Science 37 • 2022
Designing for Compliance: Building a Unified Workflow System for Decentralized Clinical Trials
HealthTech
Clinical Trials
Enterprise
SaaS
HIPAA
Permissioning
Multitenancy
Science37 was building clinical trial tooling feature by feature (adverse events, patient enrollment, medication logs, video visits), each scoped as its own product. I identified that nearly all of it was the same underlying interaction: structured data, routed to the right person at the right stage. I reframed the work around a unified forms system with role-based access and designed the end-to-end workflow for clinical coordinators and admins on desktop.
Science 37
Traditional brick-and-mortar research sites reach fewer than 10% of eligible clinical trial patients, leaving over 90% outside their catchment areas and often requiring long-distance travel to participate.
Science 37
Traditional brick-and-mortar research sites reach fewer than 10% of eligible clinical trial patients, leaving over 90% outside their catchment areas and often requiring long-distance travel to participate.
Science 37
Traditional brick-and-mortar research sites reach fewer than 10% of eligible clinical trial patients, leaving over 90% outside their catchment areas and often requiring long-distance travel to participate.
Overview
Designed a unified forms and workflow system for the clinical operations platform, covering multi-user permissioning, role-based access, eCOA (electronic clinical outcome assessments), video visits, and admin configuration. Contributed to and extended an existing design system.
Science37 needed a platform that could scale across multiple trial types and sponsor configurations without building bespoke tooling each time.
A unified forms system with configurable permissioning would reduce engineering overhead, accelerate trial setup, and support multi-tenancy -- meaning the same platform infrastructure could serve different sponsors and trials with different rules.
Compliance with HIPAA and FDA-adjacent regulations was non-negotiable and directly affected the viability of the product in market.
Overview
Designed a unified forms and workflow system for the clinical operations platform, covering multi-user permissioning, role-based access, eCOA (electronic clinical outcome assessments), video visits, and admin configuration. Contributed to and extended an existing design system.
Science37 needed a platform that could scale across multiple trial types and sponsor configurations without building bespoke tooling each time.
A unified forms system with configurable permissioning would reduce engineering overhead, accelerate trial setup, and support multi-tenancy -- meaning the same platform infrastructure could serve different sponsors and trials with different rules.
Compliance with HIPAA and FDA-adjacent regulations was non-negotiable and directly affected the viability of the product in market.
Overview
Designed a unified forms and workflow system for the clinical operations platform, covering multi-user permissioning, role-based access, eCOA (electronic clinical outcome assessments), video visits, and admin configuration. Contributed to and extended an existing design system.
Science37 needed a platform that could scale across multiple trial types and sponsor configurations without building bespoke tooling each time.
A unified forms system with configurable permissioning would reduce engineering overhead, accelerate trial setup, and support multi-tenancy -- meaning the same platform infrastructure could serve different sponsors and trials with different rules.
Compliance with HIPAA and FDA-adjacent regulations was non-negotiable and directly affected the viability of the product in market.
Want to see the designs?
User Needs
Clinical coordinators needed a consistent, reliable way to access the forms relevant to their role at each stage of a trial without hunting across a fragmented UI or encountering forms they weren't authorized to complete.
Admins needed to configure and manage those forms without engineering involvement.
Patients needed a clear, low-friction experience for their portion of data capture.
All users needed confidence that what they were doing was legally valid, the stakes of errors in clinical trial data are high.
User Needs
Clinical coordinators needed a consistent, reliable way to access the forms relevant to their role at each stage of a trial without hunting across a fragmented UI or encountering forms they weren't authorized to complete.
Admins needed to configure and manage those forms without engineering involvement.
Patients needed a clear, low-friction experience for their portion of data capture.
All users needed confidence that what they were doing was legally valid, the stakes of errors in clinical trial data are high.
User Needs
Clinical coordinators needed a consistent, reliable way to access the forms relevant to their role at each stage of a trial without hunting across a fragmented UI or encountering forms they weren't authorized to complete.
Admins needed to configure and manage those forms without engineering involvement.
Patients needed a clear, low-friction experience for their portion of data capture.
All users needed confidence that what they were doing was legally valid, the stakes of errors in clinical trial data are high.
Challenge
Clinical trial coordinators and admins were managing a fragmented set of tools -- each form type (adverse events, patient enrollment, medication administration, visit notes) was being designed and built in isolation as if it were a unique product. The underlying problem was the same in every case: capturing structured data from the right person at the right stage of a trial, with the right level of sign-off. Without a unifying framework, the platform was on track to become a collection of one-off features that would be expensive to maintain and hard to use.
The additional complexity: decentralized trials introduce a wide range of user roles -- coordinators, admins, sponsors, patients, nurses -- each with different levels of access, visibility, and authority. Getting that right wasn't a nice-to-have, it was legally required.
Challenge
Clinical trial coordinators and admins were managing a fragmented set of tools -- each form type (adverse events, patient enrollment, medication administration, visit notes) was being designed and built in isolation as if it were a unique product. The underlying problem was the same in every case: capturing structured data from the right person at the right stage of a trial, with the right level of sign-off. Without a unifying framework, the platform was on track to become a collection of one-off features that would be expensive to maintain and hard to use.
The additional complexity: decentralized trials introduce a wide range of user roles -- coordinators, admins, sponsors, patients, nurses -- each with different levels of access, visibility, and authority. Getting that right wasn't a nice-to-have, it was legally required.
Challenge
Clinical trial coordinators and admins were managing a fragmented set of tools -- each form type (adverse events, patient enrollment, medication administration, visit notes) was being designed and built in isolation as if it were a unique product. The underlying problem was the same in every case: capturing structured data from the right person at the right stage of a trial, with the right level of sign-off. Without a unifying framework, the platform was on track to become a collection of one-off features that would be expensive to maintain and hard to use.
The additional complexity: decentralized trials introduce a wide range of user roles -- coordinators, admins, sponsors, patients, nurses -- each with different levels of access, visibility, and authority. Getting that right wasn't a nice-to-have, it was legally required.
My Contributions
Identified that a fragmented feature roadmap was actually a single design problem: a forms system with configurable routing and permissions and successfully reframed the product strategy around that insight
Set the design direction and product logic for a multi-tenant permission model covering five distinct user roles
Served as the senior design voice in a cross-functional team where clinical and legal complexity was high and domain knowledge had to be built from scratch
Mentored a junior designer and guided their output, creating a collaborative dynamic where vision and execution were clearly divided and both were high quality
Earned strong alignment from PMs and clinical domain experts, a meaningful signal given how high the bar was for accuracy and compliance in this space
My Contributions
Identified that a fragmented feature roadmap was actually a single design problem: a forms system with configurable routing and permissions and successfully reframed the product strategy around that insight
Set the design direction and product logic for a multi-tenant permission model covering five distinct user roles
Served as the senior design voice in a cross-functional team where clinical and legal complexity was high and domain knowledge had to be built from scratch
Mentored a junior designer and guided their output, creating a collaborative dynamic where vision and execution were clearly divided and both were high quality
Earned strong alignment from PMs and clinical domain experts, a meaningful signal given how high the bar was for accuracy and compliance in this space
My Contributions
Identified that a fragmented feature roadmap was actually a single design problem: a forms system with configurable routing and permissions and successfully reframed the product strategy around that insight
Set the design direction and product logic for a multi-tenant permission model covering five distinct user roles
Served as the senior design voice in a cross-functional team where clinical and legal complexity was high and domain knowledge had to be built from scratch
Mentored a junior designer and guided their output, creating a collaborative dynamic where vision and execution were clearly divided and both were high quality
Earned strong alignment from PMs and clinical domain experts, a meaningful signal given how high the bar was for accuracy and compliance in this space
Constraints
HIPAA compliance
All data capture, routing, and access had to meet federal health data privacy requirements. This shaped every decision about who could see what and when.
Legal review cycles
Every feature went through legal review before release, which extended timelines and meant getting the logic right before handoff, not after.
Domain complexity
Clinical trial workflows involve regulatory requirements, medical procedures, and legal sign-off processes that most software teams and most designers don't come in knowing. There was a learning curve.
Multitenancy & Permissions
The system had to support different sponsor configurations, meaning the forms and permission logic needed to be flexible, not hardcoded. Roles & permissions dictate which forms and information a user can access which can become complicated when it comes down to specific form inputs.
Constraints
HIPAA compliance
All data capture, routing, and access had to meet federal health data privacy requirements. This shaped every decision about who could see what and when.
Legal review cycles
Every feature went through legal review before release, which extended timelines and meant getting the logic right before handoff, not after.
Domain complexity
Clinical trial workflows involve regulatory requirements, medical procedures, and legal sign-off processes that most software teams and most designers don't come in knowing. There was a learning curve.
Multitenancy & Permissions
The system had to support different sponsor configurations, meaning the forms and permission logic needed to be flexible, not hardcoded. Roles & permissions dictate which forms and information a user can access which can become complicated when it comes down to specific form inputs.
Constraints
HIPAA compliance
All data capture, routing, and access had to meet federal health data privacy requirements. This shaped every decision about who could see what and when.
Legal review cycles
Every feature went through legal review before release, which extended timelines and meant getting the logic right before handoff, not after.
Domain complexity
Clinical trial workflows involve regulatory requirements, medical procedures, and legal sign-off processes that most software teams and most designers don't come in knowing. There was a learning curve.
Multitenancy & Permissions
The system had to support different sponsor configurations, meaning the forms and permission logic needed to be flexible, not hardcoded. Roles & permissions dictate which forms and information a user can access which can become complicated when it comes down to specific form inputs.
Research
Domain knowledge was built primarily through two channels: the PM team, several of whom had direct experience running clinical trials and served as embedded subject matter experts, and a standing biweekly session with a small group of practicing clinicians who answered workflow questions, reviewed designs, and provided feedback in real time.
Research
Domain knowledge was built primarily through two channels: the PM team, several of whom had direct experience running clinical trials and served as embedded subject matter experts, and a standing biweekly session with a small group of practicing clinicians who answered workflow questions, reviewed designs, and provided feedback in real time.
Research
Domain knowledge was built primarily through two channels: the PM team, several of whom had direct experience running clinical trials and served as embedded subject matter experts, and a standing biweekly session with a small group of practicing clinicians who answered workflow questions, reviewed designs, and provided feedback in real time.
Process
Learn
Understanding how clinical trials actually run: the stages, roles, regulatory requirements, and how data moves between people before touching the interface
Reframe
Recognizing that adverse events, patient enrollment, medication logging, and visit notes were all variations of the same interaction: a structured form routed to the right person at the right stage
Define
Establishing a repository-based forms system where forms are configured once and surfaced dynamically based on user role, trial phase, and access level
Comply
Working through HIPAA requirements and legal review cycles to ensure every permission state, data handoff, and sign-off flow met regulatory standards before anything moved to engineering
Test
Bringing designs back to the biweekly clinician group to pressure-test complexity, language, and workflow sequencing
Process
Learn
Understanding how clinical trials actually run: the stages, roles, regulatory requirements, and how data moves between people before touching the interface
Reframe
Recognizing that adverse events, patient enrollment, medication logging, and visit notes were all variations of the same interaction: a structured form routed to the right person at the right stage
Define
Establishing a repository-based forms system where forms are configured once and surfaced dynamically based on user role, trial phase, and access level
Comply
Working through HIPAA requirements and legal review cycles to ensure every permission state, data handoff, and sign-off flow met regulatory standards before anything moved to engineering
Test
Bringing designs back to the biweekly clinician group to pressure-test complexity, language, and workflow sequencing
Process
Learn
Understanding how clinical trials actually run: the stages, roles, regulatory requirements, and how data moves between people before touching the interface
Reframe
Recognizing that adverse events, patient enrollment, medication logging, and visit notes were all variations of the same interaction: a structured form routed to the right person at the right stage
Define
Establishing a repository-based forms system where forms are configured once and surfaced dynamically based on user role, trial phase, and access level
Comply
Working through HIPAA requirements and legal review cycles to ensure every permission state, data handoff, and sign-off flow met regulatory standards before anything moved to engineering
Test
Bringing designs back to the biweekly clinician group to pressure-test complexity, language, and workflow sequencing
Early Sketches
While on calls with the other designer, I sketched some ideas for how I understood forms to explain how I thought everything could be simplified and all forms could be managed from one location
They Are All Forms
There are 3 major form types: Visits, Recurring, Logs
Make It Easier
One place to manage and view all trial forms
Early Sketches
While on calls with the other designer, I sketched some ideas for how I understood forms to explain how I thought everything could be simplified and all forms could be managed from one location
They Are All Forms
There are 3 major form types: Visits, Recurring, Logs
Make It Easier
One place to manage and view all trial forms
Early Sketches
While on calls with the other designer, I sketched some ideas for how I understood forms to explain how I thought everything could be simplified and all forms could be managed from one location
They Are All Forms
There are 3 major form types: Visits, Recurring, Logs
Make It Easier
One place to manage and view all trial forms
Pivot
The pivot was the project. I was handed a roadmap of disconnected features and asked to design them.
Once I understood what the platform actually needed to do, I made the case that we were building the same thing multiple times and we could simplify.
The redirect from "build these features" to "design a unified forms system" was something I drove, and the PMs and clinicians aligned with the new direction.
We expanded the design system to be responsive as clinicians and nurses sometimes had to make on-site visits to patients homes or sign up new patients from different locations.
See All Trial Forms
One place to access all major form types
Forms When You Need It
Accessible at relevant stages of a clinicians workflow
Responsive
For on-site visits
Pivot
The pivot was the project. I was handed a roadmap of disconnected features and asked to design them.
Once I understood what the platform actually needed to do, I made the case that we were building the same thing multiple times and we could simplify.
The redirect from "build these features" to "design a unified forms system" was something I drove, and the PMs and clinicians aligned with the new direction.
We expanded the design system to be responsive as clinicians and nurses sometimes had to make on-site visits to patients homes or sign up new patients from different locations.
See All Trial Forms
One place to access all major form types
Forms When You Need It
Accessible at relevant stages of a clinicians workflow
Responsive
For on-site visits
Pivot
The pivot was the project. I was handed a roadmap of disconnected features and asked to design them.
Once I understood what the platform actually needed to do, I made the case that we were building the same thing multiple times and we could simplify.
The redirect from "build these features" to "design a unified forms system" was something I drove, and the PMs and clinicians aligned with the new direction.
We expanded the design system to be responsive as clinicians and nurses sometimes had to make on-site visits to patients homes or sign up new patients from different locations.
See All Trial Forms
One place to access all major form types
Forms When You Need It
Accessible at relevant stages of a clinicians workflow
Responsive
For on-site visits
Workflows
Visit Forms (Clinician View)
Easy to Build Forms
Recurring Forms (Clinician View)
Log Forms (Clinician View)
View Log Details(Clinician View)
Video Visits & Forms (Clinician View)
Add New LAR (Legally Authorized Representative)
View Tenants(Admin View)
Managing Multitenancy(Admin View)
Workflows
Visit Forms (Clinician View)
Easy to Build Forms
Recurring Forms (Clinician View)
Log Forms (Clinician View)
View Log Details(Clinician View)
Video Visits & Forms (Clinician View)
Add New LAR (Legally Authorized Representative)
View Tenants(Admin View)
Managing Multitenancy(Admin View)
Workflows
Visit Forms (Clinician View)
Easy to Build Forms
Recurring Forms (Clinician View)
Log Forms (Clinician View)
View Log Details(Clinician View)
Video Visits & Forms (Clinician View)
Add New LAR (Legally Authorized Representative)
View Tenants(Admin View)
Managing Multitenancy(Admin View)
Learnings
Clinical and regulatory domains reward accuracy and patience over speed. Compliance with multiple roles and permissions is quite complicated and requires designing while considering they are all interconnected
Seeing the pattern across a fragmented roadmap is a skill I've developed. The instinct to ask "wait, aren't these all the same thing?" is something I'd bring earlier on future projects, and something I'd coach a junior designer to develop
Learnings
Clinical and regulatory domains reward accuracy and patience over speed. Compliance with multiple roles and permissions is quite complicated and requires designing while considering they are all interconnected
Seeing the pattern across a fragmented roadmap is a skill I've developed. The instinct to ask "wait, aren't these all the same thing?" is something I'd bring earlier on future projects, and something I'd coach a junior designer to develop
Learnings
Clinical and regulatory domains reward accuracy and patience over speed. Compliance with multiple roles and permissions is quite complicated and requires designing while considering they are all interconnected
Seeing the pattern across a fragmented roadmap is a skill I've developed. The instinct to ask "wait, aren't these all the same thing?" is something I'd bring earlier on future projects, and something I'd coach a junior designer to develop