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EDC

Electronic data capture for clinical trials and patient registries with HIPAA and 21 CFR Part 11 compliance.

Solution by Klindat
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Overview

Klindat EDC is an Electronic Data Capture software platform designed for clinical trials and patient registries. It is intended for a range of organisations including pharmaceutical companies, biotechs, contract research organisations (CROs), hospitals, research institutes, research groups, and non-profit entities.

The platform is web-based, requiring no local installation, and is accessible across multiple devices and browsers. Pricing follows a two-part structure: an initial setup fee based on the number of data forms required, followed by a monthly subscription fee scaled to the number of enrolled patients.

Key Features

  • Simple and intuitive interface: Designed to be clear and easy to use for clinical study teams.
  • Web-based access: No software installation required; accessible from any compatible browser.
  • Multi-device and multi-browser compatibility: Works across different hardware and browser environments.
  • Security: Includes access control and SSL encryption to protect study data.
  • Reliability: Daily backups and high service availability are provided.
  • Regulatory compliance: Meets HIPAA, Good Clinical Practice (GCP), and 21 CFR Part 11 requirements.
  • Data management and reporting: Includes tools for managing and reporting on clinical data.
  • Scalability: Supports studies of any size.
  • Customisation: Allows personalisation of logo, URL, colour scheme, and data forms.
  • Optimised workflows: Designed to support efficient clinical data collection processes.
  • Customer support: Offers tailored, close support to users.

Pricing Structure

  • Initial setup — Small EDC: 7 forms, $3,640
  • Initial setup — Medium EDC: 15 forms, $7,800
  • Initial setup — Large EDC: 25 forms, $13,000
  • Monthly subscription (1–19 patients): $600/month
  • Monthly subscription (20–99 patients): $750/month
  • Monthly subscription (100–299 patients): $900/month

Target Users

  • Pharmaceutical companies
  • Biotechnology companies
  • Contract Research Organisations (CROs)
  • Hospitals and research institutes
  • Academic and independent research groups
  • Non-profit organisations

Klindat EDC is available via a brochure download or demo request, with regional contact points in the US, UK, and EU. The billing model combines a one-time setup cost with an ongoing monthly subscription, providing a predictable cost structure for study sponsors and operators.

Meta

Domain
Clinical Trial Management
Subdomain
Electronic Data Capture (EDC)
Software type(s)
Record-Keeping System
Deployment type(s)
Cloud / SaaS
Industry vertical(s)
Academic / ResearchBiotechCROPharma
Development stage(s)
Clinical
Target user(s)
Research ScientistQA / Regulatory AffairsClinical / Diagnostic Professional
Compliance standard(s)
21 CFR Part 11GxPHIPAA