from vision to implementation: a complete, consistent and compliant etmf
TRANSCRIPT
Pfizer-Wingspan eTMF From Vision to Implementation
Complete, Compliant, Consistent
CBI http://www.cbinet.com/Pharma/Bio Boot Camp on Electronic Trial Master FilesNovember 14-15, 2011Philadelphia, Pennsylvania
transformation
Introductions
Troy Deck Principal at Wingspan [email protected] – work
Susan PaulPfizer, Director of Business TechnologyResponsible for TMF
Agenda
ProjectOrigin
ProductFeatures
&Architecture
ProductScreenShots
ProjectSuccessFactors
Q&A
• Global Pfizer Strategic Innovation programTMF identified as a priority focus area for Pfizer innovation
• Disciplined Requirements ProcessPfizer spends 10 months redesigning business processes and documenting system requirements
• TMF Vendor SelectionPfizer selects Wingspan as the most capable vendor and development partner.
• Wingspan eTMF DesignWingspan spent 5 months refining requirements and producing a highly optimized design.
• Rapid Construction15-20 engineers, 75 joint project team, weekly meetings…
• 12 month Execution with Phased Deliverables• Delivery date set in January 2011 for a production
rollout 2011!
Project Origin
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%)
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.
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.
Study Setup
Quality Control and Activation
Content Capture & Document Scanning
Search & Records
Man-agement
Metrics and Reporting
User Inter-face & Se-
curity
Functional Requirements Workstreams1 Content Capture & Document Scanning 1562 Study Setup 1193 User Interface & Security 1074 Quality Control and Activation 785 Content Search & Records Management 696 Metrics and Reporting 63
592 Functional RequirementsContent Capture, Study Setup, User Interface, Quality Control, Search, Metrics, etc.
313 Non Functional RequirementsCompliance, Performance, Capacity, Support, Infrastructure, etc.
Project Structure 6 Work Streams 905 Requirements
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.
• 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.
Operating Statistics
• NO FOLDER NAVIGATION• 21 CFR Compliant• Anticipates Documents• CTMS Driven• Wizard Based Configuration• Efficient Content Capture and
Quality Control• Metrics Reporting and
Continuous Improvement• Extensible• Robust Capability and
Technology RoadMap
• Robust Alerting• Audit Trails• Renditions• OCR and Barcodes• Search• Site Master File Reconciliation• Milestone Report, Operational
Reporting/Dashboards• Workflows• Role Based Permissions• 100+ screens in system.
Product Features
Receipt&
Scan
• Mail-In Documents• Scan at Office• Upload Files• eMail Attachments
o Wingspan cTMFo Captiva
OCR&
Render
• Document Type• OCR• Deskew • DeSpeckle• Render PDF
o Wingspan cTMFo ADLIB, Captiva
Index& Store
• Add Additional Data
• Validate Study Association
o Wingspan cTMFo Documentum
Monitor& Report
• Percent Complete• Missing Documents• Late Alerts• Issue Reminders• Advanced Search• Metrics
o Wingspan cTMF
QC&
Correct
• Validate Scan• Validate OCR• Validate Field Data• Correct if Needed
o Wingspan cTMF
Process Steps
e
Product Architecture
• Components Scale Independently• Driven by CTMS Integrations• Standards Based• Loosely Coupled• Extensible
ALTERNATE-2eTMF UI (Wingspan)
Content Management
Workflow
Content Search
FAST Search
Clinical Data Warehouse
Rendition
Study Setup Quality Control & Activation
Study CloseoutReporting
eTMF Imaging (EMC)
Authentication Services
Authorization Services
Logging/Auditing
User Interface User Interface
Content Capture & Creation
Search
Data Storage Data Storage
DMF
Data/Content
Application
Presentation
Access Management
Blue
Red
Existing Systems/Components
New Systems/Components
Choose top n Capabilities/Features and provide screen shots for them.
Product Screen Shots
Enterprise Metrics
Study Metrics
Document List View
Messages & Tasks
Document Indexing
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.
Project Success Factors
