CASE STUDY

Supporting a Global Phase III Urticaria Trial with Clinion EDC, RTSM, and ePRO

Overview

A global Phase III urticaria trial required a centralized approach to manage blinded treatment assignment, patient-reported symptoms, and clinical data review across 600 patients and six sites.

The study included baseline randomization and a mid-study treatment transition, both of which had to be managed without breaking the blind. At the same time, patients reported symptoms from home through daily diaries and repeated weekly assessments for up to 42 weeks.

Clinion’s EDC, RTSM, and ePRO setup served as the trial’s digital execution layer. RTSM governed blinded allocation and mid-study transition rules, ePRO captured symptom data directly from patients, and EDC brought site data, safety records, and patient-reported outcomes into a review-ready environment.

Study Snapshot

Client & Industry

Industry

Biotech

Client

Biotech sponsor

Study Design

Study Type

Interventional

Therapeutic Area

Dermatology

Study Phase

Phase III

Randomization

Double blind

Study Design

Multi-country, blinded, multi-arm comparison study with a mid-study treatment transition and extended follow-up

Scale & Geography

Region

Global

Site Count

6 sites

Regulatory & Delivery

Submission

FDA-regulated drug product, per registry record

Products Provided

Clinion ePRO

Clinion EDC

Clinion RTSM

Study Duration

Approximately 16 months (As per registry record )

Challenges

Synchronizing RTSM Allocation, ePRO Diaries, and EDC Review Across Countries

The study had to keep blinded allocation, patient diaries, and clinical review aligned across 600 patients, six sites, and three countries.

Managing Two-Stage Randomization Without Breaking the Blind

Patients were randomized at baseline, with a second allocation step at mid-study. The challenge was keeping treatment logic and blinding intact at both points.

Sustaining High-Volume Patient Diary Completion

Patients reported symptoms from home through daily diaries and weekly assessments. The challenge was reducing missed entries and avoiding paper-based data collection.

Connecting ePRO Data with Site-Entered Clinical Review

Patient-reported symptoms had to stay linked with clinical, safety, and treatment data. The challenge was avoiding separate diary datasets and manual reconciliation.

Solutions

How Clinion Connected RTSM, ePRO, and EDC Into One Trial Workflow

Clinion configured EDC, RTSM, and ePRO as one connected trial workflow so the study team could manage allocation logic, patient-reported symptom data, and site-entered clinical data without treating them as separate workstreams. This was critical for a trial where endpoint quality depended on both patient diary continuity and blinded treatment control.

Clinion RTSM was configured as the allocation control layer for both baseline randomization and the Week 12 treatment transition. Instead of sites manually tracking which subjects continued or switched treatment at the midpoint, the RTSM workflow used each subject’s eligibility status, original assignment, treatment period, and protocol-defined transition rules to guide the next allocation step inside the system.

The workflow supported:

Baseline allocation across multiple blinded treatment groups
Week 12 re-randomization for eligible transition subjects
Dose-group continuity for subjects remaining on the same treatment path
Switch logic for subjects moving into the transition period
Eligibility validation before allocation and dosing events
Role-based access so blinded users only saw task-relevant information
Audit-traceable allocation history across both randomization events

This meant randomization, transition logic, and visit-based dosing did not have to be managed through manual trackers or site-level interpretation. RTSM helped preserve the blind, apply treatment rules consistently, and keep each subject’s allocation pathway traceable from baseline through the transition period.

Clinion ePRO gave patients a digital way to submit repeated symptom data directly from their own devices. This mattered because the trial depended heavily on daily and weekly patient-reported symptoms, and across 600 patients, daily diary capture over a study window of up to 42 weeks represented a very large, continuous volume of diary entries to manage.

The setup enabled:

Daily patient symptom entries without relying on paper diaries
Weekly symptom score data built from repeated daily inputs
Hives and wheal-related patient reporting over scheduled assessment windows
Angioedema-related symptom tracking during the treatment period
Quality-of-life questionnaire capture at defined study weeks
Missed diary visibility before gaps affected endpoint review
Patient-entered data capture across countries in one digital workflow

This meant ePRO was not just collecting patient responses. It helped keep repeated symptom data structured, timely, and easier to review across a 600-patient, multi-country trial.

Clinion ePRO was connected with Clinion EDC so patient-reported outcomes did not sit apart from the clinical record. Patient diary data, weekly symptom scores, and quality-of-life responses could be reviewed in context with site-entered visit data, treatment information, safety data, and study review workflows.

This helped the study team connect:

Patient diary entries with subject records
Weekly symptom scores with visit-level assessments
Quality-of-life responses with clinical data review
ePRO completion status with EDC review workflows
Patient-reported outcomes with safety and treatment context
Missing or incomplete diary data with query and follow-up actions

This meant reviewers did not have to manually reconcile patient diaries against the EDC dataset after the fact. ePRO and EDC integration helped keep patient-generated endpoint data connected to the broader clinical record throughout the study.

Clinion EDC gave the sponsor and CRO one review layer for the trial’s connected data streams: site-entered clinical data, safety data, immunogenicity records, and patient-reported outcomes from ePRO. Instead of reviewing symptom data separately from visit and safety records, reviewers could work from a subject-level structure where diary completion, clinical assessments, queries, and corrections stayed linked.

The configuration helped control:

Period-wise eCRFs for main treatment, transition, and follow-up data
ePRO-linked symptom data within the broader clinical record
Safety and immunogenicity review in the same EDC workflow
Custom review datasets for discrepancy and completion checks
Bulk query management for repeated data issues
Study reports for site completion and review readiness
Traceable corrections across the three-country site network

This gave the sponsor a more practical way to move from data capture to endpoint review, without relying on separate diary exports, manual reconciliation, or disconnected country-level trackers.

Outcomes

Core Results

Clinion’s connected EDC, RTSM, and ePRO workflow helped the sponsor and CRO reduce manual coordination, improve cost efficiency, and accelerate review readiness across a global Phase III trial.

Faster Treatment Transitions:

RTSM ran baseline and Week 12 randomization in one workflow, with less manual tracking.

Lower Patient Data Collection Effort:

ePRO captured symptom diaries directly from patients, no paper or transcription needed.

Accelerated Endpoint Review:

EDC linked outcomes, clinical data, safety records, and queries in one place, surfacing gaps earlier.

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