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Scanning the Clinical Master File High Volume, High Value

Scanning the Clinical Master File High Volume, High Value. Andrea Kozak Sr. Project Manager Takeda Pharmaceuticals North America. Allyn Mather Business Analyst Takeda Pharmaceuticals North America. Scanning? Yes, Scanning!. The “Paperless Office” has a new definition

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Scanning the Clinical Master File High Volume, High Value

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  1. Scanning the Clinical Master File High Volume, High Value Andrea Kozak Sr. Project Manager Takeda Pharmaceuticals North America Allyn Mather Business Analyst Takeda Pharmaceuticals North America

  2. 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!

  3. Additional Supportive Documents Clinical Master File Documents Submitted to FDA Already stored in Repository The Clinical Master File • Documents required by FDA to support Clinical Research

  4. Overview • Introduction • The Company • The Project & Vision • Business Rationale • The Drivers • The Benefits • Technology • The Old Way • The New Solution • Technology Detail • Lessons Learned

  5. 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 nervous • system 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

  6. Partner with Implementation Vendors 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

  7. 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

  8. Clinical Regulatory Quality Non-Clinical Publications Labeling Real-Time Collaboration Hyperlink Bookmark Outlook email Notification Electronic Approval Fax/Scan Import from CRO Author from Template Archive Create/Capture Change/Enhance Route Approve Publish ContentLifecycle Vision Deploy an Integrated Document Management System to enable storage, access and management of all TGRD research and submission documents across the enterprise.

  9. 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

  10. 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

  11. 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

  12. Clinical Regulatory Quality Non-Clinical Publications Labeling Scanning Old Scan Process User selected 1 of 21 different processes based on appropriate object type and folder location One Document (No Supplemental Documents) Image Enhance Indexing Full Page OCR PDF Export DCTM Export

  13. 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

  14. The Old Form

  15. Batch Cover Sheet & Document Image and Text QC Batch Scanning Re-Scanning Hold, Delete Empties Delete Batch & Cover Sheets Image Enhance Despeck, Deskew Barcode Recognition AutoAnnotate Apply Stamp New Scan Process No Stamp Rescan Required

  16. Clinical Regulatory Quality Non-Clinical Publications Labeling Admin Queue Statistics DB Statistics Export Full Page OCR DCTM Export PDF Export New Scan Process Continued

  17. The New Form

  18. Patch Code Document Separation 2D Bar Code Human Readable Metadata The New Form Continued

  19. Value Assistance Processing Rules XML Export JSP Webform 2D Barcode Cover Sheet Technology Detail (Behind the Scenes)

  20. Web form values maintained in Repository Daily job exports data into XML file Dynamic Web Form Values Populated Technology Detail

  21. 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

  22. 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……

  23. Clarifications? Questions? Q&A Thoughts? Thank You!

  24. Tuesday Wednesday Thursday 6:00 pm – 7:00 pm 5:00 pm – 6:00 pm 8:00 am – 9:00 am Solutions Expo Hall – Level 1 Solutions Expo Hall – Level 1 South Pacific Ballroom – N. Conf. Center Presentations Will Be Available on the Momentum Las Vegas Website www.momentumlive.com Password: jackpot More Questions?Meet the Speakers Mixers

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