CASE STUDY · HEALTHCARE
Clinical trial software for electronic data capture
RealCore is clinical trial software for electronic data capture, study configuration, and auditable reporting.
Industry
Clinical research
Client
RealworldEDC
Solution
Clinical trial data capture platform
Delivery
Approximately 1 year
See RealCore in action
Watch the video to see how RealCore supports clinical-trial workflows — from study configuration and form capture to patient participation, audit trails, and ODM-compatible data exchange.
01 — Context
Clinical research depends on reliable, traceable study data.
Clinical research laboratories need to configure studies, collect data from doctors and patients, preserve change history, and prepare results for reporting. Because clinical evidence must be trustworthy, the information captured during a study needs to remain structured, attributable, and available for review.
Many research workflows still combine paper forms, local spreadsheets, and separate systems. This makes it harder to maintain consistent study definitions, coordinate participant roles, and reproduce the same data structure across clinics.
02 — Problem
Paper-first clinical data collection limited traceability and repeatability.
RealworldEDC needed a solution for Japanese clinical research laboratories that could replace fragmented paper-first collection with controlled digital workflows. Research teams needed to set up studies, define forms and roles, collect doctor and patient input, and maintain a complete history of data and configuration changes.
Laboratories also needed to exchange trial definitions and data structures through ODM-compatible XML, while keeping each installation inside its controlled on-premise environment. The objective was to make clinical data capture, review, and reporting more consistent, traceable, and reusable across clinics.
03 — Solution
A clinical trial software platform for electronic data capture.
01. Study and clinic setup
Administrators and clinic managers configure clinics, studies, doctor accounts, roles, and permissions. This gives each research organization a structured starting point for running studies within its own operational environment.
02. Protocol forms and patient participation
Doctors enrol patients, complete protocol forms, record findings, and transcribe paper-collected information when needed. They can also generate secure links for forms that patients are required to complete.
03. Custom forms and study dashboards
Doctors can create custom forms and tag study information for trial-specific requirements. Dashboards make response rates, case conclusions, and clinic-level study activity easier to review.
04. ODM-compatible data exchange
Roles, permissions, study structures, and form definitions can be serialized to ODM XML and imported into another compatible environment, helping laboratories reuse consistent study configurations.
04 — Engineering
Built for controlled, auditable clinical research workflows.
RealCore is a server-rendered web application built with Spring Webflow and Java Spring services, supported by APIs for integration and data exchange. It was designed for on-premise deployment inside each research laboratory’s controlled infrastructure, with configurable roles and permissions across clinics, studies, forms, and patients.
ODM XML import and export, schema validation, record-level history, email notifications, and audit trails support the data integrity requirements of sensitive clinical research workflows.
On-premise, role-based access
Each laboratory can operate the platform inside its own controlled infrastructure and configure access boundaries by clinic, study, form, and user role.
ODM XML interoperability
Study metadata, configuration, and form definitions can be exchanged through ODM-compatible XML, with schema validation and version-aware handling of incoming data.
Audit trails and clinical data integrity
The platform preserves traceable history for configuration changes, data-entry updates, form submissions, and access actions, supporting reviewable clinical data workflows.
05 — Results
A clinical trial platform validated in real research settings.
RealCore was piloted across four clinics to validate study setup, structured form capture, patient participation, and ODM-aligned data workflows in clinical research environments.
Validated across four clinics
The platform was piloted across four clinics, validating its support for clinical-trial setup, data capture, patient participation, and structured study workflows.
Supported the next funding stage
The successful clinic pilots helped RealworldEDC secure its next financing round for continued product development.
Acquired by an EDC provider
RealworldEDC and the RealCore product were subsequently acquired by a Japanese company specializing in electronic data capture solutions.
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Frequently Asked Questions
What is RealCore?
RealCore is clinical trial software designed for structured electronic data capture in research laboratories. It supports study setup, form completion, patient participation, auditability, and ODM-compatible data exchange.
Which clinical-trial workflows does RealCore support?
RealCore supports clinic and study registration, role configuration, doctor account setup, patient enrolment, protocol forms, custom forms, patient-completed forms, dashboards, and clinic-level reporting.
How are doctors and patients involved in RealCore?
Doctors enrol patients, complete protocol forms, record findings, and create secure links for forms assigned to patients. Patients can access and submit only the forms explicitly assigned to them.
What is ODM XML used for in RealCore?
ODM XML is used to serialize and exchange study structures, roles, permissions, and form definitions between compatible research environments while preserving their structure.
How does RealCore support clinical data integrity?
RealCore uses configurable role-based access, record-level change history, schema validation, and audit trails for configuration, data-entry, form-submission, and access actions.