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Turning your eTMF into a
Strategic Asset
Jennifer Goldsmith
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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
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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
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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.
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“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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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.
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Roadmap: eTMF as a Strategic Asset
Get fully electronic
Define collaborative
processes
Build repeatable
framework
Use performance
metrics
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Get fully electronic
Paper Electronic
Authoring
Processing
Archiving
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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
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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
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Define collaborative
processes
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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
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Streamline processes to leverage technology
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Streamline processes to leverage technology
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www.veeva.com VEEVA CONFIDENTIAL
How have you tried to improve
collaboration?
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Build a repeatable
framework
Artifacts
Metadata
Roles
Milestones
Expectations
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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
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Monitoring plan availability
Monitoring report completion
Monitoring report reviewed
Monitoring follow-up letter completed
Metrics that help manage day to day operations
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Metrics that drive inspection readiness
Source: Vault eTMF demo dashboard
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Accuracy
Timeliness
Cycle time
Metrics that inform business decisions
Functional area
Therapeutic area
CRO
Investigator site
x
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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
Get fully electronic
Define collaborative
processes
Build repeatable
framework
Use performance
metrics
Page 26 // ©2013 Veeva Systems www.veeva.com
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
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