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iTrials has been designed to comply with all federal privacy regulations and government requirements for protection of patient health data. Unlike many data products/services in today’s health care industry, iTrials has not been “re-worked” to comply – iTrials is designed to comply.
iTrials systems, methods, and practices have undergone exhaustive third party review by legal experts, statisticians, and numerous pharma industry compliance audits. In all cases, iTrials was shown to conform to all corporate and regulatory compliance standards, including:
HIPAA
iTrials fully supports the Health Insurance Portability and Accountability Act (HIPAA). iTrials maintains HIPAA compliant Business Associate agreements with the PPO, Clearinghouse, IPA and other healthcare organizations.
FDA
iTrials fully conforms to the FDA published document, Computerized Systems Used in Clinical Trials. This document details the acceptable functional parameters and behaviors of computer systems in a clinical trial process.
HHS OFFICE OF THE INSPECTOR GENERAL
iTrials also complies with the specifications for clinical trial web resources as defined in the OIG published document Clinical Trial Web Sites – A Promising Tool to Foster Informed Consent. This document presents recommended standards for resources used in clinical trials.
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