The Benefits of Siebel Clinical Integration
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Transcript of The Benefits of Siebel Clinical Integration
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