Turning your eTMF into a Strategic Asset · 2013-11-14 · Turning your eTMF into a Strategic Asset Jennifer Goldsmith . ... dollars and drive significant lost revenue on the order

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Turning your eTMF into a

Strategic Asset

Jennifer Goldsmith

Page 2 // ©2013 Veeva Systems www.veeva.com

Sr. Consultant

Life Scieces 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


Documents play a significant role in study delays

Slow site initiation

Lengthy contracting and

budgeting processes

Gathering regulatory

documentation

Ethic committee review

and approval

Recruitment challenges

Contract and budget

negotiations

Receipt of regulatory

documents

Factors contributing to

study delays

Factors delaying first

patient enrolled

Sources: CenterWatch. June 2011

Drug Information Journal. 2011

Source: CenterWatch. June 2011


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.


“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


Data-driven site selection

Electronic document/workflows

Better visibility

Clearly integrated CRO/sponsor

process

What would reduce study initiation delays?

Source Benchmarking the study initiation process,

Therapeutic Innovation & Regulatory Science. 2013.


Roadmap: eTMF as a Strategic Asset

Get fully electronic

Define collaborative

processes

Build repeatable

framework

Use performance

metrics



Paper Electronic

Authoring

Processing

Archiving


Many firms store TMF artifacts electronically

Only

13% Are Fully Inspectable

Source: 2012 TMF Survey #2, Drug Information Association, November 2012.

50% 36%

27% 42%

7% 13%

16% 9% Unknown

Inspectable

paper

Inspectable

electronic

Combination –

paper & eTMF

2010 2012


Legacy of paper holds back productivity Im

pa

ct

Paper TMF Traditional eTMF New eTMF

• 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

• Workflows orchestrate

artifact collection

• Process metrics

available in real-time



processes


Identify roles and responsibilities

Document Subtype Classification Sponsor / CRO Functional Area Author

Trial Documents Investigator Brochure Sponsor Clinical Operations

Trial Documents Protocol Sponsor Clinical Operations Trial Manager

Trial Documents Protocol Amendment Sponsor Clinical Operations Trial Manager

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 Project Manager

General Meeting Material CRO Project Management Project Manager


Streamline processes to leverage technology


Streamline processes to leverage technology

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Systems

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How have you tried to improve

collaboration?


Build a repeatable

framework

Artifacts

Metadata

Roles

Milestones

Expectations


Systems


How has the TMF reference model

affected collaboration in your

organization?


Operationalize SOPs

Word based SOP Workflow based SOP


Shift work from people to the system


Use metrics to drive

performance


Monitoring plan availability

Monitoring report completion

Monitoring report reviewed

Monitoring follow-up letter completed

Metrics that help manage day to day operations


Metrics that drive inspection readiness

Source: Vault eTMF demo dashboard


Accuracy

Timeliness

Cycle time

Metrics that inform business decisions

Functional area

Therapeutic area

CRO

Investigator site

x


Systems


What metrics have you defined? How

do they help? Or how could they be

better structured to help?


Roadmap: eTMF as a strategic asset



processes

Build repeatable

framework

Use performance

metrics


How to get started – A case study

Maintaining readiness before the inspection

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See how Vault eTMF brings

sponsors, CROs, and sites

together in the cloud

veeva.com/etmf-demo


Systems

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