EDC

Capture, validate, and manage clinical safety data with integrated medical coding, real-time monitoring, and regulatory compliance for pharmacovigilance workflows.

Overview

Clinevo EDC/eCRF is a cloud-based, regulatory-compliant Electronic Data Capture and electronic Case Report Form system designed for pharmaceutical companies, CROs, and regulatory teams. It covers the full spectrum of clinical data management, from study planning and build through study conduct, discrepancy and query management, medical coding, and data extraction, within a single interactive platform.

The system is built to support drug safety and pharmacovigilance data management, with capabilities for case processing, compliance monitoring, and regulatory reporting. It is accessible via internet or intranet on standard browsers including Internet Explorer, Chrome, and Firefox, and is designed for rapid user adoption, with training achievable within a few hours.

Core Data Management Capabilities

Integrated medical coding with support for MedDRA and WHODD dictionaries, enabling clinical data coding directly within the platform.
Inbuilt Metadata (MDR) and Master Data Management (MDM) modules for managing study global libraries, sites, investigators, products, and other master data in a centralised repository, supporting reuse of information across multiple clinical trials.
Real-time monitoring through dashboards and reports for tracking study and site data, discrepancies, and queries.
End-to-end management of clinical data management activities including study planning, study build, study conduct, and data extraction.

Workflow and Automation Features

Configurable dynamic workflows designed to accommodate complex study requirements.
Integration with Clinevo Quality Management System (QMS) to manage CAPA, change control, deviations, audits, compliance documents, and training activities associated with clinical trials.
Actionable dashboards providing real-time visibility into study progress and data quality.

Compliance and Regulatory Readiness

Complies with 21 CFR Part 11, Annex 11, GxP, and GDPR regulations.
Includes automated compliance checks and robust audit trails.
Designed to remain aligned with current and emerging regulatory requirements.

Deployment and Support

Cloud-based deployment with committed infrastructure and hosting.
Transparent, optimised pricing model.
24/7 application support provided.
Dedicated support for implementation, training, and ongoing operational assistance.
Trusted by life sciences, pharmaceutical, biotech, and CRO clients across the USA, UK, Europe, Korea, Japan, China, and India.