CASE STUDY

Clinion EDC for Managing Multisite Hospital Data in a Phase III COVID-19 Study

Overview

A biotech sponsor’s Phase III study set out to determine whether a COVID-19 treatment improved outcomes in hospitalized ARDS patients, across 20 sites in the United States and Canada. The study’s double-blind design meant that any anomaly in the data had to be resolved through review and query rather than by checking treatment assignment.

This made the data management more demanding than in most multisite trials: outcome data had to be captured accurately during hospitalization and then correctly linked to the same patients weeks later, often after discharge, while every safety event and mortality record needed to be reviewed to one consistent standard across all 20 sites.

Clinion EDC was deployed as the sponsor’s central data management system to meet these requirements. It standardized data capture across the site network, kept inpatient and follow-up data connected within a single subject record, and supported review, query management, and reporting throughout the study, while preserving the integrity of the blinded design.

Study Snapshot

Client & Industry

Industry

Biotech

Client

Biotech sponsor

Study Design

Study Type

Interventional

Therapeutic Area

Infectious Disease

Study Phase

Phase III

Randomization

Double blind

Study Design

Blinded, controlled hospital-based treatment study with structured follow-up

Scale & Geography

Region

United States and Canada

Site Count

20 hospital sites

Regulatory & Delivery

Submission

FDA-regulated drug product

Products Provided

Clinion EDC

Study Duration

Approximately 43 months, per project timeline (As per registry record and project input)

Challenges

Keeping Hospital Data Connected Across a Blinded, Multisite COVID-19 Study

The study’s data risk came from the movement of patients, records, and review responsibilities across a large blinded hospital network.

Standardizing Data Capture Across a Large, Multi-Country Site Network

Twenty sites across two countries had to capture clinical, treatment, severity, safety, and follow-up data consistently within the same EDC structure.

Maintaining Continuity of Outcome Data After Patient Discharge

Patients discharged before Day 28 or Day 60 still needed mortality and clinical improvement outcomes tracked within the same subject record.

Supporting Safety and Endpoint Review Within a Blinded Design

Safety events, mortality data, and endpoint-related records had to remain reviewable without disrupting the blinded study workflow.

Solutions

How Clinion EDC Structured Capture, Review, Queries, and Reporting Across 20 Sites

Clinion EDC created the structure needed to keep those moving parts connected, traceable, and ready for review.

Clinion EDC configured eCRFs around randomization stratified by site and baseline WHO COVID-19 severity, helping teams capture key trial variables consistently across patient records.

This helped the sponsor keep:

Screening, baseline severity, and treatment/infusion records structured as inpatient data
Day 28 and Day 60 assessments structured as connected follow-up records, not standalone forms
Protocol-driven field and criteria updates deployed uniformly across all 20 sites at once
Site-level data entry standardized regardless of hospital or country

Clinion EDC used study-specific edit checks to validate key safety and efficacy outcome fields as and when data was captured.

This helped data managers manage:

Missing Day 28 or Day 60 mortality status fields
SAE records lacking required onset or outcome data
Clinical improvement scores inconsistent with a patient's earlier assessments
Follow-up records left open past their expected window

Clinion EDC's query workflow let data managers raise, route, and resolve queries on safety and mortality records using only the data itself, with no need to reference treatment assignment at any point.

This helped the sponsor keep:

Safety and mortality queries resolved without unblinding
A full query and correction history attached to each subject record
Site response times and resolution status visible at the study level
Review activity continuous throughout the study, rather than concentrated around unblinding milestones

Clinion EDC's reporting views gave the sponsor one consolidated picture of site status.

This helped the sponsor track:

Data completion by site, regardless of U.S. or Canadian location
Open and resolved queries across the full network
Day 28 and Day 60 endpoint readiness at the individual site level
Sites falling behind the network's data-entry pace

Outcomes

Core Results

Clinion EDC gave the sponsor one controlled data environment for managing inpatient data, follow-up outcomes, safety review, and endpoint readiness across 20 sites.

Flexible eCRF Structure

Clinion EDC's eCRFs held inpatient and follow-up data as separate but connected structures, and rolled out protocol updates uniformly across all 20 sites.

Standardized Data Capture

All 20 sites captured data to the same standard, keeping records comparable across sites and across the U.S. and Canadian networks.

Safety and Data Integrity Maintained

Edit checks and a blinded query workflow caught inconsistencies as they arose, keeping safety and endpoint data accurate throughout the study.

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