The Benefits of Siebel

Clinical Integration

Param Singh with Tricia O’Donnell of Covidien

Introductions

• Param Singh Vice President of Clinical Trial Management Solutions BioPharm Systems, Inc.

• Tricia O’Donnell Director of Central Admin Group Covidien

Today’s Agenda

Time Topic

1:00-1:05 Welcome and Introductions

1:05-1:15 CTMS Integrations - Commonly integrated systems - Kinds of data shared - Ideal situation for each integration

1:15-1:20 Strategies and Methods - Data Replication vs. Data Sharing - Real-Time vs. Batch

1:20-1:30 Covidien Case Study

1:30-1:50 Covidien Integration Demo

1:50-2:00 Wrap Up / Q&A

CTMS Integrations

Clinical Data Management (CDM) Electronic Data Capture (EDC)

• Example: Oracle Clinical / RDC

• Kinds of data shared

– Subject

– Subject visit

• Ideal Situation

– Both systems and processes are stable and clearly defined

CTMS Integrations

Interactive Voice Response (IVR)

• Example: United BioSource Corporation (UBC)

• Kinds of data shared

– Subject

– Subject visit

• Ideal Situation

– XML based IVR system to ensure no point-to-point

CTMS Integrations

Financial

• Example: SAP Enterprise Resource Planning (ERP) Financials

• Kinds of data shared

– Payment requests

– Details about processed payments

• Ideal Situation

– Entire organization uses single financial system and process

CTMS Integrations

Safety

• Example: Argus

• Kinds of data shared

– Serious adverse event

• Ideal Situation

– Both systems and processes are stable and clearly defined

CTMS Integrations

Electronic Document Management (EDM)

• Example: Documentum

• Kinds of data shared

– Electronic document

• Ideal Situation

– Web-based system

– Clinical hierarchy in both systems is similar

CTMS Integrations

Clinical Data Warehouse

• Example: Oracle Business Intelligence Enterprise Edition (OBIEE)

• Kinds of data shared

– Key metrics

– Performance indicators

• Ideal Situation

– Ample data in source system

– Key performance indicators identified

CTMS Integrations

CRO System

• Example: Clinical Trial Management System (CTMS)

• Kinds of data shared

– Site

– Subject

– Subject visit

• Ideal Situation

– Incremental loads

– No point-to-point

Today’s Agenda

Time Topic

1:00-1:05 Welcome and Introductions

1:05-1:15 CTMS Integrations - Commonly integrated systems - Kinds of data shared - Ideal situation for each integration

1:15-1:20 Strategies and Methods - Data Replication vs. Data Sharing - Real-Time vs. Batch

1:20-1:30 Covidien Case Study

1:30-1:50 Covidien Integration Demo

1:50-2:00 Wrap Up / Q&A

Integration Strategies

• Data Replication Copy data between applications to keep data synchronized in both

• Data Sharing Access data in another application without replicating any data

Integration Methods

• Real-Time Changes made to data in source system are immediately reflected in target system

• Batch Scheduled at specific intervals or triggered by specific actions

Today’s Agenda

Time Topic

1:00-1:05 Welcome and Introductions

1:05-1:15 CTMS Integrations - Commonly integrated systems - Kinds of data shared - Ideal situation for each integration

1:15-1:20 Strategies and Methods - Data Replication vs. Data Sharing - Real-Time vs. Batch

1:20-1:30 Covidien Case Study

1:30-1:50 Covidien Integration Demo

1:50-2:00 Wrap Up / Q&A

Covidien Case Study

Business Situation

• Two global systems (Siebel Clinical CTMS and Oracle Clinical CDMS)

• Duplicate data entry

• Human error

• Extra time and resources needed to enter, review, and clean data

• Delayed investigator payment process

• Lack of visibility into comprehensive clinical trial data

Covidien Case Study

Desired Outcomes

• Save time

• Save money

• Reallocate resources to other tasks

• Improve relationships with investigators

• Improve methods for planning and managing clinical trials

Solution:

Integrate OC/RDC and SC

OC/SC Terminology

Oracle Clinical Siebel Clinical

Site Account

Investigator Contact

Clinical Study Protocol

Study Site Site

Clinical Planned Events

SVT – Visits

DCIs & Questions SVT – Visit Activities

Patient Subject

Clinical Planned Event/ Actual Event

Subject Visit

CRFs (DCIs/Questions)

Subject Visit Activities

Integration Scope

Oracle Clinical

Siebel Clinical

Subjects Subject Visits Subject Visit Activities

Patients Actual Events DCI/DCM/Questions

Overall Process Flow

1. Set up study in OC

2. Set up study in SC

3. Select study to be integrated

4. Complete mapping between SC(SVT)&OC

5. Activate study in SC to bring in integration data

6. Interface auto-creates Subject, Subject Visit, Subject Visit Activity, CRF, SAE*, and Protocol Deviation* records

7. Review and adjust integration data as needed based on the error/change logs in new Integration Admin view

Process Flow Detail

4. Complete mapping between SC & OC

Subject visit

templates - Visits

Subject visit

templates – Visit

Activities

Clinical Planned

EventsDCIs Questions

1:M Mapping 1:M Mapping1:1 Mapping

Siebel Clinical

Oracle Clinical

Today’s Agenda

Time Topic

1:00-1:05 Welcome and Introductions

1:05-1:15 CTMS Integrations - Commonly integrated systems - Kinds of data shared - Ideal situation for each integration

1:15-1:20 Strategies and Methods - Data Replication vs. Data Sharing - Real-Time vs. Batch

1:20-1:30 Covidien Case Study

1:30-1:50 Covidien Integration Demo

1:50-2:00 Wrap Up / Q&A

Demo

Benefits of Covidien Integration Approach

• Reduced manual entry of Clinical Data in multiple systems

• Enhanced data consistency across CTMS and OC/RDC by minimizing manual errors

• Reduced the overall timeline for Study Management

• Ability to integrate selective studies

Wrap Up / Q&A