Best Practices for Vault eTMF Implementations › wp-content › uploads › 2014 › 10 › ... ·...
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Best Practices forVault eTMF ImplementationsMelissa Aron, R&D Practice Manager
®2014 Veeva Systems – Company Confidential veeva.com | 1
Safe Harbor
The following is intended to outline Veeva’s general product direction. It is intended for informational
purposes only and does not form part of any contract. It is not a commitment to deliver any specific
functionality and it should not be relied upon in making purchasing decisions. Features and functions
described in this document will be released commercially only when and if they become
available. The development, release, and timing of the features or functionality of Veeva’s products
remains at the sole discretion of Veeva.
®2014 Veeva Systems – Company Confidential veeva.com | 2
Today’s Session
Identify your starting point and goals
Examine effective resource allocations and timelines
Tips to stage deployment of features
Considerations on how to improve user adoption
®2014 Veeva Systems – Company Confidential veeva.com | 3
Where Are You on the Continuum?
Traditional
100% Paper
Central Processing Models Integrated Models
Paper during
execution &
in archival
®2014 Veeva Systems – Company Confidential veeva.com | 4
Where Are You on the Continuum?
Traditional
100% Paper
Paper during
conduct,
eArchive
Central Processing Models Integrated Models
Paper during
execution, scan
to electronic
after study close
Paper during
execution &
in archival
®2014 Veeva Systems – Company Confidential veeva.com | 5
Where Are You on the Continuum?
Traditional
100% Paper
Paper during
conduct,
eArchive
Active
Electronic
Repository
Central Processing Models Integrated Models
Paper during
execution &
in archival
Paper during
execution, scan
to electronic
after study close
Paper during
execution, scan
to electronic
while study is
active
®2014 Veeva Systems – Company Confidential veeva.com | 6
Where Are You on the Continuum?
Traditional
100% Paper
Paper during
conduct,
eArchive
Active
Electronic
Repository
Partially
Paperless
Central Processing Models Integrated Models
Paper during
execution &
in archival
Paper during
execution, scan
to electronic
after study close
Paper during
execution, scan
to electronic
while study is
active
Some % paperless
during execution,
scan any paper to
electronic while
study is active
®2014 Veeva Systems – Company Confidential veeva.com | 7
Where Are You on the Continuum?
Traditional
100% Paper
Fully
Paperless
Paper during
conduct,
eArchive
Active
Electronic
Repository
Partially
Paperless
Central Processing Models Integrated Models
Paper during
execution &
in archival
Paper during
execution, scan
to electronic
after study close
Paper during
execution, scan
to electronic
while study is
active
Some % paperless
during execution,
scan any paper to
electronic while
study is active
All TMF content
fully electronic
from study start
to archival
®2014 Veeva Systems – Company Confidential veeva.com | 8
Where Are You on the Continuum?
Traditional
100% Paper
Fully
Paperless
Paper during
conduct,
eArchive
Active
Electronic
Repository
Partially
Paperless
Paper during
execution &
in archival
Paper during
execution, scan
to electronic
after study close
Paper during
execution, scan
to electronic
while study is
active
Some % paperless
during execution,
scan any paper to
electronic while
study is active
All TMF content
fully electronic
from study start
to study
archival
Central Processing Models Integrated Models
®2014 Veeva Systems – Company Confidential veeva.com | 9
Set Project Goals: Short Term & Long Term
Who will use your system?
Your own clinical staff
External partners like a CRO (or for CROs, the sponsor)
Investigator sites
How will you use the system?
As an archive
As a collection tool
To draft, review and approve some information and collect other things
To share information with sites
To track study completeness
To monitor metrics
As an ISF
®2014 Veeva Systems – Company Confidential veeva.com | 10
Project Planning
Factors for timeline
Organizational size/volume of studies
The team — availability and background
Status of processes, document type model definition
Choosing the right people
Which Roles?
Engaged
Enthusiastic
Innovative
Available
Promote and demand participation
®2014 Veeva Systems – Company Confidential veeva.com | 11
Impacts of Your Document Type Model
Document
Type Model
Placeholders
&
TMF
Planning
BindersReporting
Migration
®2014 Veeva Systems – Company Confidential veeva.com | 12
“Where do I need to file this document?”
Many post-go-live support questions are
due to confusion regarding the new object
model
Proactively plan for document type
training
®2014 Veeva Systems – Company Confidential veeva.com | 13
Building out the Workflow and Lifecycle
Stay with the Basics
90% of typical scenarios addressed
by OOTB lifecycles and workflows
Go for low hanging fruit —
add extra processes later
Stay Flexible
Expect different trials, regions,
CROs to work differently
Don’t overcomplicate with “special rules”
Open Security where possible
“The system doesn’t work.
I can’t find what I’m looking for.”
®2014 Veeva Systems – Company Confidential
The way to get started is to quit talking and
begin doing.
Walt Disney
®2014 Veeva Systems – Company Confidential veeva.com | 15
Controlled and Calculated Ramp-up
UnblindedInformation
Basic Filing & Classification
Approval & eSign
User Onboarding
Audits & Inspections
Study/Country/ Site Initiation
Planning & Tracking
Lock, Closeout & Archival
Metrics & Reporting
IntegrationsFormat specific
processes Site Access
Relationships between docs
Document type specific processes
Document Type Model Definition
Many more…
®2014 Veeva Systems – Company Confidential veeva.com | 16
Improving User Adoption
Change management from selection onwards
Focused application training
Separate object model and process training, role based
Take advantage of Vault’s OOTB help materials
Focus your efforts on process related materials
Consider your external users when evaluating where to host
training materials
Open, regular forums for Q&A
®2014 Veeva Systems – Company Confidential veeva.com | 17
Roll on studies
HypercareSupport
Configuration Refinement
Training Delta
Deployment Plan
®2014 Veeva Systems – Company Confidential veeva.com | 18
Support Structure
Who will address business user questions?
Who will administer user accounts?
Who is the point person/team with Managed Services and
Vault Support?
Who will build new functionality into the system?
What is the process?
Who owns training?
®2014 Veeva Systems – Company Confidential veeva.com | 19
Keys to Success
Planning Scope Training Deployment
Understand your
starting point,
including people
and process
Set goals
Regularly assess
your goals
Build a solid
foundation
Slowly add more
pieces when
ready and as
needed
Fundamental
training
Phased approach
Role-based
Limit the initial
deployment
Feedback and
refinement
strategy
Support
structures and
processes in
place
Questions
Thank You
®2014 Veeva Systems – Company Confidential veeva.com | 22
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