CASE STUDY

Improving Multi-Site Data Consistency for an Oncology Comparator Study with Clinion EDC

Overview

A 15-site oncology bioequivalence study in India required a structured digital approach to manage complex clinical data across multiple treatment periods, PK sampling schedules, safety assessments, adverse event tracking, and follow-up visits. The study involved patients with advanced ovarian cancer and metastatic breast cancer, making consistent data capture critical across every site, visit, subject record, and review workflow.

Clinion EDC was used as the central data capture platform for the study. It helped study teams configure protocol-aligned eCRFs, standardize data entry across participating centers, and give monitors and data managers centralized visibility into data completion, discrepancies, and query status.

By bringing multicenter data capture and review into one structured environment, Clinion EDC helped support cleaner data collection, stronger oversight, and a more traceable review process from first patient data entry through study closeout.

Study Snapshot

Industry

Pharmaceuticals

Client

Pharmaceutical sponsor

Study Type

Interventional

Therapeutic Area

Oncology

Study Phase

N/A (bioequivalence study, per registry record)

Study Design

Multicenter, open-label, randomized, replicate crossover bioequivalence (three treatment periods)

Randomization

Open-label (unblinded), computer-generated randomization per registry record

Region

India

Site Count

15 sites

Submission

India regulatory submission

Study Duration

Approximately 10 months, per registry record

Products Provided

Clinion EDC

Challenges

Maintaining Data Consistency Across a 15-Site Oncology Bioequivalence Study

This oncology bioequivalence study required multiple sites to capture PK, safety, treatment-period, and follow-up data with the same level of structure and consistency. The key challenge was maintaining data quality across distributed site teams while keeping central review workflows efficient.

Site-Level Variation in Data Entry

With 15 oncology sites participating across India, the study team needed consistent data capture across every subject, visit, and treatment period. Even small differences in how sites entered screening details, eligibility data, dosing records, safety assessments, or follow-up information could increase query volume, slow review, and create additional reconciliation work for the data management team.

Intensive PK Sampling Across Multiple Study Periods

The bioequivalence study involved a timepoint-heavy PK sampling schedule across multiple treatment periods, with 18 blood sample timepoints required in each period as per the registry record. This made accurate capture of sample timing, period-wise observations, and related clinical data critical. Missing, delayed, or inconsistent PK data entry could create downstream review challenges and affect the efficiency of bioequivalence data preparation.

Safety Monitoring and Central Data Review

The bioequivalence study required repeated safety assessments and adverse event monitoring across screening, treatment periods, and end-of-study follow-up. Safety monitoring was also listed as a secondary objective in the registry record. For the sponsor and study team, the challenge was to maintain centralized visibility into safety data, open discrepancies, and query status across all participating sites without depending on manual tracking or delayed site follow-ups.

Solutions

A Connected Clinion EDC Workflow for Multisite Oncology Data Capture

Clinion EDC was configured to bring site data capture, data review, and query management into one structured workflow for the 15-site oncology bioequivalence study. The platform helped study teams use protocol-aligned eCRFs, capture PK and safety data consistently, monitor site-level progress, and manage discrepancies from a central system through study closeout.

Clinion EDC supported the configuration of study-specific electronic case report forms (eCRFs) based on the study protocol and assessment schedule.

The eCRF design supported structured capture of:

Screening and eligibility data
Demographics and baseline characteristics
Oncology diagnosis and disease-related information
Treatment-period data
Dosing and infusion details
PK sample collection data
Safety assessments
Adverse events
End-of-study assessments

This helped ensure that site users followed a consistent data entry pathway and reduced the risk of variation across the 15 participating sites.

With Clinion EDC, all study sites entered data into a single digital environment. This helped the sponsor and research partner maintain centralized visibility across participating oncology centers.

The platform supported:

Standardized data entry across all sites
Centralized subject and visit-level data capture
Site-wise visibility into data completion
Easier identification of missing or incomplete records
Consistent review workflows across the study
Improved coordination between sites, monitors, and data managers

For a geographically distributed oncology study, this helped reduce dependence on manual tracking and scattered data review processes.

The study required repeated PK sampling and safety assessments across three treatment periods. Clinion EDC helped organize these protocol-defined requirements into structured forms and visit workflows.

The setup supported consistent capture of:

Pre-infusion PK data
Post-infusion PK timepoint data
Treatment-period observations
Dosing and comparator-related details
Safety assessment data
Adverse event records
Follow-up and end-of-study data

This helped the study team manage a data-heavy BA/BE/PK oncology study with better control and consistency.

Clinion EDC supported centralized data review and query management for the study. Data managers and monitors could review site-entered data, identify inconsistencies, raise queries, and track query closure within the platform.

The workflow helped support:

Discrepancy identification
Missing data review
Site clarification workflows
Query creation and tracking
Data correction traceability
Review status visibility
Cleaner closeout preparation

For a closed multicenter study, this helped support more organized review workflows and a stronger foundation for final data readiness.

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.

Data Consistency

Protocol-aligned eCRFs helped standardize clinical, PK, safety, and treatment-period data capture across 15 oncology sites.

Site Enablement

Structured EDC workflows helped site users capture complex study data more consistently across visits, periods, and assessments.

Sponsor and CRO Oversight

Centralized data visibility helped the sponsor and research partner monitor data completion, discrepancies, and query status across participating centers.

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