University of Louisville: Improving Compliance with SiteVault eRegulatory
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The University of Louisville will share how using Veeva SiteVault for managing regulatory documents is improving visibility, compliance, and speeding clinical research operations. Learn more at https://sites.veeva.com/eregulatory-clinical-trials/.
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University of Louisville: Improving Compliance with SiteVault eRegulatory
- 1. LOUISVILLE.EDU Improving Regulatory Compliance with Veeva SiteVault Rachel Sheppard, MBA,CCRA,CCRC - Clinical Regulatory Director Lale Akca,MBA,CCRA - Executive Director
- 2. 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
- 3. LOUISVILLE.EDU How I was Feeling…
- 4. LOUISVILLE.EDU A Challenging Landscape Long start- up timeline Multiple campus locations Information access Inefficient paper process Lack of standardization
- 5. LOUISVILLE.EDU Obstacles to Overcome Lack of trust in commercial system Resistance to new system High expectations Limited resources Barriers
- 6. LOUISVILLE.EDU • Paper reduction initiatives • Folder structure on server • DocuSign for signatures • CTMS system • Flash drives A Band Aid Approach
- 7. LOUISVILLE.EDU No More Paper The operations team tried it all: • Reviewing policies • Scanning • Shredding • Boxing/unboxing • Archiving
- 8. LOUISVILLE.EDU eRegulatory Decision – Acceptance Criteria Ease of use Cloud-based platform Process standardization Autonomy Increasing efficiencies Attractive to sponsors
- 9. LOUISVILLE.EDU Beyond Storage ReputationReporting CultureIntuitive The Solution - Veeva SiteVault
- 10. LOUISVILLE.EDU SiteVault Implementation Considerations Technology acceptance Time Training and Roles Financials Migration Policies IT
- 11. LOUISVILLE.EDU Site Perspective on Implementation Challenges Configuration decisions Security constraints New terminology Lack of standardizationDedicated time Hybrid and eRegulatory system maintenance The unknown
- 12. 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
- 13. LOUISVILLE.EDU Optimistic about the Future • Process standardization • Cloud-based platform • Autonomy • Ease of use • Increase efficiencies • Reduction in monitoring time and costs
- 15. LOUISVILLE.EDU QUESTIONS For further queries, contact: lale.akca@louisville.edu rachel.sheppard@louisville.edu
Editor's Notes
- ~ 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
- 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
- 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
- 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
- After one year of digitization, we started an unboxing initiative
- We had to create acceptance criteria for the solution if moving to eregulatory system
- - Culture – collaborative approach, speaking same language, felt supported from day one
- We had to make a lot of decisions while trying to gain deep understanding of how the system works.