1. FirstPoint and FirstDoc Application of the DIA EDM Reference Model
Jennifer Wemstrom, Principal, Solution Specialist
CSC Life Sciences
February 11, 2009

2. Disclaimer
The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. (“DIA”), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated.
These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners.
Change to: In addition to DIA’s continued presence in North America, Europe, and Japan, DIA also serves the following regions:
India (remove italics from Mumbai, India, October 16-18, 2006)
Middle East (7th Annual Middle East Regulatory Conference, Dubai, UNITED ARAB EMIRATES, November 14-16, 2006)
China
Remove Central and Eastern Europe since it’s referenced at the top.
Latin America 2

3. CSC’s EDM Products FirstDoc FirstPoint
Based on EMC’s Documentum Platform
FirstPoint
Based on Microsoft’s SharePoint Platform
Both applications are preconfigured with CSC’s “Best Practices” for Life Sciences which are analogous to the EDM Reference Model

4. Best Practices History
CSC Best Practices developed over a decade of over 45 implementations
Most recently in the last 2-3 years, several clients contributed directly to the revising of the Best Practices model
Abbott, sanofi-aventis, Schering-Plough, Gilead, Amgen, Baxter, Takeda
The commonalities of their implementations were built back into the model
Model has been “road tested” with numerous implementations, has reduced analysis timelines and proven successful with business users in production

5. Best Practices vs. EDM Reference Model
A high level analysis shows the models very well aligned in both products
FirstDoc/DCTM
EDM Reference Model
CSC Best Practices
Domain
Document Type
Group
Document Subtype
Artifact
Document Unit
FirstPoint/MSFT
EDM Reference Model
CSC Best Practices
Domain
Library
Group
Content Type
Artifact
Document Type

6. Best Practices vs. EDM Reference Model
A detailed analysis also shows models very closely aligned
Clinical: Nearly identical
Nonclinical: Nearly identical except optional properties of Study Director and Study Facility
CMC (Quality): Nearly identical except optional property of Impurity
Regulatory Administrative: Similar but slightly different approach which contains a single global model encompassing US, EU, Japan, Canada and Australia

7. Best Practices vs. EDM Reference Model
While the artifacts are almost identical in each domain, CSC’s best practices model has more granular Groups than the EMD Reference Model
This is so that different properties can be applied at the Group level. For example, a Study Protocol is a different document Group than a Study Report. This is so that an EU Protocol can have a EUDACT #, while a Study Report can have a Type of Report such as Interim, Final, etc.
In all cases, the CSC Best Practices Model contains all the artifacts, properties, and valid values recommended by the EDM Reference Model and contains additional properties
Clients can choose to not use additional properties if desired
CSC’s model contains a TMF Domain, and is offered in two “flavors” one combined with Clinical and one stand alone

8. FD & FP Value Add Using the EDM Reference Model
Highly configurable solutions that can adapt to changes in the model or client requested changes
Product Dictionaries and Guided Paths which relate and filter controlled values and client specific metadata based on user input
Security models based on Reference Model Metadata
Preconfigured property mapping with industry leading publishing vendors for auto eCTD Outline creation
Dynamic Views tailored to user preferences using both artifacts and metadata

9. Detailed Documentation
CSC Best Practices
EDM Reference Model

10. Future Steps
Implement property changes to align exactly with Reference Model
Add optional EMD Reference Model properties not in CSC BP
Add optional “Group” property to map where Groups and Subtypes do exactly not align
Targeted for FirstDoc R&D 6.1 and FirstPoint 2.0
Implement Pharmacovigilance Model
Implement Labeling Model
CSC has internal draft model targeted for FirstDoc 6.1 release and FirstPoint 2.0 release but will look to align EDM Reference Labeling Model when released
CSC’s Labeling Focus Group
Active participation in the DIA EDM Reference Model working group