Intelligent Compliance: Transforming Clinical Trial Disclosure with AI

Last updated: Dec 4, 2025

By embracing AI strategically and ethically, the clinical research community can harness its power to drive efficiency, compliance, and patient centricity in clinical trial disclosure.

Executive summary

The clinical trial disclosure landscape is evolving rapidly, with increasing regulatory complexity, expanding disclosure requirements, and growing demands for transparency. This presents significant challenges for sponsors, who must navigate a complex web of global regulations and ensure trial information is disclosed accurately, consistently, and efficiently.

Artificial intelligence (AI) offers a transformative solution to these challenges. By automating tasks, improving accuracy, and enhancing transparency, AI can help sponsors streamline their clinical trial disclosure processes and meet the growing demands for timely and accessible information. These tools can also help with data extraction and organization, ensuring conformance to registry requirements, generating plain language summaries, and safeguarding sensitive data.

While AI presents significant potential, it’s necessary to approach its adoption responsibly. This involves addressing the associated challenges and mitigating risks related to data privacy, bias, and overreliance. Responsible AI adoption necessitates robust data protection measures, careful model training, and ongoing human oversight. By embracing AI strategically and ethically, the clinical research community can harness its power to drive efficiency, compliance, and patient centricity in clinical trial disclosure.

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