turning your etmf into a - veeva systems€¦ · turning your etmf into a strategic asset jennifer...

Turning Your eTMF into a Strategic Asset

Jennifer Goldsmith

Vice President, Veeva Vault

Veeva Systems

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Sr. Consultant

Life

Sciences

Practice

Leader

Global Manufacturing

IT

Life Sciences Practice Leader, Global Business

Services

Vice President, Veeva Vault

Jennifer Goldsmith Bio

Launched

Veeva Vault

Named to

PharmaVOICE

100

Named to

PABio Healthcare

Advisory IT Council

Clients include

Novartis, J&J, Par,

Medimmune

Clients include

Roche, BMS,

Pfizer, Pliva

Clients include

J&J, United

Technologies

1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013

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Documents Contribute to Study Delays

Study Delays First Patient

Enrollment Delays

Slow site initiation

Lengthy contracting and

budgeting processes

Gathering regulatory

documentation

Ethic committee review

and approval

Receipt of regulatory

documents

Contract and budget

negotiations

Recruitment challenges

Source: Tufts CSDD, Benchmarking the study initiation process, Therapeutic

Innovation & Regulatory Science. 2013.

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

On average, a phase II / III study took

from protocol approval to 100%

approved sites initiated

16.7 months

®2014 Veeva Systems – Company Confidential

A 12-month delay in product approval due to improper management of

clinical trial documents can increase development costs by 10’s of

millions of dollars and drive significant lost revenue on the order of $1-

2B dollars for a blockbuster product. …Significant redundancy and

rework in TMF management activities is unfortunately common (e.g.,

redundancies across geographies or between a sponsor and a CRO).

McKinsey Solutions, Trial Master File Management: Emerging

Trends and Best Practices

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How to Reduce Study Initiation Delays?

Clearly integrated CRO/ sponsor process

Better visibility

Electronic document workflows

Data-driven site selection

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Roadmap eTMF as a strategic asset

Define Collaborative

Processes

Transition to an eTMF

Application

Build Repeatable Framework

Use Performance

Metrics

1 3 4 2

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Transition to an eTMF Application

1

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Many Firms Maintain an eTMF

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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Paper Legacy Holds Back Productivity Im

pa

ct

Paper TMF eTMF Archive eTMF Application

Paper documents

Excel tracking spreadsheets

Electronic filing cabinet

Workflows reflect paper processes

Documents exchanged via email, FedEx, fax

No metrics or reporting

Repeatable framework

Multi-party collaboration

Work gets automated

Real-time metrics

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Paper Electronic

Generation

Monitoring

Archiving

Exchange

100%

Paper

100%

Paperless

TMF Continuum

Current

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Define Collaborative Processes

2

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Identify Roles and Responsibilities

Document Subtype Classification Sponsor / CRO Functional Area

Trial Documents Investigator Brochure Sponsor Clinical Operations

Trial Documents Protocol Sponsor Clinical Operations

Trial Documents Protocol Amendment Sponsor Clinical Operations

Trial Documents Sample Case Report Form CRO Data Management

Subject Documents Subject Diary CRO Data Management

Subject Documents Subject Questionnaire CRO Data Management

Reports Clinical Study Report CRO Statistics

Reports Pharmacokinetics Report CRO Statistics

General Relevant Communications Sponsor / CRO Project Management

General Meeting Material CRO Project Management

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Leverage Technology to Streamline Processes

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Leverage Technology to Streamline Processes

How have you tried to improve collaboration?

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Build a Repeatable Framework 3

Jen, I think this step is about a lot

more than the TMF Ref Model.

This is also about investing

upfront. E.g. It is a big pain to

create document placeholders for

everything, but by doing so, you

can now tell what is missing.

May be a hassle to create

workflows, but then the system do

the work for you.

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Define what’s needed to know what’s missing

How has the TMF reference model affected collaboration in your organization?

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Operationalize SOPs

Word based SOP Workflow based SOP

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Shift Work from People to the System

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Use Metrics to Drive Performance

4

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Metrics Driving Operational Excellence

Monitoring plan availability

Monitoring report

completion

Monitoring report reviewed

Monitoring follow-up letter

completed

TMF completeness by zone

TMF completeness by site

QC cycle time

QC rejection rate

QC findings

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Metrics Informing Business Decisions

Functional area

Therapeutic area

CRO

Investigator site

x Accuracy

Timeliness

Cycle time

What metrics have you defined? How do they help? Or how could they be better structured to help?

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Roadmap eTMF as a strategic asset

Define Collaborative

Processes

Transition to an eTMF

Application

Build Repeatable Framework

Use Performance

Metrics

1 3 4 2

How to Get Started — A Case Study

Maintaining readiness before the inspection

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Thank you

Jennifer Goldsmith

jennifer.goldsmith@veeva.com

484.588.4478