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EDC

Clinical trial data capture, validation, and reporting with drag-and-drop eCRF design and real-time monitoring dashboards.

Solution by Viedoc
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Overview

Viedoc EDC is an electronic data capture platform designed for clinical research teams, including sponsors and CROs, who need to build, launch, and manage clinical trials. It covers the full data lifecycle from study design and data collection through monitoring, reporting, and data lock, and is used across more than 7,500 global studies with over 1,200 trials currently active on the platform.

The platform is built around three core goals: accelerating study setup, reducing operational complexity across clinical trial systems, and maintaining continuous compliance and audit readiness. It has passed 100% of FDA inspections and is rated 4.5 out of 5 on G2 based on 263 reviews.

Study Design and Setup

  • Provides a visual, drag-and-drop designer (Viedoc Designer) for building eCRFs, edit checks, and workflows without coding.
  • Supports study launch in as little as 8 weeks through standardized forms and reusable templates.
  • Allows mid-study changes to be made instantly, without system downtime or vendor handoffs.
  • Centralized admin environment for configuring users, permissions, roles, and training.

Data Collection and Patient Engagement

  • Captures data securely at sites with real-time validation.
  • Supports decentralized clinical trial participation through Televisits, remote consent, and eSignatures.
  • Includes ePRO capabilities via Viedoc Me for patient-reported outcomes.
  • Web-based training reduces onboarding time and user error.

Monitoring, Reporting, and Compliance

  • Live dashboards provide real-time visibility into enrolment, queries, site performance, and data quality.
  • Automated validations, audit trails, and built-in reporting tools support custom report generation without external software.
  • Audit trail export available in PDF format.
  • Fully compliant with FDA 21 CFR Part 11, ICH-GCP, GDPR, HIPAA, and ISO 27001/SOC 2.
  • Supports SDV (source data verification), clinical review, data review, and sign workflows through a tabbed interface.

Integrations and Interoperability

  • Offers a REST API for connecting to existing clinical trial software including CTMS, EMRs, labs, and registries.
  • Exports data in CDISC-compliant formats.
  • Designed to eliminate the need for separate logins across EDC, CTMS, and patient engagement tools.

Licensing Options

  • Single Study Model: Covers one license with Viedoc EDC (Clinic, Admin, Designer), unlimited user access, support and maintenance, real-time data analytics, and customizable user roles. Add-on products are optional.
  • Multiple License Model: Provides unlimited licenses with all Single Study features plus volume-based discounts, predictable costs, tailored portfolio pricing, fixed rate cards, and flexible renewal options. Add-on products are accessible rather than optional.
  • Both models have no per-seat fees; pricing reflects actual usage.

Workflow Steps

  1. Design and configure: Build forms, logic, workflows, and reports in Viedoc Designer; set up users, permissions, and training in the admin environment.
  2. Collect and engage: Capture data at sites with real-time validation; support remote and decentralized participation via Televisits, remote consent, and eSignatures.
  3. Monitor, maintain, and export: Track study performance through dashboards, metrics, and custom analytics; generate reports and prepare for data lock.

Viedoc EDC is used by more than 500 clinical research teams worldwide. It supports both single-site and multinational studies, as demonstrated by case studies involving early phase trials, complex TB studies, migraine research, and Phase IIb investigations. The platform is delivered as a web-based system, reducing infrastructure requirements and supporting rapid adoption across sites and roles.

Meta

Domain
Clinical Trial Management
Subdomain
Electronic Data Capture (EDC)
Software type(s)
Workflow Automation
Deployment type(s)
Cloud / SaaS
Industry vertical(s)
Academic / ResearchBiotechCROPharma
Development stage(s)
Clinical
Target user(s)
Research ScientistQA / Regulatory AffairsClinical / Diagnostic ProfessionalIT / Systems Admin / Data Engineer
Compliance standard(s)
21 CFR Part 11GDPRHIPAAICHISO 27001SOC 2