebel AECM)

Term Classification / Dictionary Management (TMS)Term Classification / Dictionary Management (TMS)

Life Sciences Data HubLife Sciences Data Hub

Clinical Data Clinical Data Management SystemManagement System

(Oracle Clinical)(Oracle Clinical)

Clinical Trials Management System (Siebel Clinical)Clinical Trials Management System (Siebel Clinical)

Oracle Life Sciences (OLS) Apps

Remote Data Capture (RDC)Remote Data Capture (RDC)

Customer Pain Points

• Regulatory obligation• Come from scattered data sources in different flavors:

• Product complaints, medical inquiries, adverse events,• From e-mail, phone, fax, letters, corporate Web site, sales reps, etc.)• Need a cohesive structure that captures complete information in a

timely manner• Disconnected Processes

• Slow or missed follow up, inadequate responses • Inability to analyse safety event as they occur, fail to identify trends and

spot problems sooner• Different tools that don’t talk to each other, tracking complaints and

follow-up work becomes a major obstacle.

Value Proposition

• Regulatory compliance• Streamlined safety reporting process enable closed-

loop reporting, analysis of adverse events or product complaints

• Reduced costs on safety reporting• Execute timely and high-quality investigations,

trending, analyses, regulatory reporting and corrective actions.

Solution Components

CTMS

AIAAIA

DMCS

ETL

Siebel

Contact Center

Med Info

LSH –

consolidate all clinical dataTelephone

Portal

Email

FAXDocument

Mgmt

AERS

Med-Info / ADR Intake

Channels

Signal Detection

HSG

BU A

nalytics

Clinical and PLM Applications

Agile PLM

AECM

Oracle Adverse Event Reporting SystemProvides a Single Repository for all Types of Events

ProductComplaint

AdverseEvent

MedicalQuery

SiebelCall Center

Healthcare Practitioner

Patient/Consumer

Pharmacist

HospitalMedical Center

CAPA** Team

Analysis TeamQuality

Oracle AERS*

Medical Inquiries/Patient Assistance

orDrug Specialist

Single Complaint

& AERepository

Signal Detection Reporting Trending Regulatory

Submission

CreateProduct Issue

Escalation

*Adverse Event Reporting System**Corrective and Preventative Action

Adverse Event and Complaint ManagementMaintains All Adverse Events and Complaints in a Single Repository

• Call Center Triage• Consistent, auditable process supports regulatory requirements• Consistent process improves data quality• Escalation promotes data integrity and history• Assignment manager automatically routes to appropriate

Quality Manager• Adverse Event and Complaint Processing

• Single Repository for all Complaint Information• Auditable, Consistent Process• Data Drives Trending• Supports 21 CFR Part-11 Requirements

• Trending and Communication• Threshold levels can alert appropriate personnel to non-obvious

compliance issues and eliminate regulatory risk • Investigation and CAPA processing can identify and contain

problem before it becomes widespread

Receives auto-alerts triggered by increased frequencies of adverse events for a given product

Uses pre-built queries to identify cases requiring safety surveillance, including those that involve death, overdose, pregnancy, etc.

Builds ad hoc queries as needed and save for re-use to simplify recurring safety surveillance

Uses wizard to determine reportability based on case attributes and product licensing status

Configures AERS workflow to meet business workflow needs

Automates narrative generation to speed report creation

Builds and save queries to simplify creation of recurring periodic reports

Auto-generates standard regulatory reports such as MedWatch 3500A,IND Safety Update, and CIOMS I

Submits reports via E2B interchange

Tracks reports submitted to regulators, distributors, or partners

ReportMonitor & Decide

!!

Oracle Adverse Event Reporting SystemEnable Active Adverse Events Monitoring & Timely Report Submission

Case Management

All product types, all case types in single application (AEs, PCs, MIs)Integrates data from external data sources and applicationsWorkflow, including e-signatures and multiple workflows by caseAutomates: Auto-narrative generation, Auto-labeledness, Rollup, more..

Oracle Adverse Event Reporting System Integrated Solution With Clinical Data Management

Oracle Clinical

Codelists, reference data Patient demographics

Common dataCreate AERS Case

Oracle Remote Data Capture

Oracle ThesaurusManagement System

Oracle Adverse Events

Reporting System

Reports

Data Extract

Discrepancies

Reconciliation

Common coding standards

What Customers are Achieving in Clinical Trials…

garnered up to 50% productivity gains in study program development by leveraging previous clinical trials with Oracle clinical applications

reduced time to create management reports from 3 days to 1-5 minutes and reduced time range of monitoring visit reports forwarded for review from 10-20 working days to 5-10 working days with Oracle Clinical Trial Management System

average time to database lock - 2 to 4 weeks, reduction in data management discrepancy cost (80 to 90%) with Oracle Remote Data Capture

The Oracle Difference

Only Oracle…

• Offers complete clinical data management, electronic data capture, clinical trial management and adverse event reporting solutions

• Offers the only application for aggregation of clinical and non-clinical data with near real time analysis and reporting in a regulatory compliant environment

• Offers a comprehensive set of solutions that span the breadth oflife sciences value chain

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