TrialAssure has announced that its ANONYMIZE platform has been selected by the European Medicines Agency (EMA) as an official anonymisation tool used within the Agency.
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EMA will use TrialAssure ANONYMIZE to redact clinical documents such as dossiers submitted by market authorisation holders to protect the identity and privacy of global clinical trial participants. Such documents will be posted to the public in accordance with transparency initiatives like EMA Policy 0043.
“We are proud to have been selected following the EMA’s evaluation process,” said Prasad M. Koppolu, chief operating officer, TrialAssure. “Anonymisation should be seen as a core capability that needs to scale, stand up to scrutiny, and support real transparency. It also has to work in real regulatory environments, be auditable, and preserve the value of the data. That is exactly what we have built, and we are proud to see that recognised at this level.”
TrialAssure ANONYMIZE is designed to support the secure handling of sensitive information across an expansive scope of documents, datasets, and images. The platform combines AI-assisted detection with expert oversight to help organisations protect patient privacy and maintain the scientific utility of the clinical data and information itself.
The selection follows a structured vendor evaluation and market research process conducted by EMA. TrialAssure participated in this process in 2025 as part of the Agency’s effort to identify scalable, compliant solutions capable of supporting the region’s increasing transparency and data protection requirements.
TrialAssure continues to support pharmaceutical companies, regulatory bodies, and research organisations around the world with solutions designed to meet growing expectations around transparency, compliance, and data protection.