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Klindat

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

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Overview

Klindat develops Electronic Data Capture (EDC) software designed for use in clinical trials and patient registries. The platform is web-based, requiring no local installations, and is accessible across multiple devices and browsers. Klindat serves a range of organisations involved in clinical research, including pharmaceutical companies, biotechnology firms, contract research organisations (CROs), research groups, hospitals, institutes, and non-profit organisations.

The platform is built around compliance with HIPAA, Good Clinical Practice (GCP), and 21 CFR Part 11 regulations. Data security is addressed through access control and SSL encryption, with daily backups and high service availability supporting reliability. Klindat offers customisation options including personalised logos, URLs, colour schemes, and data forms, alongside optimised workflows and close customer support.

Core Platform Capabilities

  • Web-based EDC accessible without software installation, compatible with multiple devices and browsers
  • Data management and reporting tools for studies of any size
  • Access control and SSL encryption for data security
  • Daily backups and high service availability
  • Compliance with HIPAA, GCP, and 21 CFR Part 11
  • Customisable forms, branding (logo, URL, colours), and workflows
  • Scalable architecture supporting both small and large studies

Pricing Structure

  • Pricing follows a two-part model: an initial setup fee based on the number of data forms required, plus a monthly subscription fee based on the number of enrolled patients
  • Initial setup tiers: Small EDC (7 forms) at $3,640; Medium EDC (15 forms) at $7,800; Large EDC (25 forms) at $13,000
  • Monthly subscription tiers: 1–19 patients at $600/month; 20–99 patients at $750/month; 100–299 patients at $900/month

Target Customers

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

Klindat operates with offices in the United States, United Kingdom, and European Union, and can be contacted directly for demo requests or pricing enquiries.