Putting The Flow Into Workflows, While Staying Compliant With Regulations

The Regulations Involved In Global Clinical Trials Are Exceedingly Complex

The General Data Protection Regulation (GDPR) and the U.S. FDA’s 21 CFR Part 11 are only two of the regulations that clinical trial stakeholders must navigate. To prevent costly delays, fines, or even outright rejection, you need significant resources and effort to ensure compliance.

Judi Helps Clinical Trial Stakeholders With These Dilemmas

Through ongoing partnerships with clients and years of software development, AG Mednet built Judi with a keen eye for compliance including:

• Full compliance with 21 CFR Part 11, HIPAA, & GDPR
• Secure collection, transfer and storage of core data in any format
• Robust and compliant audit logging
• Enabled removal of protected health information (PHI) from document submissions.
• Control over who can see subject information

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