TrialAssure® – a leading, global software company advancing clinical trial disclosure and data transparency – has released its latest version of ANONYMIZE for Documents, including the functionality to anonymize and redact PDF documents concurrently. Leveraging the power of the cloud for processing, this software has been shown to save as much as 80 percent of the effort involved in the redaction and anonymization process for PDFs based on flexible and reusable rule setting features – as compared to traditional manual redaction.
TrialAssure ANONYMIZE for Documents is a first-in-class document redaction and anonymization software that combines machine learning – a form of artificial intelligence (AI) – and natural language processing (NLP) to protect patient privacy by automatically finding, masking, anonymizing, or removing personal or company confidential information from unstructured text. Through a streamlined, configurable rules-based approach, ANONYMIZE for Documents is able to quickly process documents, including:
- Clinical Study Reports (CSRs) and CSR amendments
- Clinical Study Protocols
- Statistical Analysis Plans (SAPs)
- Module 2-5 documents
- Patient Narratives
- Any other document formats including Adobe PDF and Microsoft Word
“We are seeing a dramatic increase in the need for clinical trial sponsors to complete new and retrospective anonymization of clinical documents,” said Kelly Vaillant, Director of Global Transparency Strategy & Compliance, TrialAssure. “The impetus for document anonymization comes as increasing regulations from global health authorities and added pressure from advocacy groups push for the expanded utility of data for secondary research.”
Machine learning makes document transparency easier
Through machine learning and AI, TrialAssure ANONYMIZE for Documents uses NLP to extract information whenever text is transformed, and the system then 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 unique user interface. In this most recent release, users are able to review, accept, and/or reject changes within the system. The system also auto-updates the rule set applied to the document based on reviewer feedback. This leads to greater efficiencies and data traceability.
“The future of clinical trials – especially as we move to a virtual or decentralized model – is dependent on the right technology to provide secure data sharing, while ensuring that the privacy of participants and company confidential information is respected,” said Mohamad Zahreddine, Chief Information Officer, TrialAssure, and member of the Forbes Technology Council. “We are on a mission to ensure that the entire industry can be transparent, allowing for increased trust and improved lives, and to do that, we must start with correctly anonymizing your documents and data.”
Pharmaceutical companies, universities, and clinical research organizations (CROs) that want to stay in front of global anonymization regulations, including European Medicines Agency (EMA) Policy 0070 and Health Canada Public Release of Clinical Information (PRCI), can request a demo of ANONYMIZE for Documents at www.trialassure.com.
TrialAssure is a leading, global clinical trial disclosure and data transparency software suite with unmatched experience in helping navigate complex regulatory compliance challenges. TrialAssure provides fast, affordable, and informed technology and service solutions to help clinical trial sponsors meet clinical trial registration and results reporting, document and data anonymization, patient engagement, and compliance reporting goals. Established in 2009, TrialAssure regularly adapts to ever-changing clinical trial disclosure and data transparency requirements and was recently named Data Solution of the Year—Healthcare in the Data Breakthrough Awards. For more information, visit: www.trialassure.com or follow TrialAssure on LinkedIn.