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Andrea Kozak Sr. Project Manager Takeda Pharmaceuticals North America Allyn Mather Business Analyst...
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Transcript of Andrea Kozak Sr. Project Manager Takeda Pharmaceuticals North America Allyn Mather Business Analyst...
Andrea KozakSr. Project ManagerTakeda Pharmaceuticals North America
Allyn MatherBusiness AnalystTakeda Pharmaceuticals North America
Scanning the Clinical Master File High
Volume, High Value
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!
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
Overview
– Introduction• The Company• The Project & Vision
– Business Rationale• The Drivers • The Benefits
– Technology• The Old Way• The New Solution• Technology Detail• Lessons Learned
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
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
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
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.
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
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
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
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
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
The Old Form
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
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
The New Form
The New Form Continued
Patch CodeDocument Separation
2D Bar Code
Human Readable Metadata
Technology Detail (Behind the Scenes)
Processing Processing RulesRules
Value Value AssistanceAssistance
XML ExportXML Export
JSP JSP WebformWebform 2D Barcode 2D Barcode
Cover SheetCover Sheet
Technology Detail
Web form values maintained in Repository
Daily job exports data into XML file
Dynamic Web Form Values Populated
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
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……
Q&A
Questions?
Thoughts?
Clarifications?
Thank You!
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