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Param Singh
Vice President of Clinical Trial Management Solutions BioPharm Systems, Inc.
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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Oracle Clinical
Patients Actual Events DCI/DCM/Questions
Siebel Clinical
Subjects Subject Visits Subject Visit Activities
Siebel Clinical
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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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
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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
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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
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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