Next-Generation EDC

CDISC ODM 2.0 Compliant – Cloud-Ready – Future-Proof

A modern EDC platform for today’s clinical trials

Our Electronic Data Capture (EDC) solution has been fully redesigned to meet the evolving demands of clinical research: data standardization, regulatory compliance, scalability, and seamless integration with advanced analytics capabilities.

Built around CDISC ODM 2.0, our platform ensures full interoperability, traceability, and long-term sustainability of clinical data.

Native alignment with CDISC ODM 2.0

Our EDC natively implements the CDISC Operational Data Model (ODM) Version 2, covering both metadata and clinical data structures:

• Standardized study design

  • StudyEventDef, FormDef, ItemGroupDef, ItemDef

• Fully compliant clinical data model

  • ClinicalData, SubjectData, StudyEventData, ItemGroupData, ItemData

• Metadata and version management

• Support for ODM transactional model (Insert, Update, Remove)

• Comprehensive audit trail

 Benefits:

• Seamless interoperability with external systems (CROs, sponsors, regulators)

• Simplified downstream transformations (SDTM / ADaM)

• Reduced integration complexity

A scalable and cloud-ready architecture

Our platform is designed with modern architectural principles to ensure performance, scalability, and resilience:

• Modular, service-oriented architecture

• Real-time data processing capabilities

• Scalable data storage and processing layers

• High availability and fault tolerance

 Outcomes:

• Efficient handling of large, multi-center studies

• Flexible deployment across environments

• Long-term scalability without replatforming

Investigator-centric user experience

We provide a powerful and intuitive interface tailored for clinical users:

• Advanced form design capabilities with real-time preview

• Flexible CRF configuration

• Multilingual support

• Optimized workflows for site users

 Objective:

Reduce data entry burden and improve data quality at the source.

Built-in data quality and automation

Our EDC integrates advanced mechanisms to ensure data integrity:

• Configurable business rules and validation logic

• Real-time edit checks

• Automated query management

• Integration with external data sources (labs, devices, EHR systems)

Ready for advanced analytics and data-driven insights

Our architecture enables seamless integration with modern analytics ecosystems:

• Real-time data availability

• Structured data pipelines

• Compatibility with advanced analytics and machine learning environments

 Use cases:

• Early signal detection

• Risk-based monitoring

• Enhanced clinical decision-making

Regulatory compliance by design

Our platform is built to comply with international regulatory requirements:

• ICH E6(R2) / GCP

• 21 CFR Part 11

• EU Annex 11

• Full audit trail with timestamping

• Secure authentication and access control

• End-to-end data traceability

 Security features:

• Data encryption (in transit and at rest)

• Fine-grained access control

• Comprehensive logging and monitoring

Advanced study versioning and lifecycle management

• Full study version control

• Controlled promotion across environments (test → production → archived)

• Intelligent study duplication

• Protection of production configurations

Interoperability within the clinical ecosystem

Our EDC integrates seamlessly with:

• CTMS

• ePRO / eCOA platforms

• Randomization systems (RTSM/IRT)

• Supply and logistics systems

• Data warehouses and BI tools

A future-proof platform for clinical research

Our vision goes beyond data capture:

• Modular and extensible platform

• Support for complex and adaptive study designs

• Integration with workflow and process orchestration engines

• Real-time data utilization across the study lifecycle

Why choose our EDC?

•  Fully aligned with CDISC ODM 2.0

•  Scalable and cloud-ready architecture

•  Designed for interoperability

•  Regulatory compliance built-in

•  Modern and intuitive user experience

•  Future-ready and extensible