Introduction
We built a deviation-prevention platform for clinical research sites — the operational layer that sits on top of fragmented sponsor systems, lab portals, and inboxes and gives coordinators, investigators, and site directors a single, trustworthy picture of every study. Instead of chasing protocol requirements across spreadsheets and email, teams see what is due, who is cleared to do it, and what needs attention before a deviation ever happens.
The objective was to turn the everyday reality of running clinical trial sites — delegation logs, training certifications, protocol schedules, and incoming lab results — into one calm, audit-ready workflow that meets HIPAA and 21 CFR Part 11 without slowing the people using it down.
- Compliance
- Part 11
- Audit
- 100%
HIPAA + 21 CFR Compliant
Every Action Logged
- Project Type
- Product Design & Development
- Target Users
- Coordinators, Investigators, Site Directors
- Tools Used
- Figma, FigJam, Linear
- Design System
- Custom UI Components
- Design Focus
- Clarity, Compliance, Accessibility
The Challenge
Clinical research coordinators miss protocol requirements not because they are careless, but because the information is scattered across sponsor EDCs, lab portals, and email inboxes. Legacy site tools are paper- and spreadsheet-bound — hard to navigate, easy to fall behind in, and never built to catch a deviation before it happens.
- Unifying data from EDCs, labs, and inboxes
- Tracking delegation and training by hand
- Standing up new protocols quickly and correctly
- Meeting HIPAA and 21 CFR Part 11 requirements
- Catching deviations before they occur
The Goal
Design a single operational source of truth that prevents deviations while staying audit-ready — rigorous enough for a regulated environment, yet as approachable as a modern consumer product.
- Surface deviations before they happen
- Enforce delegation and training gates
- Make protocol setup fast and reliable
- Stay audit-ready by construction
The Solution
The app brings the whole site operation into one dashboard. Coordinators open to a live picture of upcoming visits, lab alerts that need triage, and credentials about to expire — and every action is gated by who is personally delegated and currently trained to perform it.
Setting up a study is just as guided. A step-by-step protocol wizard turns a sponsor's Schedule of Assessments into a structured, versioned protocol — defining visit anchors, the visit schedule, and the procedures required at each visit — that then drives visit windows and deviation checks automatically.
Key Features
Delegation of Authority
Digital delegation logs with principal-investigator e-signatures. Only staff who are personally delegated for a procedure can perform it — enforced by the system, not by memory.
Training & Certification
Assign training requirements, track completion and expirations, and automatically gate study access the moment a certification lapses.
Protocol Setup Wizard
A guided, multi-step builder — anchors, visits, and procedures — with optional AI import from a Schedule of Assessments screenshot. Activated protocols are versioned and immutable.
Visit & Deviation Management
Visit windows are enforced straight from the protocol, and the patient pipeline is a live projection of visit progress — so nothing stalls unnoticed.
Lab Alert Triage
A background scanner reads incoming lab notifications, matches them to the right patient, and flags critical values for review — with clinical values kept out of the wrong places.
Design Approach & System
The interface is built for a regulated, data-dense environment: a calm, high-legibility palette and consistent data patterns — tables, status pills, and clear signature states — that reduce cognitive load for teams juggling multiple studies at once.
- Accessible by Default
- Legible typography, strong contrast, and unambiguous status semantics so critical state is never missed.
- Data-Dense Layouts
- Structured tables and status chips surface what matters at a glance, without overwhelming the screen.
UI Highlights
Operations Dashboard
Upcoming visits, lab alerts, and credential expirations in a single at-a-glance view.
Delegation Log Detail
Per-study staff duties with live PI and staff signature status.
Training Management
Requirement cards and staff-by-requirement views for assigning and tracking training.
Staff Directory
Roles, credentials, and site assignments for every member of the team.
Protocol Wizard
A guided, multi-step flow for standing up a new, versioned protocol.
Lab Alert Inbox
A triage worklist that routes lab notifications to the right patient.