CASE STUDY

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

Overview

This was a global Phase III trial for a chronic skin condition, comparing an investigational treatment against an active comparator. The design had to stay blinded at two points: when patients were first assigned a treatment, and again mid-study, when some patients switched arms. On top of that, the trial depended heavily on how patients felt day to day, so they had to report symptoms continuously from home, not just what a site could see during a visit.

Both of these played out across a large group of patients. Across 600 patients, daily diary capture over a study window of up to 42 weeks created a complex, continuous stream of patient-reported entries, on top of weekly symptom scores, quality-of-life assessments, site-entered clinical data, safety data, and immunogenicity records. The trial depended on keeping three workflows synchronized: RTSM-driven allocation logic, ePRO-based symptom reporting, and EDC-based clinical review. A missed diary, a delayed symptom score, or a randomization transition handled outside the system could create operational noise across sites, patients, and blinded review teams.

Clinion brought EDC, RTSM, and ePRO into one connected workflow for the trial. RTSM managed baseline allocation and mid-study re-randomization logic, ePRO captured patient-reported symptom data directly from participants with reminder-based completion support, and EDC kept site-entered assessments, safety data, and patient outcomes aligned for review. For the sponsor and CRO, this reduced the risk of running randomization, patient diaries, and clinical data review as three disconnected workstreams.

Study Snapshot

Client & Industry

Biotech

Industry

Biotech sponsor

Client

Study Design

Interventional

Study Type

Dermatology

Therapeutic Area

Phase III

Study Phase

Double blind

Randomization

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

Study Design

Scale & Geography

Global

Region

6 sites

Site Count

Regulatory & Delivery

FDA-regulated drug product, per registry record

Submission

Clinion EDC

Clinion RTSM

Clinion ePRO

Products Provided

Approximately 16 months (As per registry record )

Study Duration

Challenges

Coordinating Blinded Allocation and Continuous Patient-Reported Data Across Countries

The study required more than standard site data capture. It combined multi-arm blinded allocation, a mid-study randomization event, repeated site-entered assessments, and continuous patient diary data across 600 patients. The sponsor needed every workflow to stay synchronized across six sites in three countries without breaking blinding or losing patient-reported data continuity.

Managing Two-Stage Randomization Without Breaking the Blind

Patients were assigned to blinded treatment groups at baseline, and eligible patients in selected groups required a second allocation step at the midpoint of treatment. The challenge was keeping treatment assignment, transition logic, eligibility validation, and blinding intact across both randomization events.

Sustaining High-Volume Patient Diary Completion

The study depended on daily patient-reported symptom data and repeated weekly outcome measures. Across 600 patients and up to 42 weeks, the daily diary burden alone represented a very large volume of possible entries. The challenge was keeping patients engaged, reducing missed diary entries, and avoiding paper-based transcription or delayed data entry.

Connecting ePRO Data with Site-Entered Clinical Review

Patient-reported itch, activity, hives, angioedema, and quality-of-life data had to remain usable alongside site-entered visit, safety, and treatment data. The challenge was preventing diary data from becoming a disconnected dataset that required manual reconciliation with the clinical record.

Solutions

Clinion EDC, RTSM, and ePRO for Synchronized Randomization, Patient Diaries, and Clinical Review

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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