Paragon Solutions, Inc. Proprietary and Confidential

Practical Considerations for eTMF Planning Industry Webinar February 13, 2013 Fran Ross, Principal Consultant, Paragon Solutions

Michael Agard, Senior Consultant, Paragon Solutions

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Agenda

Introductions

Why the move to robust eTMF ?

People, process, technology requirements

Insight on eTMF maturity model

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Paragon Solutions’ Introduction

Corporate Facts • Privately owned,

30-year history • Professional Services

and Solutions Divisions • US-Based, NJ

Headquarters - 8 domestic and international offices - Overseas development center

• Dual-shore Delivery

Paragon is an enterprise information management solutions company that helps firms leverage information assets to achieve better business results.

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Practical Considerations for eTMF Planning

Does your electronic trial master file (eTMF) … …provide greater efficiency? …improve quality? …increase standardization? …enhance collaboration?

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What factors drive the move to a robust eTMF?

Practical Considerations for eTMF Planning

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eTMF Trial Enabler

TMF Paper to Electronic Evolution

• Paper based, localized TMFs

• Myriad interpretations of requirements

• Multiple copy / master record confusion

• Document “graveyard”

• No integration with master metadata

• Closed / locked environment

• Repetitive, error prone process

• Manual Retention & Litigation Holds

• Significant scramble for audit/inspection

• Centralized, global electronic TMFs

• Leverages TMF Reference Model

• Sole authoritative artifacts

• Active workflows to support study conduct

• Robust metadata for search and retrieval

• Open secure access

• Automated workflows support CT process

• Coordinated, automated RM processes

• Continuous readiness for audit/inspection

Paper TMF Repository

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Polling Question #1

Where are you on the eTMF continuum? a. No eTMF b. Electronic repository only c. Active eTMF, without full trial enablement d. Fully robust eTMF

eTMF status

28%

27% 19%

10% 3%

13% We currently use eTMF

Actively Building /Implementing

Evaluating

Actively Planning

Not Considering

Unknown/Not Applicable

What is the status of your organization's eTMF?

From TMF Reference Model working group

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eTMF Systems Evolution

9 Confidential – Proprietary to Paragon

Restricted Access

Balanced Document Access • Appropriate permissions, secure content • All sponsor, site, vendor and inspector roles

Scanned Documents

Electronic SmartDocs • Created, processed, filed electronically • Digital signatures, fillable forms • Prepopulated with applicable data

eTMFs on Separate Sys.

Seamless Technologies • Internal and partner eTMF in concert

e-Filing Cabinet

Knowledge Asset Tool • Workflows support CT processes (IP Release) • Smart alerts, actionable reports • Shares master CT data (CTMS, EDC, IRT) • Curated collection of email, NTF, correspondence

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Ready for a Truly Robust eTMF?

Robust eTMF is not a technology problem, it’s a people and process opportunity

Reliance on current process must be abandoned

• Paper is not required, ink signatures are not needed, document tracking tools are irrelevant

• Creators must be responsible for their content Perceptions of GCP “requirements” have to be challenged Both users and stakeholders buy into new business as usual

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Critical Factors When Embarking

Organizational readiness assessment: involve all players • Clinical, Ext team, Quality, IT, all others in trial landscape

Change Management communications from the start • Why will this change, WIIFM?

Clear-eyed view of the landscape • Critical programs, partnership/outsourcing, competitive programs, IT roadmaps

Thorough grasp of the Information Architecture • Clearly defined content (TMF RM) w/definitions and responsibilities

• Metadata, data flow, migration, integration

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Metadata is required for eTMF flow

Reduce keystrokes to create new study, country, site • Automate entry of trial personnel, roles and contact details

Enable user-friendly navigation and search Manage access and control by role, status or

content type Relate content collection to trial milestones Reduce process complexity of related documents

• Protocol amendments, informed consent Support in-flight Investigator changes

• Trigger collection of new CV, 1572, Financial Disclosure Automate signals for clinical trial process via workflows

• Investigational Product release

Robust eTMF flow critically relies on authoritative and accurate metadata

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Clinical System Interfaces

Project Planning CTMS

IxRS

Access Management

eTMF Submission Repository

Submission Publishing

EDC

Safety / PV

LMS / Training

Templates or Structured Authoring

Planning Study Conduct Reports / Submissions

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eTMF Navigation

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Polling Question #2

What is the biggest impediment to using CTMS data in eTMF? a. Data not collected early enough in the process b. Data quality and accuracy c. Lack of data warehouse or extraction abilities d. Lack of expertise for interface / integration e. Issues in sharing data between sponsor and CRO

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CTMS & TMF Data For Navigation

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CTMS & TMF Data in file names

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CTMS Search

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TMF Search Data

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eTMF Implementation Teams

Steering Committee

IT

Architecture & Environments

Migration & Decommissioning

Interface & Configuration Access & Security

Business

TMF Ref. Model / Index

Communication & Training Process

Study Implementation

Plan

Compliance, SOPs, Templates

Project Management

Yellow boxes are

key for initial

planning

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Additional factors / risk areas to address

People • Access management • Vendor Management / Consulting Services • Support services, HelpDesk, Technology Transfer

Process • Content flow for Regulatory Submissions • Electronic and digital signatures, workflows • Safety document management

Technology • CTMS Interface and data extraction and quality • Platform integration / Cloud services • Global performance

People

Process

Technology

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eTMF Maturity Model

Archive eTMF •Electronic archive of

TMF documents •Easier access for

business users •Standardized TMF

structure and management

•Centralized management and maintenance

•Well managed, AFTER document completes business process

•Minimal transition from paper to electronic documents

•Strong Scanning / Indexing reliance

Active eTMF •eTMF drives business

processes •Business users rely on

eTMF for all content needs

•Structure flexibility for trial requirements

• Improvements driven by central metrics

•Doc. mgmt . DURING business process (i.e., IP Release Authorization)

•Clin. Systems integration for consistent metadata

•E-workflow for internal review / approval

•Moderate transition from paper to e-docs

Integrated eTMF •Process and user

integration with site for full electronic submission / review

• Inspection readiness embedded in all eTMF user behaviors

•Process-driven trial milestone completion

•Full integration with internal systems

•All documents signed electronically (digital signatures), except legal/reg exceptions

•Transition from managing documents to managing data

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Our eTMF View

Robust eTMF allows organizations to: Reduce Clinical Trial process complexity Improve compliance by adapting or extending processes

and systems that ensure inspection readiness Have an authoritative source for trial documentation Increase authorized knowledge sharing Improve accuracy of research results Reduce records storage costs Determine efficient management and migration pathways for

TMF records Rely on eTMF as a clinical trial enabler

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Michael Agard, Senior Consultant, Paragon Solutions magard@consultparagon.com Fran Ross, Principal Consultant, Paragon Solutions fross@consultparagon.com Jeff Crawford, Director, Life Sciences, Paragon Solutions jcrawford@consultparagon.com Andy Lambros, Managing Director, Paragon Solutions, Europe alambros@consultparagon.co.uk

Visit our website at www.consultparagon.com

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