EDC

Electronic data capture and clinical trial management for all study phases, with configurable eCRF design and integrated multi-source data harmonization.

Overview

ClinVigilant EDC is an electronic data capture platform designed for clinical trials across all phases (Phase I–IV). It provides a configurable environment for building and managing electronic Case Report Forms (eCRFs), either converted from paper CRFs or created directly using an integrated eCRF designer tool. The platform is intended for clinical research teams that need to manage study setup, data entry, and data integration across multiple sites and data sources.

The system is positioned as an integrated eClinical platform supporting clinical data management, with a focus on reducing study deployment time and improving data quality through built-in validation and workflow tools.

Key Capabilities

Fast Study Deployment: Includes site management, a CDASH-CDISC form template builder, user management, workflow scheduling, and permissions configuration. Over 90% of deployments are reported to be completed within four weeks.
Efficient Data Entry: Provides user-friendly data entry forms with direct input validation, edit checks, and auto-calculation formulas to support clean data capture and reduce database lock delays.
Integrated Data Management: Connects clinician, patient, and device data at an individual record level. Directly integrates eSource, eCRF, ePRO/COA, laboratory, and device data into a single system.

Platform Highlights

Supports Phase I through Phase IV studies
Multilingual eCRF support
CDASH-CDISC based global library
Medical coding tool
Dynamic workflow and patient scheduling configuration
Regulatory compliant

EDC Modules

Manage Sites: Multi-site management and site team management
Design Study: Workflow management, scheduling management, role access management, and rules and formula management
Data Entry: 360-degree view of subjects
Data Management: Query and deviation management
Integrations: Connectivity with external data sources and systems
Database Lock: Tools to support the database lock process

ClinVigilant EDC is built to support regulatory compliance requirements and is structured around CDASH-CDISC standards, making it applicable for global clinical trials. The platform covers the full data lifecycle from study design through database lock.