What  you  missed  at  the    3rd  Trial  Master  File  Summit  January  28-­‐29,  2014  -­‐  Alexandria,  VA  

   

www.exlevents.com/TMF  

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Why an eTMF Platform?

Disclaimer: Screen Shots of PTMF Contain Test Data and Do Not Reflect Actual Pfizer Clinical Trials

A dynamic solution to enable active contribution, organization, maintenance and monitoring of TMF documents

As part of the solution, Pfizer has built the necessary controls and measures to proactively manage quality in real time

Multiple Repositories – Paper and Electronic

Single, Centralized eTMF Repository

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Accountability and Compliance

Define TMF specification TMF Study Owner will develop and finalize study-specific TMF specification with relevant study team members and functional lines.

Create documents Document Owners creates and/or collect documents and verify that they are TMF-ready.

QC Documents TMF Document Specialists reviews and checks documents

Submit Documents Document Owners submit and index documents to the TMF.

Monitor Performance TMF Study Owners and Document Owners review and monitor TMF quality and compliance

The interaction across different roles A critical part in the success of the eTMF process

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3 4 5

“The act or process of using words, sounds, signs, or behaviors to express or exchange information or to express your ideas, thoughts, feelings, etc., to someone else”- Webster

WHAT IS COMMUNICATION?

Verbal Communication

Written Communication

Pictorial Communication

MANAGING COMMUNICATION GLOBALLY

What metadata information will be necessary for recovery, as well as reporting?

How will this information be stored?

How is this information shared?

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Technology*driven/clinical/trial/solu4ons/

eTMF

Site 1

Site 2

Site 3

Site 4

Site 5

Scanner&

File&Server&

eTMF&Admin&

Current Study Start Process Site&User&

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eTMF CONSIDERATIONS

•  SOP –  Sponsor Only

–  Combination Sponsor/Strategic Partner

–  Strategic Partner Processes

–  Is This Combination of Paper and eTMF System

•  TRAINING –  Who Provides Training

–  When/How Often Should Training Occur

–  How Training Occurs – Live/Video/Web

Strategic and Operations Objectives Operations functions tend to be focused on executing processes, but beneath those processes must lie a strategy aligned to the organizations objectives.

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x Focus  on  “Outcome”

x Goal  of  “Effective”

x “Do  the  Right Thing.”

x Focus  on  “Method”

x Goal  of  “Efficient”

x “Do  the  Thing Right.”

Strategic Objectives Operational Objectives

All Rights Reserved. The Views Expressed Are Those of the Presenter and May Not Represent the Opinions of Forest Research Institute, Inc.

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A  Varied  Technical  Landscape…

Central Paper Archives

Local / Functional Paper Archives

Doc. Management Systems

• Wet-Signature records • Print and submit electronic records • Verification and Filing • Reference Imaging

• May adhere to a centralized standard • De-centralized responsibilities • Available by request • Images not always available

• Electronic originals • Scanned copies • May be functionally-owned • Possibly not a true archive

In many organizations, Clinical Records – including the Trial Master File – reside in many locations and are stored within archives and systems of varied maturity.

5 All Rights Reserved. The Views Expressed Are Those of the Presenter and May Not Represent the Opinions of Forest Research Institute, Inc.

eTMF

eTMF Production •  Released in Summer 2012 •  Over 1,000 internal AZ

users •  Over 80 active studies

using eTMF solution

eTMF Near Future •  Externalizing access to:

•  CROs •  Investigators

•  Utilizing Exostar for external account management

eTMF Distant Future •  Possible move to the cloud

AstraZeneca Current Status

AstraZeneca eTMF

• How do you get this amount of new accounts created and given access to the system?

•  Is this just another account for an investigator to manage • Could be a huge process and cost to accomplish internally

AZ works with over 10,000 investigator sites year to year

•  Ensured our eTMF solution is SAML/ADFS compliant •  Partner with an external account management solution provider

What is AZ doing to handle this?

•  Allows Investigators to have a single account/credential to manage – access to multiple systems / multiple vendors

• Offload the technical and process infrastructure for provisioning and managing user accounts

•  Industry is moving in this direction (Transcelerate)

What is the benefit?

eTMF Externalization to Investigator Sites

®2014 Veeva Systems – Company Confidential veeva.com | 3

On average, a phase II / III study took

16.7 months from protocol approval to

100% approved sites initiated

Source Benchmarking the study initiation process, Therapeutic Innovation & Regulatory Science. 2013.

®2014 Veeva Systems – Company Confidential veeva.com | 8

Many Firms Store TMF Artifacts Electronically

50%$36%$

27%$42%$

7%$ 13%$16%$ 9%$ Unknown

Inspectable paper

Inspectable electronic

Combination – paper & eTMF

2010 2012

Only

13% Are Fully Inspectable

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Current Clinical Infrastructure

EDC SharePoint TMF/eTMF Safety Info

Standards

VPN Connections

CRO A CRO B CRO C CRO D

EDC-Related Systems

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TMF Preparation

•  All functional areas have access to documents in real-

time for review throughout the study in SharePoint •  Timing of CROs QC is critical to ensure all docs are

processed •  Need to be prepared for FDA inspection – must have all

documents ready in one place •  Monitoring reports reviewed timely to identify & address

trends/issues across studies/sites

TMF Reference Model – Do You?

Standard Contents Industry opinion on what

is kept in a TMF

Standard Naming Based on ICH E6 Sect. 8

& industry-accepted terminology

Standard Structure To support paper and

electronic systems

Standard Metadata For eTMFs, minimum

metadata at system and artifact level

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Merging+Cri*cal+TMF+Documents(

!  Quality%by%Design%con$nued(!  In<process(QC;(process(volume/FTE/FTE(type(!  Post(migra%on(QA(–(tracking(pockets(of(errors(and(frequency(!  Standardize(naming(conven%ons(!  User(upload(and(read(only(access((view(only(and(site(ac%va%on)(!  Scan((

"  In(Process(Scan(QC((pages,(orienta%on,(readability;(Adobe(1.4<1.7,(OCR(overlay;(300<600(dpi),(etc.((

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!  Technology(process(innova%ons(<(((example,(eCOPY((

Agenda

Introduction & Survey: WHERE are we?

The Components: What is a “Global Compliant TMF Records Management Archiving Platform” ?

Questions to Address while Creating the Platform

Why the Platform is Important

Creating the Platform

TMF Management

Adopt DIA TMF Reference Model (highly recommended)

Build general process workflows (SOPs, roles, responsibilities, timing expectations, etc.)

Develop detailed processes, tools, templates, and QC checks.

Assess Systems

Creating the Platform

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Key Considerations: Partnering with a CRO

!  Ability to tailor operations to trial phase, geography, TA, and function

!  Proper resourcing in response to changes in the portfolio

Flexibility

!  Lean staffing; staying within budget !  Compliant operations; low risk of delays in

filings

Operational Efficiency

!  Fit with Biogen Idec’s culture of data-driven research

!  Enables development of strategic capabilities

Strategic Fit