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!

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