This document summarizes three approaches to integrating a clinical trial management system (CTMS) with an electronic data management system (EDMS): 1) The "Mock" approach auto-generates hyperlinks in the CTMS to expected document locations in the EDMS based on folder structure, but there is no true integration or communication between systems. 2) The "EDMS-Driven" approach auto-generates hyperlinks in the CTMS when documents are uploaded to the EDMS, allowing direct links and sharing of metadata between systems. 3) The "CTMS-Driven" approach allows users to upload documents through the CTMS, which then auto-creates corresponding records and hyperlinks in

1. Integrating Your CTMS
with Your EDMS
Param Singh

2. Welcome & Introduction
Param Singh
Vice President of
Clinical Trial Management Solutions
• 10+ years of experience
implementing Siebel Clinical
• Managed over a dozen Siebel Clinical
implementations

3. Today’s Agenda
Time Topic
2:00-2:05 Welcome and Introduction
2:05-2:10 Benefits of CTMS-EDMS Integration
2:10-2:20 3 Approaches to EDMS Integration
• Mock
• EDMS-Driven
• CTMS-Driven
2:20-2:45 Live Demo of 3 Approaches
2:45-3:00 Q&A

4. Benefits of EDMS Integration
• Streamlines document tracking
process
• Reduces data entry error
• Saves time
• Eliminates need to search EDMS
for a document
• Simplifies audits

5. Benefits of EDMS Integration
Example: Trip Report
• Complete
• Review
• Approve
• Archive

6. 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

7. 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

8. 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

9. 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

10. 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.

11. 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

12. 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

13. 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.

14. 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

15. Siebel Clinical ASCEND

16. Questions?

17. Closing
Thank you for attending!
This webinar will be posted on
www.biopharm.com
within 24 hours
psingh@biopharm.com