Category: Blog

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Modernizing Federal Technology for a More Connected and Efficient Government | TrialAssure

Modernizing Federal Technology for a More Connected and Efficient Government

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EMA Policy 0070, EMA’s New Transparency Rules: Don’t Be Caught Late or in Violation 

EMA’s New Transparency Rules: Don’t Be Caught Late or in Violation 

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GenAI to create Informed Consent Forms (ICFs)

How MMS and TrialAssure Engaged AI to Ethically Improve the Quality and Delivery in Producing Informed Consent Forms (ICFs) and other Regulatory Documents

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The following is a case study based on real work conducted between TrialAssure and one of its trusted sponsor partners. Problem  A clinical stage biotech company, sought to share their clinical trial datasets voluntarily with research partners for secondary analyses and derivative research. However, they faced significant challenges, including the high risk of re-identification due to a small patient population that makes traditional qualitative anonymization insufficient. Additionally, they needed to protect patient privacy while preserving the data's utility for meaningful research, as well as maintain compliance with varying global regulatory requirements.   To address these complexities, they sought an experienced partner capable of delivering quantitative, evidence-based anonymization.  Solution  TrialAssure, with its industry-leading AI-powered platform ANONYMIZE, was selected as the ideal partner to meet these challenges. Leveraging over a decade of experience in clinical data transparency and anonymization, TrialAssure delivered a comprehensive solution tailored to their needs, starting with a risk-based anonymization approach.  TrialAssure ANONYMIZE employed a sophisticated quantitative anonymization strategy to achieve measurable re-identification risk thresholds while maintaining optimal data utility. Through TrialAssure’s quick and efficient processes, the end-to-end project, encompassing risk analysis, anonymization, and reporting, was completed approximately 80 percent faster.   On top of the anonymized dataset, TrialAssure provided a detailed Data Anonymization Report and Data Specification Report to ensure visibility into the anonymization process, support informed decision-making, and demonstrate compliance with regulatory standards. Additionally, TrialAssure ANONYMIZE acted as a secure data exchange platform, enabling seamless and protected data sharing with the clinical-stage biotech’s research partners.

How a Clinical-Stage Biotech Accelerated Secure Clinical Trial Data Sharing 80% Faster with TrialAssure 

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Empowering Medical Writers: GenAI for Automated TLF Processing and Clinical Study Report Generation TrialAssure

New Webinar for Automated Clinical Study Report (CSR) Generation Announced!

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Empowering Medical Writers: Key Takeaways from TrialAssure's GenAI Webinar

Empowering Medical Writers: Key Takeaways from TrialAssure’s GenAI Webinar

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Generative AI Medical Writing Tool for the Pharmaceutical and Biotechnology Industries From TrialAssure Gets a Major Upgrade to Make Scientific Document Creation Easier

Generative AI Medical Writing Tool for the Pharmaceutical and Biotechnology Industries From TrialAssure Gets a Major Upgrade to Make Scientific Document Creation Easier

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New Generative AI in Medical Writing Webinar Announced!

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TrialAssure Wins Prestigious MichBusiness Triple Trusted Advisors Award for its Innovative AI Solutions

TrialAssure Wins Prestigious MichBusiness Triple Trusted Advisors Award for its Innovative AI Solutions

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Advancing Generative AI in Pharma from Ideation to Scaled Adoption: Viewpoints from the Pharma AI Summit in London

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