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LOUISVILLE.EDU
Improving Regulatory
Compliance with
Veeva SiteVault
Rachel Sheppard, MBA,CCRA,CCRC - Clinical Regulatory Director
Lale Akca,MBA,CCRA - Executive Director
LOUISVILLE.EDU
University of Louisville and Clinical Trials Unit
● Large, public institution
● Complex research environment
● ~40 staff members
● Three functional teams
● ~150 enrolling studies
● All disciplines
● Internally-designed CTMS
Bringing novel treatment options to patients in our community as fast as we can
LOUISVILLE.EDU
How I was Feeling…
LOUISVILLE.EDU
A Challenging Landscape
Long start-
up timeline
Multiple
campus
locations
Information
access
Inefficient
paper
process
Lack of
standardization
LOUISVILLE.EDU
Obstacles to Overcome
Lack of trust in
commercial system
Resistance to
new system
High
expectations
Limited
resources
Barriers
LOUISVILLE.EDU
• Paper reduction initiatives
• Folder structure on server
• DocuSign for signatures
• CTMS system
• Flash drives
A Band Aid Approach
LOUISVILLE.EDU
No More Paper
The operations team tried it all:
• Reviewing policies
• Scanning
• Shredding
• Boxing/unboxing
• Archiving
LOUISVILLE.EDU
eRegulatory Decision – Acceptance Criteria
Ease of use
Cloud-based platform
Process standardization
Autonomy
Increasing efficiencies
Attractive to sponsors
LOUISVILLE.EDU
Beyond
Storage
ReputationReporting CultureIntuitive
The Solution - Veeva SiteVault
LOUISVILLE.EDU
SiteVault Implementation
Considerations
Technology
acceptance
Time Training
and Roles
Financials Migration Policies IT
LOUISVILLE.EDU
Site Perspective on Implementation Challenges
Configuration
decisions
Security
constraints
New
terminology
Lack of
standardizationDedicated
time
Hybrid and
eRegulatory
system maintenance
The unknown
LOUISVILLE.EDU
SiteVault: Pleasant Surprises
1
2
3
4
5
6
Depth of support
Responsiveness
Trust building
Team experience
Solution focused, innovative thinking
Implementation timeline
LOUISVILLE.EDU
Optimistic about the Future
• Process standardization
• Cloud-based platform
• Autonomy
• Ease of use
• Increase efficiencies
• Reduction in monitoring time and costs
LOUISVILLE.EDU
THANK YOU
LOUISVILLE.EDU
QUESTIONS
For further queries, contact:
lale.akca@louisville.edu
rachel.sheppard@louisville.edu

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University of Louisville: Improving Compliance with SiteVault eRegulatory

Editor's Notes

  1. ~ 7,000 faculty and staff Clinical and research environment Existing hospital operating in Louisville Multiple research affiliations with local hospital systems Large affiliated physician practice Purchasing a healthcare system in Louisville (November 1st) World renowned researchers First hand transplant First artificial heart Kentucky Spinal Cord Injury Research Center
  2. We didn’t have a platform which would force them to do something in an order Faced lack of standardization in our organization We had been going through to become digital in many aspects Clinical function is not in same area as regulatory and finance – four different locations on campus. Not shared platform for all groups to have access to information
  3. Too expensive to develop our own CTMS capabilities for e-regulatory – our system not designed to do things like certify copies, signature, workflows Past experience with commercial systems where we didn’t have good experiences – we were serving the system rather than it serving our needs We had too many hurdles to do it ourselves Expectations were very high and this was a barrier to finding a new system we wanted to adopt Knew our staff would resist a new system too
  4. With the things we tried, we solved some problems, but created others. I.e: no chasing signatures, but cannot find the right docs Flash drive: saved paper/cost saving but still not as secure as we wanted, had limitations (no certification of docs, no sensitive information, no encryption) CTMS only allows us to post only the most current docs. No structure for a complex folder structure Monitors on site
  5. After one year of digitization, we started an unboxing initiative
  6. We had to create acceptance criteria for the solution if moving to eregulatory system
  7. - Culture – collaborative approach, speaking same language, felt supported from day one
  8. We had to make a lot of decisions while trying to gain deep understanding of how the system works.