Siebel CTMS Integration with Clinical and Safety Systems

1. Siebel Clinical Integration with other
systems
T11
September 22, 2013
Param Singh
Vice President of
Clinical Trial Management Solutions
BioPharm Systems, Inc.
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2. Welcome & Introductions
Param Singh
Vice President of
Clinical Trial Management Solutions
• 4+ years with BioPharm
• 11+ years of experience
implementing Siebel Clinical
• 15+ Siebel Clinical implementations
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3. Agenda of Topics
Topics
Integration Strategies
Integration Methods
Common Integrations with CTMS
Overview
Approach
Demo
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4. 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
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5. 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
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6. CTMS Integrations
Clinical Data Management (CDM) Electronic
Data Capture (EDC)
• Example: Oracle Clinical / RDC
• Kinds of data shared
– Subjects/statuses
– Subject visits/procedures
– CRF/SAE/PD
• Ideal Situation
– Both systems and processes are stable and clearly
defined
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7. Integration Approach: CDM System
Oracle
Clinical
Siebel
Clinical
Subjects
Subject Visits
Subject Visit Activities
Patients
Actual Events
DCI/DCM/Questions
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8. Overall Process Flow : CDM System Integration
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
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9. 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
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10. Demo
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11. 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
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12. Benefits of EDMS Integration
• Streamlines document tracking process
• Reduces data entry error
• Saves time
• Eliminates need to search EDMS
for a document
• Simplifies audits
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13. Benefits of EDMS Integration
Example: Trip Report
• Complete
• Review
• Approve
• Archive
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14. Mock Approach
What It Does
• Auto-generates a hyperlink in CTMS to the
expected location of the document in EDMS,
based on the folder structure in CTMS
• Not a true integration; no communication between
CTMS and EDMS
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15. Mock Approach
How It Works
1. Create document tracking record in CTMS.
2. URL field auto-generates hyperlink consisting of
base URL (such as www.documentum.com)
PLUS protocol/site location in CTMS.
3. Example: http://sharepoint.biopharm.com/CTMS/Prot_x123/Site101
Note: Requires same folder structure in EDMS as CTMS
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16. Mock Approach
Pros
• Inexpensive and quick to implement
– Add code behind one field
Cons
• Less precise
– Points to folder, not document
• Populates as soon as record is created in CTMS
– Cannot tell whether document has truly been uploaded
to EDMS
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17. Demo
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18. EDMS-Driven Approach
What It Does
• Auto-generates a hyperlink in CTMS when the
document is uploaded into EDMS
• Can also share metadata about the document
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19. EDMS-Driven Approach
How It Works
1. Document tracking record is created in CTMS,
and includes a document “code.”
2. Document is uploaded to EDMS and required
metadata is entered, including document code.
3. Interface finds corresponding record in CTMS
and populates URL field with link to document in
EDMS.
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20. EDMS-Driven Approach
Pros
• Links directly to the document
• Easy to see which documents have / have not
been uploaded to EDMS
• Can share document metadata in both directions
Cons
• Requires document tracking record to exist in
CTMS ahead of time
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21. Demo
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22. CTMS-Driven Approach
What It Does
• Through CTMS, auto-creates a document record
in CTMS and EDMS
• Auto-populates a link in CTMS to record in EDMS
• Can also share metadata about the document
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23. CTMS-Driven Approach
How It Works
1. Upload document to CTMS as attachment and
enter required metadata.
2. Click [SendFile] button.
– Creates corresponding record in EDMS
– Creates corresponding document tracking record in
CTMS with link to record in EDMS
3. Maintain document in EDMS.
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24. CTMS-Driven Approach
Pros
• Creates all document records simultaneously
• Hyperlink always points to same location in
EDMS, so always links to most current version
Cons
• Original version of document always available in
CTMS, which could be a compliance risk
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25. Demo
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26. CTMS Integrations
Interactive Voice Response (IVR)
• Example: United BioSource Corporation (UBC)
• Kinds of data shared
– Subjects/Statuses
– Subject visit/procedures
• Ideal Situation
– XML with Web Services based IVR system to ensure
no point-to-point
*Note – Approach is similar to CDM integration
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27. 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
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28. CTMS Integrations
Safety
• Example: Argus
• Kinds of data shared
– Serious adverse event
• Ideal Situation
– Both systems and processes are stable and clearly defined
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29. 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
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30. 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
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31. Wrap Up / Q&A
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