The document discusses integrating a clinical trial management system (CTMS) with other clinical systems. It outlines commonly integrated systems like electronic data capture, discusses strategies like data replication vs sharing, and methods like real-time vs batch integration. It then presents a case study of Covidien integrating their Siebel CTMS with Oracle Clinical. They aimed to save time and money by avoiding duplicate data entry and improving visibility. The presentation demonstrates the mapping and automated creation of records between the two systems during the integration process.

1. The Benefits of Siebel
Clinical Integration
Param Singh
with Tricia O’Donnell of Covidien

2. Introductions
• Param Singh
Vice President of Clinical Trial
Management Solutions
BioPharm Systems, Inc.
• Tricia O’Donnell
Director of Central Admin Group
Covidien

3. 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

4. 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

5. 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

6. 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

7. CTMS Integrations
Safety
• Example: Argus
• Kinds of data shared
– Serious adverse event
• Ideal Situation
– Both systems and processes are
stable and clearly defined

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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

14. 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

15. 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

16. 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

17. 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

18. Integration Scope
Oracle
Clinical
Siebel
Clinical
Subjects
Subject Visits
Subject Visit Activities
Patients
Actual Events
DCI/DCM/Questions

19. 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

20. Process Flow Detail
4. Complete mapping between SC & OC
Subject visit
templates - Visits
Subject visit
templates – Visit
Activities
Clinical Planned
Events
DCIs Questions
1:M Mapping 1:M Mapping
1:1 Mapping
Siebel Clinical
Oracle Clinical

21. 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

22. Demo

23. 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

24. Wrap Up / Q&A