2013 OHSUG - Siebel Clinical Integration with Other Systems

Siebel Clinical Integration with other

systems

T11

September 22, 2013

Param Singh Vice President of

Clinical Trial Management Solutions

BioPharm Systems, Inc.

1

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

2

Agenda of Topics

Topics

Integration Strategies

Integration Methods

Common Integrations with CTMS

Overview

Approach

Demo

3

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

4

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

5

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

6

Integration Approach: CDM System

Oracle Clinical

Siebel Clinical

Subjects Subject Visits Subject Visit Activities

Patients Actual Events DCI/DCM/Questions

7

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

8

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

9

Demo

10

CTMS Integrations

Electronic Document Management (EDM)

• Example: Documentum


– Electronic document

• Ideal Situation

– Web-based system

– Clinical hierarchy in both systems is similar

11

Benefits of EDMS Integration

• Streamlines document tracking process

• Reduces data entry error

• Saves time

• Eliminates need to search EDMS

for a document

• Simplifies audits

12

Benefits of EDMS Integration

Example: Trip Report

• Complete

• Review

• Approve

• Archive

13

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

14

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

15

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

16

Demo

17

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

18


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.

19


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

20

Demo

21

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

22


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.

23


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

24

Demo

25

CTMS Integrations

Interactive Voice Response (IVR)

• Example: United BioSource Corporation (UBC)


– 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

26

CTMS Integrations

Financial

• Example: SAP Enterprise Resource Planning

(ERP) Financials


– Payment requests

– Details about processed payments

• Ideal Situation

– Entire organization uses single financial system and

process

27

CTMS Integrations

Safety

• Example: Argus


– Serious adverse event

• Ideal Situation

– Both systems and processes are stable and clearly defined

28

CTMS Integrations

Clinical Data Warehouse

• Example: Oracle Business Intelligence Enterprise

Edition (OBIEE)


– Key metrics

– Performance indicators

• Ideal Situation

– Ample data in source system

– Key performance indicators identified

29

CTMS Integrations

CRO System

• Example: Clinical Trial Management System

(CTMS)


– Site

– Subject

– Subject visit

• Ideal Situation

– Incremental loads

– No point-to-point

30

Wrap Up / Q&A

31

Technology

2013 OHSUG - Siebel Clinical Integration with Other Systems