Artificial intelligence (AI) and machine learning (ML) herald a new era of regulatory operations in clinical trials. These advanced technologies are revolutionizing how companies manage regulatory data, predict outcomes, and ensure compliance, ultimately leading to greater efficiency and accuracy.
From the IQVIA article published on its website on June 10, 2024, we would like to highlight one of the most significant benefits of AI and ML: Their ability to handle large amounts of regulatory data efficiently in clinical studies. These technologies facilitate more efficient regulatory reporting and compliance monitoring by streamlining data collection, organization, and analysis. (1)
Regulatory Processes in Clinical Trials: Why implement AI and ML?
- Enhanced Data Management: AI and ML facilitate the handling of large volumes of data generated during clinical trials. These automate data collection, organization, and analysis, ensuring that data is accurately processed and readily available for regulatory submissions.
- Improved Predictive Analytics: AI and ML can predict potential outcomes and identify risks in clinical trials. By analyzing historical and real-time data, these technologies help forecast trial success rates, patient responses, and regulatory approval chances, enabling better decision-making and risk management.
- Automation of Repetitive Tasks: AI-driven automation reduces the burden of manual, repetitive tasks such as data entry, document review, and compliance checks.
- Regulatory Intelligence and Compliance: AI systems continuously monitor global regulatory updates and changes, providing real-time insights into new requirements and guidelines. This helps ensure that clinical trials remain compliant with the latest regulations, avoiding potential delays or penalties. (2)
In addition, AI and ML’s predictive capabilities allow biopharma companies to anticipate regulatory outcomes and potential risks in clinical trials, enabling informed decisions and proactive mitigation of issues. Another area where AI excels is automating routine tasks, such as data entry and document management.
This automation increases productivity and minimizes human error, allowing regulatory professionals to focus on strategic activities.
Moreover, AI-based regulatory intelligence systems continually monitor and analyze global regulatory updates, providing information that can be used to improve the efficiency of the regulatory process. At Integra It, we are implementing generative AI in all the informed consent sections of our TrialPal eCOA ePRO Solution. This AI generates images and/or videos from the consent form texts complementing each section.
Our development experts are working on incorporating 100% artificial intelligence to predict erroneous data, patients’ actions and trends, facilitating decision-making.
We encourage you to keep updated with our communications and be the first to try this new tech in your clinical trials. Subscribe to our newsletter.
References:
(1) IQVIA. (2024, junio). Harnessing AI and ML: A new era in biopharma regulatory operations. IQVIA. https://www.iqvia.com/blogs/2024/06/harnessing-ai-and-ml-a-new-era-in-biopharma-regulatory-operations
(2)Thomson Reuters. (2019, January 4). The application of blockchain in the legal sector. https://www.thomsonreuters.com/en/reports/blockchain.html
