TrialAssure’s ANONYMIZE platform has been selected by the European Medicines Agency as an official anonymisation tool used within the Agency.
The platform will be used by EMA to redact clinical documents, including dossiers submitted by marketing authorisation holders, to help protect the identity and privacy of clinical trial participants.
The documents will be prepared for public release in line with EMA transparency initiatives, including its access to documents policy and wider clinical data publication work.
Clinical data transparency
EMA publishes clinical data submitted to support marketing authorisation applications after the regulatory decision-making process is complete. The Agency says clinical reports must be anonymised to prevent patients and professionals involved in trials from being identified.
Clinical data publication is intended to support transparency, build trust in regulatory decision-making and allow researchers to reassess clinical evidence.
TrialAssure said ANONYMIZE was selected following a structured vendor evaluation and market research process conducted by EMA in 2025.
“Anonymisation should be seen as a core capability that needs to scale, stand up to scrutiny, and support real transparency,” said Prasad M. Koppolu, chief operating officer at TrialAssure.
“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.”
AI-assisted anonymisation
TrialAssure ANONYMIZE is designed to support the secure handling of sensitive information across clinical documents, datasets and images.
The platform combines AI-assisted detection with expert oversight to help organisations protect patient privacy while maintaining the scientific utility of clinical information.
Such tools are becoming increasingly important as pharmaceutical companies, regulators and research organisations face growing expectations around clinical trial transparency, data protection and responsible data sharing.
EMA guidance on clinical data publication states that companies must anonymise clinical reports and provide an anonymisation report explaining their approach and its impact on data utility.
Regulatory data sharing
TrialAssure said the selection reflects demand for scalable anonymisation tools that can operate in real regulatory workflows and support auditability.
The company provides software and services for clinical trial disclosure, compliance tracking, AI-assisted content development and document and data anonymisation.
More information about the ANONYMIZE platform is available on TrialAssure’s website.
FAQs
What has EMA selected?
EMA has selected TrialAssure ANONYMIZE as an official anonymisation tool used within the Agency.
What will the platform be used for?
It will be used to redact clinical documents and help protect the identity and privacy of clinical trial participants before documents are made public.
Why does clinical data need anonymisation?
Anonymisation reduces the risk that patients or professionals involved in clinical trials can be identified from published documents or datasets.
How does TrialAssure ANONYMIZE work?
The platform combines AI-assisted detection with expert oversight to support anonymisation of clinical documents, datasets and images.
