Designing a Connected Clinical Trial Document Ecosystem: Integrating CTMS (ViewPoint) and eTMF (Florence) to Reduce Operational Friction
Project Scope
Experience Design Consultant — Service Design, UX Research, and Workflow Optimization
Timeline: Q1 2025
Tools: Service Blueprinting, Journey Mapping, UX Co-Design Workshops, Stakeholder Interviews, API Workflow Optimization
Background
ViewPoint (VP) by Verily is a software solution used to streamline clinical trial sites workflows with an advanced clinical trial management system (CTMS). Florence is an electronic trial master file, used to store and organize regulatory clinical trial documents for running clinical trials.
The systems were integrated in Q1 of 2024 to ensure optimal user experience while conducting clinical trial within the Clinical Trial Program (CTP) at Kaiser Permanente.
The integration of the systems is part of The CTP’s digital ecosystem that incorporates several digital solutions to optimize the clinical trial experience at KP.
The Design Challenge
“How might we design a connected service ecosystem linking CTMS and eTMF systems to ensure compliant, efficient, and intuitive document workflows across clinical trial operations?”
The Numbers
The CTP has over 120 staff in the department of those 70 uses both ViewPoint and the Florence eBinder systems.
70+ staff managing high-volume regulatory documentation across multiple studies, where errors could directly impact audit readiness and compliance.
Research and Discovery
Research Goals:
-
Map end-to-end document lifecycle across systems
-
Identified handoffs between roles and platforms
-
Conduct mixed-method research (survey + interviews)
-
Synthesize insights into system-level breakdowns
Research Findings
PRE-LAUNCH
OVERALL SATISFACTION
Survey Results:
Sent to 110 CTP staff members, response rate of approximately 40% with 45 respondents.
Of the respondents the overall satisfaction rating was a 3 for neutral based on a five-point Likert scale addressing the questions above.
Qualitative Interview Post-Launch - Affinity Mapping
TASKS THEY STRUGGLE WITH
-
Uploading documents
-
Linking documents between Florence and Viewpoint
-
Navigating dashboard/menus
-
Finding study-specific documents quickly
-
Managing amendments or version control
PAIN POINTS / AREAS FOR IMPROVEMENT
-
Redundant data entry between systems
-
Confusion over user permissions/access levels
-
Lack of real-time syncing
-
Inadequate alert/notification system
-
Limited customization for site needs
-
Desire for mobile-friendly interface
FRUSTRATIONS
-
Feeling overwhelmed by too many clicks
-
Frustration when documents disappear or fail to save
-
Stress over poor customer support response times
-
Annoyance with inconsistent terminology across systems
-
Confusion about where to perform specific tasks
UNMET NEEDS
-
Need for better integration with other trial systems (e.g., CTMS)
-
Desire for automated reports / audit trails
-
Need for better training materials or in-app guidance
-
Interest in a more streamlined startup process
-
Request for cross-study search functionality
Outcomes
and Actions
-
Partnered with internal stakeholders and vendors to prioritize integration improvements based on user impact and compliance risk.
-
Contributed to prioritization of API synchronization and audit trail enhancements, reducing manual reconciliation efforts and improving confidence in document traceability.
Constraints and Lessons Learned
Survey Post Launch:
-
Unable to conduct survey post launch due to staff turnover and stakeholder decision to improve the technical experience and move towards training staff on regulatory compliance rather than improving software experience.
Qualitative Interviewing Sample Size:
-
Saturation is key the goal is to reach saturation, where you are no longer gaining new significant insights or themes from additional interviews.
-
More insights may have arisen from a sample size of 10-12