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

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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

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

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

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

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

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

Detailed Documentation CSC Best Practices EDM Reference Model

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