Siebel Clinical Integration with other systems

T11 September 22, 2013

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

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

Agenda of Topics
Topics Integration Strategies Integration Methods Common Integrations with CTMS Overview Approach Demo

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

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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Integration Approach: CDM System

Oracle Clinical
Patients Actual Events DCI/DCM/Questions

Siebel Clinical
Subjects Subject Visits Subject Visit Activities

Overall Process Flow : CDM System Integration

1. 2. 3. 4. 5. 6. Set up study in OC Set up study in SC Select study to be integrated Complete mapping between SC(SVT)&OC Activate study in SC to bring in integration data 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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Process Flow Detail

4. Complete mapping between SC & OC

Subject visit templates Visit Activities
1:M Mapping 1:M Mapping

Siebel Clinical

Subject visit templates - Visits

1:1 Mapping

Oracle Clinical
Clinical Planned Events DCIs Questions

Demo

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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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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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Benefits of EDMS Integration

Example: Trip Report

Complete Review Approve Archive

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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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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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Mock Approach
Pros Inexpensive and quick to implement
Add code behind one field

Cons Less precise

Points to folder, not document

Cannot tell whether document has truly been uploaded to EDMS

Populates as soon as record is created in CTMS

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Demo

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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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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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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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Demo

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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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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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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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Demo

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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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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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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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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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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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Wrap Up / Q&A

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