TrialAssure’s newest addition to its transparency suite, ANONYMIZE for Documents, is intended for reports and documents, and it gives users the ability to apply rules that substitute information, reducing the possibility of a reader identifying a clinical trial patient. Using a powerful risk algorithm builder, ANONYMIZE for Documents generates a re-identification risk score and produces a risk assessment report, ensuring that the anonymized document meets an acceptable risk threshold.
“When clinical trial data and documents are released to the public or research community, they are often prepared through different channels and at different times – leading to inconsistencies in the anonymization process. These inconsistencies limit the value of the information, because they reduce the ability for other researchers to effectively analyze all the available data,” said Zach Weingarden, Product Solutions Manager, TrialAssure. “ANONYMIZE for Documents solves this problem by allowing users to apply the same techniques to all clinical trial outputs, taking a holistic approach that ensures both consistency and efficiency. Aligning with regulatory guidelines, it drives its effectiveness with sophisticated, modern technology – replacing the age-old manual redaction process.”
How it works
Through machine learning and AI, TrialAssure ANONYMIZE for Documents uses natural language processing to extract information whenever text is transformed, and feeds this data into powerful machine learning algorithms. In doing so, ANONYMIZE for Documents improves over time in identifying where and how text should be replaced. Before finalizing changes, users are encouraged to review all suggested anonymizations within its flagging system.
“The only efficient way for organizations to meet the upcoming anonymization regulations is to use the latest technology with machine learning and AI functionality that learns your company preferences in real time,” said Mohamad Zahreddine, Chief Information Officer of TrialAssure, and member of the Forbes Technology Council. “Major global health authorities are beginning to ask that clinical documents be anonymized. Using ANONYMIZE for Documents allows sponsors and researchers to meet these requests in a tech savvy, but budget-friendly, manner.”
Additionally, ANONYMIZE for Documents leverages rules and machine learning applied from TrialAssure’s data anonymization module, ANONYMIZE for Data, when both applications are implemented together.
ANONYMIZE for Documents is now available for limited release to pharmaceutical companies, universities, and clinical research organizations. Potential users that want to stay in front of global anonymization regulations can request a demo of ANONYMIZE for Documents at www.trialassure.com.
TrialAssure is a global clinical trial disclosure and transparency reporting suite with unmatched experience in helping clients navigate complex regulatory submission and reporting challenges. TrialAssure helps meet regulatory compliance goals through a flexible, scalable, and streamlined platform that regularly adapts to ever-changing clinical trial disclosure requirements. Established in 2009, TrialAssure was built from the ground up as a single, integrated transparency system, and it is continually strengthened by the experience of leading pharmaceutical industry compliance experts. For more information, visit: www.trialassure.com.
Don McLean, MBA