TrialAssure’s ANONYMIZE platform has been selected by the European Medicines Agency (EMA) as its official clinical trial data anonymisation tool.
The EMA will use the Netherlands-based company’s system 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 0070.
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COO of TrialAssure, Prasad Koppolu, said: “We are proud to have been selected following the EMA’s evaluation process. 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.
On 15 April 2026, the European Data Protection Board (EDPB) adopted Guidelines 1/2026 on the processing of personal data for scientific research purposes, confirming that pseudonymised data remains personal data.
The guidelines represent the EDPB’s authoritative interpretation of how the General Data Protection Regulation (GDPR) applies to controllers and processors engaged in scientific research. It aims to provide clarity and practical guidance to a diverse and complex area of data processing, across all stakeholders, fields of research, data types, and technologies.
Privacy in US clinical trials is primarily governed by HIPAA, the Common Rule, and US Food and Drug Administration (FDA) regulations. These laws work together to protect patient information, manage consent, and oversee research ethics.
There are, however, geographical differences making this difficult for sponsors and biotechs to run global studies. The responsibility of ensuring compliance with any data protection laws sits with the sponsor. When sponsors are planning multi-country trials, they will want to collect the same data on every patient enrolled, but this may not be possible. As a result, this can make it difficult to conduct global trials, especially for biotech startups who may not fully grasp global laws.
As artificial intelligence (AI) becomes more deeply rooted in clinical trials, some concerns have been raised about patient privacy. This is something which regulatory bodies, such as the EMA and FDA, are stepping in to better regulate to ensure privacy is upheld when utilising these tools.
