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EDC Solutions

Built to match your study. Not the other way round.

Most EDC systems model a trial as a matrix of forms tied to visits. When your protocol has complex arms, adaptive pathways, or conditional logic, the build team ends up engineering workarounds. Replior EDC inverts this. You start with the study design, and the data-collection layer is built to serve it.
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An EDC built by data managers, for data managers

Legacy EDC platforms were designed around forms and visits. Complex protocols — multi-arm designs, adaptive pathways, cross-over logic — have to be forced into structures that were never built for them. Build cycles stretch, amendments are painful, and data managers spend more time on workarounds than on data quality.

Replior EDC starts with the study design. Treatment arms, visit schedules, randomisation, and conditional logic are first-class concepts in the system, not hand-coded patches. Every screen is organised around how monitors, data managers, and biostatisticians actually work: by patient status, query priority, and data-review stage, not by CRF page number.
For over 25 years, clinical teams have trusted Replior for accurate, audit-ready data. Replior EDC is the system that brings that experience into a modern, AI-ready architecture.

Replior EDC

Here is what makes Replior EDC different from the systems your team has used before.

Study-First Design

Access Replior Virtual Visits directly from Replior EDC and eCOA/ePRO , or integrate with third-party systems.

Protect Patient Data

Meet ICH E6(R3), 21 CFR Part 11, and EU Annex 11 requirements with data protection measures validated through a risk-based framework.

Improve Team Efficiency

Screens are organised by patient status, query priority, and data-review stage. Your team works the way they think, not the way the system thinks.

Study-Specific Analytics

Progress and data quality are monitored against the protocol's actual reality, not a generic dashboard. Reports are customisable to your study's needs.

Maintain Accurate Data

Rely on automatic data saving and comprehensive audit trails.

Study Configuration and Trial Management

Replior EDC gives study teams full control over trial configuration, user access, and training, without requiring coding skills or IT involvement.

Role-Based Access

Portal-level and trial-level role-based access control. Define permissions for investigators, CRAs and monitors, sponsors, trial administrators, system administrators, assessors, coordinators, data managers, and medical coders.

Effortless eCRF Creation

Design and manage eCRFs with visibility logic, conditional skip and add rules, derived calculations, and amendment reporting. No programming skills required.

Visual Treatment-Arm Modelling

Treatment arms are modelled visually so every stakeholder can verify that the system matches the protocol before go-live. Complex multi-arm and adaptive designs are supported natively.

Role-Specific Training

Access to a trial is blocked until training and certification are complete. Role-specific training modules are delivered before system access is granted, and certificates serve as GCP training evidence for inspection.

Simple Trial Configuration

Configure trials with features such as edit check validators, skip/add logic, derived calculations, and more.

Freeze and Lock

Separate Freeze and Lock semantics at site, subject, and event levels. Clean audit trail coverage of both, meeting ICH E6(R3) requirements.

Flexible Data Collection

Replior EDC supports all data types collected from patient visits and imported from external sources, with native integration across the Replior platform.

3rd Party Integration

Integrates with third-party systems including S-Clinica, Suvoda and Veeva RTSM for seamless data exchange and trial interoperability.

File Import and Export

Import lab files, images, videos, and other binary files. Export data to SAS, ASCII, Excel, and PDF formats.

Edit Checks and Queries

Automatically trigger edit checks and enable CRAs, data managers, and medical coders to create and forward queries.

eCOA/ePRO Integration

Participant-reported data from Replior eCOA/ePRO flows natively into the clinical database. No reconciliation overhead, no integration tax. One system, one data record.

Stringent Data Security and Compliance

Replior EDC is validated through a risk-based framework and meets the highest standards of data security and regulatory compliance.

Regulatory Compliance

Compliant with ICH E6(R3) Good Clinical Practice, FDA 21 CFR Part 11, EU Annex 11, GDPR, and HIPAA.

Audit Trails

Immutable, exportable audit trails at both portal and trial levels, schema-compliant with ICH E6(R3) and 21 CFR Part 11. Comprehensive reports and exports support audit trail reviews.

Data security

All trial data is encrypted with AES-256, both in transit and at rest. Hourly backups ensure data integrity and availability, with operations certified under ISO 27001, ISO 14001, ISO 9001, and PCI DSS.

Meet Our EDC

See Replior EDC in action

Explore our demo library to see how the study-first design handles real-world protocol complexity.
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Related Products

eCOA/ePRO

Participant-reported data flows natively into Replior EDC. No reconciliation, no extra integration work.
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Device Provisioning

Device Provisioning — Pre-configured devices shipped to participants, ready to use with Replior eCOA/ePRO.
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Virtual Visits

Reach more participants by starting remote visits directly through the eCOA/ePRO app.
learn more

Digital Endpoints

ScratchSense and RaySense capture objective data no self-report instrument can replicate.
learn more

FAQ

Yes. Replior EDC is compliant with ICH E6(R3) Good Clinical Practice, FDA 21 CFR Part 11, EU Annex 11, GDPR, and HIPAA.
Yes. Replior EDC supports complex study designs through visual treatment-arm modelling, adaptive pathways, multi-arm protocols, and conditional logic. Configuration is handled through an intuitive builder, with no programming skills required.
Replior EDC maintains immutable, exportable audit trails at both portal and trial levels, from data entry through all changes. These are schema-compliant with ICH E6(R3) and 21 CFR Part 11, and support audit trail reviews with comprehensive reports and exports.
Replior EDC includes integrated role-specific training modules with training-gate enforcement. Users cannot access a trial until training and certification are complete. Certificates serve as GCP training evidence for inspection. A dedicated support team is available throughout your study.
Initial setup and qualification is completed within 10 days. Study configuration is typically ready for validation in 4 to 6 weeks, depending on protocol complexity.
Yes. Replior EDC integrates with other clinical trial systems and third-party applications. It also connects natively with Replior eCOA (ePRO) and the Stingray Observatory sensor backend.
Yes. Replior EDC supports all major web browsers and is fully responsive, working on desktops, laptops, tablets, and smartphones.
Yes. Study-specific configurations such as visits and eCRFs can be created in different languages to support global studies. The Replior EDC application interface is in English.
Replior EDC has APIs for data injection into CRF fields, and connects directly with the Stingray Observatory sensor backend, which processes data from ScratchSense, RaySense, and other Replior sensors. For broader wearable and eCOA (ePRO) data, Replior eCOA (ePRO) is the primary collection layer, with data flowing natively into the EDC.

Ready to see Replior EDC in action?

Book a Demo

Ready to see Replior EDC in action?

Book a Demo