integrating your ctms with your edms

Integrating Your CTMS

with Your EDMS

Param Singh

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

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

Benefits of EDMS Integration

• Streamlines document tracking process

• Reduces data entry error

• Saves time

• Eliminates need to search EDMS for a document

• Simplifies audits

Benefits of EDMS Integration

Example: Trip Report

• Complete

• Review

• Approve

• Archive

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

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

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

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


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.


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

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


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.


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

Siebel Clinical ASCEND

Questions?

Closing

Thank you for attending!

This webinar will be posted on www.biopharm.com

within 24 hours

[email protected]

integrating your ctms with your edms

Technology