CASE STUDY

Clinion EDC and RTSM for Managing a 1,800-Patient Phase IV Cardiology Study Across 12 Sites

Overview

A research sponsor ran a Phase IV cardiology study on long-term rheumatic heart disease treatment, enrolling 1,800 patients in a blinded study across 12 sites in India with follow-up extending up to two years.

The study was pragmatic in design, meaning sites continued routine-care treatment alongside the protocol, so the trial had to hold a controlled, blinded comparison steady while clinical practice varied by site.

Running allocation and clinical data through two separate systems, as is typical, would have meant syncing a patient’s randomization status with their clinical record by hand, over two years, across 1,800 patients. Clinion RTSM and EDC were deployed as one connected system instead, so allocation and clinical data stayed attached to the same patient record throughout.

Study Snapshot

Client & Industry

Industry

Research Institute

Client

Research sponsor

Study Design

Study Type

Interventional

Therapeutic Area

Cardiology

Study Phase

Phase IV

Randomization

Blinded treatment allocation

Study Design

Blinded comparative cardiology treatment study with long-term follow-up

Scale & Geography

Region

Multiple cardiology centers across India

Site Count

12 sites

Regulatory & Delivery

Submission

India regulatory context, per project input

Products Provided

Clinion EDC

Clinion RTSM

Study Duration

Long-term follow-up, up to 2 years per registry treatment plan (As per registry record and project input)

Challenges

Keeping RTSM Allocation and EDC Follow-Up Connected

With long-term follow-up across 12 sites, the sponsor needed allocation records, patient data, and follow-up activity to stay aligned as the study grew in volume and duration.

Designing and Maintaining eCRFs at Scale

The study included 1,800 patients across 12 sites, with follow-up continuing for up to two years. Clinion EDC helped keep eCRF data organized and consistent throughout the study.

Keeping RTSM Allocation Integrated With EDC Records

Treatment assignment and clinical data had to stay integrated without creating manual reconciliation work between randomization and data capture.

Maintaining Follow-Up Visibility Across Sites

With follow-up running across 12 sites for up to two years, the sponsor needed to see patient status, pending records, and site progress early enough to prevent gaps.

Solutions

An Integrated Clinion EDC and RTSM Workflow for Long-Term Cardiology Follow-Up

Clinion EDC and RTSM connected randomization, subject records, data review, queries, and reporting into one coordinated workflow.

Clinion EDC built eCRFs for this protocol's baseline and repeat follow-up visits, structured to stay manageable and consistent.

This gave the sponsor:

Reusable eCRFs kept follow-up data consistent without creating separate forms for every visit.
Built-in edit checks flagged missing or inconsistent fields during entry, reducing cleanup later.
Data patterns were easier to spot, helping teams identify recurring site-level issues early.

Clinion ran allocation and clinical data on a single connected platform, so a patient's randomization record and their EDC subject record were never separate data sets requiring manual reconciliation.

This gave the sponsor:

One subject record spanning randomization through every follow-up visit
Treatment assignment linked to the subject record under role-based access controls
No duplicate data entry was needed, helping sites save time and reduce manual work.

Clinion EDC's reporting views tracked follow-up status and site progress continuously, rather than only at scheduled study milestones.

This gave the sponsor:

Patient-level follow-up visibility to see which patients were falling behind on expected visits.
One platform to track follow-up trends across the two-year study period.
Early signals on site progress, showing where recruitment was complete and where sites were lagging.

Outcomes

Core Results

Clinion EDC and RTSM gave the sponsor a more reliable way to run a high-volume, long-term cardiology study across multiple sites.

Connected Trial Data

RTSM allocation and EDC subject records stayed linked, reducing reconciliation effort across 1,800 patients.

Scalable Data Capture

Reusable eCRFs, edit checks, and query workflows helped keep records consistent over two years.

Clearer Site Oversight

EDC reporting helped track patient follow-up, site progress, pending records, and review readiness across 12 sites.

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Clinion EDC and RTSM for Managing a 1,800-Patient Phase IV Cardiology Study Across 12 Sites

Study Snapshot

Challenges

Keeping RTSM Allocation and EDC Follow-Up Connected

Designing and Maintaining eCRFs at Scale

Keeping RTSM Allocation Integrated With EDC Records

Maintaining Follow-Up Visibility Across Sites

Solutions

An Integrated Clinion EDC and RTSM Workflow for Long-Term Cardiology Follow-Up

Study-Specific eCRFs Designed and Maintained at Scale

RTSM and EDC as One Integrated System

Follow-Up and Site Reporting Across a Two-Year Window

Outcomes

Core Results

Connected Trial Data

Scalable Data Capture

Clearer Site Oversight

Unlock the Future of Clinical Trials with Clinion.

Compliance

Fully Compliant with Global Standards