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Professional Open Source for Clinical Research

OpenClinica Features

OpenClinica alleviates constraints and bottlenecks in clinical research by enabling you to:

  • Set-up studies quickly without requiring specialized technical expertise
  • Simplify study operations and improve data quality
  • Easily create and manage Case Report Forms (CRFs)
  • Centrally manage multi-site studies and system users
  • Organize research associates, coordinators, investigators, monitors, and sponsors
  • Safeguard Protected Health Information (PHI)
  • Maintain regulatory compliance
  • Customize features to precisely match the EDC requirements of each protocol
  • Dramatically lower study costs and cost per patient

Key System Features

  • Free, open source LGPL license
  • Web-based CRFs, study setup, and subject enrollment
  • Electronic Data Capture (EDC), data validation, and annotation
  • Tools for system oversight, auditing, configuration, and reporting
  • Unlimited sites, users, and protocols
  • Easy CRF design and versioning for re-use across studies
  • Double data-entry support, and reconciliation with built-in discrepancy/query management
  • Extensive interfaces for data query and retrieval across subjects, time points, and clinical parameters
  • Data output to common statistical analysis formats.
  • Compliance with HIPAA privacy and security guidelines
  • Data model based on CDISC standards for interoperability
  • Robust technology infrastructure based on Java J2EE
  • Database and operating system independent

For additional information about OpenClinica, including downloads, documentation, and support resources, see www.openclinica.org.