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Andrea KozakSr. Project ManagerTakeda Pharmaceuticals North America
Allyn MatherBusiness AnalystTakeda Pharmaceuticals North America
Scanning the Clinical Master File High
Volume, High Value
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Scanning? Yes, Scanning!
• The “Paperless Office” has a new definition• The paper hasn’t gone away!• Now we convert into a format to better
enable distribution, sharing and yes, the printing of more paper!
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The Clinical Master File
• Documents required by FDA to support Clinical Research
Documents Submitted to FDA Already stored in
Repository
Additional Supportive Documents
Clinical Master File
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Overview
– Introduction• The Company• The Project & Vision
– Business Rationale• The Drivers • The Benefits
– Technology• The Old Way• The New Solution• Technology Detail• Lessons Learned
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Takeda Pharmaceuticals North America
Founded: 1998 – Licolnshire, IL (Chicago)Wholly owned subsidiary of Takeda Pharmaceuticals Company, Ltd., founded 1781, Osaka, Japan
Primary Business: Pharmaceutical Products
Employees: 2,100 (US) – 710 home office & 1,390 field sales
Areas of focus: Diabetes, sleep, cardiovascular disease, central nervoussystem disorders, bone and joint diseases, allergic diseases and infectious diseases
Current products: ACTOS (pioglitazone HCI), Rozerem (Ramelteon), Actoplusmet
Business Model: Research and Development Primarily Outsourced
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Key IT Strategies
• Buy versus Build• Look for enterprise solutions rather than best of breed• Leverage and extend existing software assets, where possible• Release Incrementally• Emphasize business involvement• Listen to your customers
…and
• Partner with Implementation Vendors
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Project Highlights
• Tasked With– Integrating Clinical Master File (CMF) into existing repository– Creating high throughput batch scanning capabilities– Upgrading Documentum software from 4.X to 5.X– Develop functional enhancements– Validate all changes
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Vision
Change/Enhance ApproveRoute ArchivePublishCreate/Capture
Content Lifecycle
Author from Author from TemplateTemplate
Import from Import from CROCRO
Fax/ScanFax/Scan
Real-Time Real-Time CollaborationCollaboration
HyperlinkHyperlinkBookmarkBookmark
ElectronicElectronicApprovalApproval
Clinical
Regulatory
Quality
Non-Clinical
Publications
Labeling
Outlook email Outlook email NotificationNotification
Deploy an Integrated Document Management System to enable storage, access and management of all TGRD research and submission documents across the enterprise.
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Business Drivers
• Electronic Copy of Paper Files– File Room not environmentally controlled– Significant liability if documents were damaged or destroyed– Older files stored offsite
• High Demand for Documents– Manual Receipt, cataloging and distribution– Critical, time sensitive documents– Multiple departments need copies of same documents– Demand was projected to continue to increase
• More compounds + More studies = More documents• Continued R&D growth
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Benefits
• Increased scanner productivity– Increased capacity of scanning personnel – Parallel processing enabled – scanning & indexing
• Scalable solution – Ability to add new document categories quickly
• Ease validation effort (system maintenance vs. code change)• Remove IT bottleneck by training super users to maintain
• Online access to all documents by R&D organization– Not just submission documents anymore!
• Self service document access
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The Solution
• Integrate Clinical Master File documents into existing repository structure– Additional attributes added– Watermark added to CMF documents
• Re-engineer current InputAccel Processes– Reduce Capture flows from 21 to 1– Reconfigure IA processes to gain efficiencies– Remove need for hard coded processes
• Implement 2D bar code technology leveraging XML– Electronic online submission form – Single metadata entry– Document categories and meta data stored/controlled in repository– XML file created to enable dynamic web form
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Old Scan Process
One DocumentOne Document(No Supplemental Documents)(No Supplemental Documents)
ScanningScanning
User selected 1 of 21 different processes based on appropriate object type and folder location
Image Enhance
Full Page OCR
Clinical
Regulatory
Quality
Non-Clinical
Publications
Labeling
Indexing
PDF Export DCTM Export
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Challenges of the Old Scan Process
• Highly dependent on hand-written “Document Attribute” form to supply metadata
• Manual indexing process (5-10 attributes/document)• Limitation on # of documents scanned in a batch = 1 • Manually deleting blank pages• QA Step in Documentum• No metric collection
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The Old Form
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New Scan Process
BatchBatchCover Sheet & Cover Sheet &
DocumentDocument
Batch Batch ScanningScanning
Re-ScanningRe-Scanning
Image and Image and Text QCText QC
Image EnhanceDespeck, Deskew
Barcode Recognition
AutoAnnotateApply Stamp
No StampNo Stamp
Rescan Rescan RequiredRequired
Hold, Delete EmptiesDelete Batch & Cover Sheets
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New Scan Process Continued
Admin Admin QueueQueue
Full Page OCR PDF Export DCTM Export
Clinical
Regulatory
Quality
Non-Clinical
Publications
Labeling
Statistics Export
Statistics Statistics DBDB
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The New Form
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The New Form Continued
Patch CodeDocument Separation
2D Bar Code
Human Readable Metadata
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Technology Detail (Behind the Scenes)
Processing Processing RulesRules
Value Value AssistanceAssistance
XML ExportXML Export
JSP JSP WebformWebform 2D Barcode 2D Barcode
Cover SheetCover Sheet
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Technology Detail
Web form values maintained in Repository
Daily job exports data into XML file
Dynamic Web Form Values Populated
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Lessons Learned
• Hard to teach an old dog new tricks– Change of paradigm– More Utilization of DocXperts
• Beware of the “Back” button…a web application is different than browsing the web for information
– Educate users on application dos and don’ts
• A bar code is only as good as the printer that prints it– Some things you can’t control
• The more information…the bigger the bar code…size does matter!– Use real life examples during initial testing– Integration testing is key
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What does the future hold?
• Achieving fully distributed scanning– CRO fax-scan
• Sites scan content directly into repository via fax– Internal copy-scan
• Internal personnel scan directly into repository via copier
The possibilities are endless……
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Q&A
Questions?
Thoughts?
Clarifications?
Thank You!
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Presentations Will Be Available on the Momentum Las Vegas Website www.momentumlive.com
Password: jackpot
More Questions? Meet the Speakers Mixers
TuesdayWednesday Thursday
Solutions Expo Hall – Level 1Solutions Expo Hall – Level 1South Pacific Ballroom – N. Conf. Center
6:00 pm – 7:00 pm 5:00 pm – 6:00 pm8:00 am – 9:00 am