CASE STUDY

Electronic Data Capture for a Large Multi-Center Phase IV Cardiology Study

Overview

A clinical research organization (CRO) partnered with Clinion to support clinical data capture for a large, multi-center Phase IV cardiology study in diabetic patients with multi-vessel coronary artery disease. The CRO was managing the study across a wide national site network and needed a reliable, scalable way to collect clinical data consistently across every participating site.

The study was designed as a randomized, open-label, active-controlled trial using a 2×2 factorial model. The public study record describes the trial as comparing an ultra-thin strut sirolimus-eluting coronary stent against a standard everolimus-eluting stent, alongside an antiplatelet comparison and contemporary optimal medical therapy, in diabetic patients with multi-vessel disease, with target lesion failure at 12 months as the primary endpoint and longer-term follow-up beyond that. Running across roughly 90 sites with a target enrolment of around 1,800 patients, the study placed a premium on consistent, high-quality data capture at scale.

To support this, Clinion provided its validated EDC platform to enable structured, protocol-aligned data collection across the full site network. This gave the CRO and sponsor a single environment in which to capture, validate, and review clinical data as the study progressed.

Study Snapshot

Industry

Medical Devices / Interventional Cardiology

Client

Clinical research organization (CRO)

Study Type

Interventional

Therapeutic Area

Cardiology

Study Phase

Phase IV

Study Design

Randomized, open-label, active-controlled, multi-center (2×2 factorial)

Randomization

Open-label

Region

India

Site Count

Approximately 90 sites

Submission

DCGI (India)

Study Duration

18 months as per project input

Products Provided

Clinion EDC

Challenges

Capturing Consistent Clinical Data Across a Large, Multi-Site Cardiology Trial

The CRO needed to run a high-volume interventional study across a broad national site network while keeping clinical data consistent, complete, and review-ready. The scale of the trial, combined with a complex protocol and long follow-up, called for a data-capture approach that could hold up across many sites without adding operational drag.

Standardizing Data Capture Across a Large, Distributed Site Network

The public study record describes a multi-center trial running across approximately 90 sites spanning around 15 states, with a target enrolment of roughly 1,800 patients. Coordinating clinical data capture at this scale, across many investigators and care settings, made standardization difficult to maintain with paper or fragmented site-level tools. For the CRO, this created a need for a single, scalable EDC environment that could standardize data capture across every participating site.

Maintaining Data Quality for a Complex, Long-Follow-Up Protocol

The study was designed with a randomized, open-label, 2×2 factorial structure, with a primary endpoint assessed at 12 months and follow-up extending beyond that. A protocol of this complexity, captured across a large number of sites, increased the risk of missing, inconsistent, or out-of-range data entering the dataset. For the CRO, this created a need for built-in validation and centralized query management to support data quality throughout the study.

Supporting Traceable, Review-Ready Data for a Regulated Study

As a post-marketing study conducted under India’s regulatory framework and overseen by a large number of institutional ethics committees, the trial required structured, auditable data capture across its full visit and follow-up schedule. Manual or disconnected documentation could make oversight and review readiness harder to maintain at this scale. For the CRO and sponsor, this created a need for reliable data collection workflows that could support traceability, centralized monitoring, and review readiness.

Solutions

A Connected Clinion EDC Environment for Multi-Site, Review-Ready Data Capture

Clinion deployed its EDC platform to support clinical data capture for the study, helping standardize data collection across the full site network while supporting data quality and oversight. The configuration focused on keeping a large, distributed trial operating from one consistent data environment.

Clinion EDC was configured to support protocol-aligned data collection across the study's distributed site network. The platform enabled site teams to capture subject data, procedure information, and follow-up data in a consistent, structured digital environment, regardless of how many sites were entering data in parallel.

The EDC setup supported:

Study-specific electronic case report forms for consistent capture across all sites
Built-in, no-code edit checks and on-entry data validation
Protocol-aligned visit and follow-up workflows
A configurable query workflow with automatic and manual queries
A complete audit trail across user activity
Dataset extraction for review and analysis

By digitizing data capture across the site network, Clinion helped reduce dependence on manual documentation and supported cleaner, more consistent data collection.

Because data capture ran through a single EDC environment rather than disconnected site-level tools, the CRO and sponsor could work from one consistent view of study data. Instead of reconciling data from many separate sources, study teams could move from site entry through validation, query resolution, and review within one connected workflow.

This helped improve coordination across:

Site data entry
Edit-check validation
Query management and resolution
Centralized data review
Data consistency across sites
Export and review readiness

For a large, multi-site cardiology study, this unified data foundation helped reduce operational friction and supported tighter data oversight.

Outcomes

Core Results

Across this large, multi-site Phase IV cardiology study, the Clinion EDC platform supported improvements in data consistency, data quality, and study oversight for the CRO and sponsor.

Multi-Site Data Consistency

A single EDC environment helped standardize data capture across approximately 90 sites.

Data Quality

No-code edit checks and centralized query management helped support cleaner, more reliable data.

Oversight and Review Readiness

Structured, traceable capture with a complete audit trail supported centralized monitoring and review readiness.

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