CASE STUDY

Capturing Longitudinal Real-World Data for a Multiple Myeloma Patient Registry with Clinion EDC

Overview

A pharmaceutical sponsor partnered with Clinion to support a prospective, observational patient registry for adults with multiple myeloma initiating a new treatment regimen. The public study record describes the registry as designed to capture real-world treatment patterns, healthcare resource utilization, and clinical outcomes, including patient-reported treatment response, across a 24-month target follow-up period per patient. Running an observational registry of this kind across 7 independently operating oncology centers meant capturing consistent baseline, treatment-pattern, and outcomes data without the structure of a fixed interventional visit schedule.

Clinion EDC was used as the central data capture platform for the registry. It helped the sponsor and site teams configure registry-specific eCRFs, standardize data entry across participating centers, and give the sponsor centralized visibility into patient-reported outcomes, data completion, and site-level progress across the registry’s full follow-up period.

Study Snapshot

Industry

Pharmaceuticals

Client

Pharmaceutical sponsor

Study Type

Observational (Patient Registry)

Therapeutic Area

Oncology

Study Phase

N/A (observational patient registry)

Study Design

Prospective, observational registry , non-probability sampling, 24-month target follow-up per patient

Randomization

Not applicable (non-interventional, observational registry)

Region

United States (multi-state)

Site Count

7 sites

Submission

US regulatory context, per project input

Study Duration

Approximately 28 months, per registry record

Products Provided

Clinion EDC

Challenges

Capturing Reliable Real-World Data Across a Multisite Oncology Registry

The registry required oncology sites to capture treatment patterns, baseline characteristics, patient-reported outcomes, healthcare resource utilization, and clinical outcomes over long-term follow-up. The challenge was maintaining data quality in a real-world setting where patient journeys, visit timing, and documentation practices could vary across sites.

Site-Level Variability in Real-World Data Capture

With seven oncology centers across five states, the registry needed consistent capture of baseline characteristics, prior treatment history, treatment patterns, and clinical outcomes. Since this was an observational study, differences in site documentation could create variability and make downstream analysis harder.

Sustaining Data Capture Across a 24-Month Follow-Up Period

The registry followed patients for up to 24-months, requiring ongoing capture of treatment response, healthcare utilization, and outcome data. Maintaining timely and complete records over this extended period was challenging without the fixed visit cadence of an interventional trial.

Centralized Visibility into Patient-Reported Outcomes

The primary outcome focused on patient-reported response to treatment over the follow-up period. The sponsor needed a centralized way to track PRO data, follow-up status, and related healthcare utilization across all seven sites without relying on manual site-by-site reconciliation.

Solutions

A Structured Clinion EDC Workflow for Multi-Site Registry Data Capture

Clinion EDC was configured to support consistent data capture and centralized review across the seven-site multiple myeloma registry. The platform helped the sponsor use registry-specific eCRFs, capture data consistently at each site, and maintain visibility into patient-reported outcomes throughout the registry’s follow-up period.

Clinion EDC supported the configuration of registry-specific eCRFs aligned to the registry's data collection plan.

The eCRF design supported structured capture of:

Baseline characteristics and prior treatment history
Treatment initiation and treatment-pattern data
Healthcare resource utilization
Patient-reported outcome (PRO) responses
Follow-up and long-term outcome data

This helped site teams capture longitudinal patient data in a consistent structure across the registry.

The registry included patient-reported treatment response as a key outcome over a 24-month follow-up period. It also required data on healthcare resource utilization and clinical outcomes.

Clinion EDC helped organize these data points into structured workflows, making it easier for sites to capture both clinical and patient-centered information in a traceable format.

The setup supported consistent capture of:

Patient-reported outcome questionnaire data
Treatment response information
Healthcare utilization data
Clinical outcome data
Follow-up status and longitudinal updates

This helped the study team manage a broader real-world evidence dataset within one system.

Clinion EDC gave the sponsor and study team centralized visibility into registry data across all participating sites.

Data managers and reviewers could track subject-level completion, identify missing or inconsistent fields, raise queries, and monitor resolution within the platform. This helped reduce dependence on manual follow-ups and supported more organized registry data review.

The workflow helped support:

Site-wise data completion tracking
Missing data identification
Query creation and resolution
Data correction traceability
Follow-up status visibility
Cleaner registry closeout preparation

For a real-world, multi-state patient registry, this helped reduce the operational friction of coordinating data collection across independently operating sites.

Outcomes

Core Results

Clinion EDC helped the sponsor manage the registry with stronger consistency, centralized visibility, and better control over longitudinal data.

Real-World Data Standardization

Registry-specific eCRFs helped sites capture patient, treatment, PRO, and outcomes data in a consistent format.

Simplified Multisite Coordination

Seven oncology sites worked within one shared EDC environment, reducing fragmented tracking across locations.

Centralized Outcomes Visibility

The sponsor could monitor PRO, follow-up status, treatment history, and resource utilization data centrally.

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