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 EDC gave all 15 sites the same CRF structure for capturing the study’s repeated screening, dosing, PK, safety, adverse event, and follow-up data. This was important because the same type of data had to be entered again across multiple treatment periods, and even small site-level differences could create repeated discrepancies across the dataset.

The setup helped standardize:

The 45 CRF page types used across the study
Period-wise dosing and treatment data entry
PK data capture within the correct subject and visit flow
Safety and adverse event documentation across repeated periods
Follow-up data entry across participating centers

This gave the sponsor and research partner one consistent data structure to review, instead of having 15 sites create variation across a high-volume, treatment-period-driven CRF dataset.

The most sensitive part of the study was PK data capture. Each treatment period required 18 defined PK sampling timepoints, so the eCRF structure had to guide site users to enter each sample against the correct period and timepoint.

Clinion EDC’s configurable eCRF builder helped align PK data capture to:

The 18 planned PK timepoints in each treatment period
The correct subject, visit, and period sequence
Dosing details linked to the corresponding PK collection window
Safety observations captured in the same period-wise workflow
Review fields needed for PK data checks and reconciliation

This helped reduce the risk of PK samples being entered in the wrong period, under the wrong visit, or without the supporting dosing and safety context needed for review.

With enrollment exceeding the original target, repeated discrepancies could appear across subjects, sites, and treatment periods. Clinion EDC’s bulk query management helped data managers handle recurring issues as study-wide patterns rather than isolated site-by-site follow-ups.

The workflow helped data managers:

Raise related queries for repeated data issues across affected records
Manage PK, dosing, safety, and AE discrepancies from one workflow
Track which sites had responded and which records still needed correction
Maintain correction history across subjects, visits, and periods
Keep review activity moving across the full 15-site dataset

This helped the team manage a larger-than-planned review workload without turning every repeated discrepancy into a separate manual follow-up chain.

Outcomes

Core Results

The use of Clinion EDC helped the sponsor and research partner manage a multicenter oncology comparator study with greater consistency, visibility, and data review control.

Review Efficiency

Edit checks and structured workflows helped identify data issues earlier, reducing late-stage cleanup effort.

Data Traceability

Centralized query and correction history helped maintain a clear audit trail from data entry through closeout.

Site Consistency

Standardized eCRFs and site-wise visibility helped 15 centers follow one consistent data capture process.

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