1. Pfizer-Wingspan eTMF
From Vision to Implementation
Complete, Compliant, Consistent
transformation
CBI http://www.cbinet.com/
Pharma/Bio Boot Camp on Electronic Trial Master Files
November 14-15, 2011
Philadelphia, Pennsylvania

2. Introductions
Troy Deck
Principal at Wingspan
tdeck@wingspan.com
610-941-6508 – work
Susan Paul
Pfizer, Director of Business Technology
Responsible for TMF

3. Agenda
Product
Product Project
Project Features
Screen Success Q&A
Origin &
Shots Factors
Architecture

4. Project Origin
• Global Pfizer Strategic Innovation program
TMF identified as a priority focus area for Pfizer innovation
• Disciplined Requirements Process
Pfizer spends 10 months redesigning business processes and documenting system requirements
• TMF Vendor Selection
Pfizer selects Wingspan as the most capable vendor and development partner.
• Wingspan eTMF Design
Wingspan spent 5 months refining requirements and producing a highly optimized design.
• Rapid Construction
15-20 engineers, 75 joint project team, weekly meetings…
• 12 month Execution with Phased Deliverables
• Delivery date set in January 2011 for a production
rollout 2011!

5. Complete
• At any point in time show what is missing, what is
coming due, what is in workflow.
– Dashboards
– Reporting
• Display how document manifest has changed
over time for a study, country, site.
• Display process owner group and which
documents they are responsible for.
• What is the rejection rate (goal is 4
sigma…99.38%)

6. Consistent
• Document type audit. In country level
documents it went from 300 documents to 1.
• The Master TMF Manifest has a process in
which it can be modified or changed.
• 100% QC on all documents.

7. Compliant
• Are all required documents present?
• Audit ready at anytime.
• 21 CFR Part 11 compliant.
• New role: TMF Study Owner – Responsible for
the electronic Study TMF.

8. Project Structure
6 Work Streams
905 Requirements
Functional Requirements Workstreams
1 Content Capture & Document Scanning 156
2 Study Setup 119
3 User Interface & Security 107
4 Quality Control and Activation 78
5 Content Search & Records Management 69
6 Metrics and Reporting 63
User Interface
& Security Study Setup
592 Functional Requirements Metrics and
Content Capture, Study Setup, User Interface, Quality Quality
Reporting
Control, Search, Metrics, etc. Control and
Activation
Search &
313 Non Functional Requirements Records Content
Compliance, Performance, Capacity, Support, Management Capture &
Infrastructure, etc. Document
Scanning

9. Development Statistics
• Over 30 development man years in the application.
• Two teams of testers (2 man years of testing)
– Team 1 from Wingspan – 6 Testers
– Team 2 from Pfizer – 12-14 Testers
– 3,000+ hours of testing
• 8 development milestones set in January 2011. Met every
milestone date. Production delivered November 11, 2011
at 11:11am. (4 days earlier than original date).
• Design document approaching 1,000 pages.
• Goal for IT was to make sure no built in Pfizerisms that
cannot be changed via configuration. Pfizer wants this to
become a product that is the standard for eTMF.

10. Operating Statistics
• Supports 1000 concurrent users
• 1,350 Studies per year by 2015, unlimited
studies total
• 240,000 Documents per month
• 60+ Countries with Access
• 600+ Document types
• Note: The most successful large scale
program in R&D at Pfizer in over 10 years.

11. Product Features
• NO FOLDER NAVIGATION • Robust Alerting
• 21 CFR Compliant • Audit Trails
• Anticipates Documents • Renditions
• CTMS Driven • OCR and Barcodes
• Wizard Based Configuration • Search
• Efficient Content Capture and • Site Master File Reconciliation
Quality Control • Milestone Report, Operational
• Metrics Reporting and Reporting/Dashboards
Continuous Improvement • Workflows
• Extensible • Role Based Permissions
• Robust Capability and • 100+ screens in system.
Technology RoadMap

12. Process Steps
Receipt OCR QC
Index Monitor
& & &
& Store & Report
Scan Render Correct
• Mail-In Documents • Document Type • Validate Scan • Add Additional • Percent Complete
• Scan at Office • OCR • Validate OCR Data • Missing Documents
• Upload Files • Deskew • Validate Field Data • Validate Study • Late Alerts
• eMail Attachments • DeSpeckle • Correct if Needed Association • Issue Reminders
• Render PDF • Advanced Search
• Metrics
o Wingspan cTMF o Wingspan cTMF o Wingspan cTMF o Wingspan cTMF o Wingspan cTMF
o Captiva o ADLIB, Captiva o Documentum
e

13. Product Architecture
• Components Scale Independently
• Driven by CTMS Integrations
• Standards Based
• Loosely Coupled
• Extensible

14. ALTERNATE-2
eTMF UI (Wingspan) eTMF Imaging (EMC)
Access Authentication Services
Management
Authorization Services
Presentation User Interface User Interface
FAST Search Study Setup Quality Control & Content Capture & Creation
Activation
Application DMF
Reporting Study Closeout Search
Workflow
Content Search Logging/Auditing
Rendition
Data Storage Data Storage
Data/Content
Clinical Data Warehouse
Content Management
Blue Existing Systems/Components
Red New Systems/Components

15. Product Screen Shots
Choose top n Capabilities/Features and provide screen
shots for them.

16. Enterprise Metrics

17. Study Metrics

18. Document List View

19. Messages & Tasks

20. Document Indexing

21. Project Success Factors
 Make the project fixed bid.
 Builds discipline and accountability.
 Manage Scope, Manage Scope, Manage Scope
 84 Change Orders evaluated. 4 Approved for R1, 8 Approved for R1.1
 CR Filter
 Is their a work around?
 Is it required for regulatory?
 Lock the requirements
 Start with really smart driven people.
 Pfizer TMF Process Owner: Ivan Walrath.
 Work with really smart driven people.
 Wingspan & Pfizer team
 Finish with really smart driven people.
 Wingspan & Pfizer team – Consistency of personnel on the project. No change of personnel
on Pfizer’s or Wingspan’s team from the start.

22. Questions?
Susan Paul Troy Deck
tdeck@wingspan.com