Clinical research technology

Clinical Research EDC, designed for the full data lifecycle

A specialized electronic data capture platform for studies that need structured eCRFs, subject and visit management, data review, controlled changes, auditability, reporting and reproducible exports.

The study data lifecycle

From eCRF design to study closeout

Our EDC platform is designed around the real study lifecycle: build the protocol structure, configure forms and visits, collect data, manage queries and validations, monitor quality, control changes and prepare analysis or publication-ready outputs.

Build → Capture → Review → Control → ExportA connected study workflow
01Study designProtocol structure, visits, forms and roles
02eCRF buildFields, logic, calculations and validations
03Data captureSubjects, visits, source-aligned entry and review
04Data reviewQueries, monitoring, signals and controlled changes
05Freeze & exportControlled datasets, provenance and repeatable outputs
Illustrative product architecture

One study workspace. Multiple operational views.

This visual is an illustrative interface concept created for the Swasthit website. It is not a screenshot of another EDC vendor and should not be interpreted as a live product screenshot.

Study setup eCRF & forms Subjects Visits Edit checks Queries Roles Audit trail Reports Exports
Study workspace · Illustrative view Configurable
DATA QUALITY

Study monitoring

Active sites12Configured
Subjects1,248Enrolled
Queries37Open
Signals12Review
Site data completion
Review queue

Missing data 14

Queries 37

Stable sites 8

Capability model

Eight layers of EDC maturity

Different studies need different levels of control and sophistication. The platform can be configured around the study's operational and governance requirements.

L1

Forms, subjects, visits and structured data entry provide the foundation for study data capture.

The platform supports study structure, subjects, visits, forms, field-level data capture and operational data entry workflows.

FormsSubjectsVisitsData entry
L2

Queries, validations, role-based access, reports and exports move the system beyond basic data entry.

Configure edit checks, data queries, role-based permissions, operational reports and controlled exports for routine study management.

QueriesEdit checksRBACReports & exports
L3

Audit trail, electronic signatures, validation and controlled changes support higher-governance study workflows.

Capabilities include traceable changes, user attribution, time-stamped audit information, electronic signatures and controlled configuration changes.

Audit trailE-signaturesValidationControlled changes
L4

Multi-study, multi-site, SSO, APIs and integrations support larger research operations.

Structure multiple studies and sites, integrate identity and external systems, and expose controlled APIs where required.

Multi-studyMulti-siteSSOAPIs & integrations
L5

Central monitoring, data-quality signals and risk dashboards help teams focus review effort.

Surface missing data, unusual patterns, query trends, site-level signals and configurable risk indicators for centralized review.

Central monitoringQuality signalsRisk indicatorsDashboards
L6

Dataset freezing, reproducibility, provenance and publication-oriented exports support the final data lifecycle.

Freeze controlled datasets, preserve metadata and provenance, document transformations and generate repeatable analysis or publication exports.

Dataset freezeProvenanceReproducibilityPublication exports
L7

CDISC/ODM, FHIR, APIs and standard terminology can connect the EDC ecosystem to other systems.

The architecture can support standards-based exchange and integration patterns; exact standard coverage depends on the implementation and project requirements.

CDISC / ODMFHIRAPIsTerminology
L8

AI-assisted review, anomaly detection and automated quality signals can augment data-management workflows.

AI can help prioritize records for review, identify unusual patterns and surface potential data-quality signals while keeping human review in the decision loop.

AI-assisted reviewAnomaly detectionQuality signalsHuman-in-the-loop
Governance & control

Built to make study data traceable and manageable.

Capabilities such as role-based access, audit trails, electronic signatures, validation rules and controlled changes can support controlled research workflows. Regulatory suitability depends on the configured system, validation evidence, procedures, infrastructure and intended use.

RBACRole-based permissions
Audit trailTraceable changes
ValidationConfigured edit checks
E-signatureControlled actions
Data freezeControlled datasets
ExportRepeatable outputs
Interoperability

Designed to connect with the wider data ecosystem.

Depending on the project, integration patterns can include APIs, structured data exchange and healthcare interoperability standards. Exact coverage is implementation-specific.

APICDISC / ODMFHIRStandard terminologyCSV / structured exports
Have a protocol or CRF?

Let's translate the study workflow into a digital system.

Share the protocol, CRF, workflow or data requirements. We can discuss the appropriate EDC, REDCap/eCRF or custom research technology approach.

Discuss an EDC Project