Leveraging AI, LLMs and master data management to optimize clinical trial site selection

Clinical trials present significant bottlenecks in pharmaceutical development, with site selection emerging as a critical determinant of success. This article examines how artificial intelligence (AI), large language models (LLMs), and Master Data Management (MDM) systems can be integrated to transform the site selection process. Traditional site selection relies heavily on manual processes, siloed data systems, and subjective decision-making, resulting in suboptimal outcomes and delays. By leveraging AI algorithms to evaluate historical performance across multiple dimensions, assess investigator capabilities, align site demographics with trial requirements, and identify potential risks before they manifest, pharmaceutical companies can move beyond experience-based selection toward data-driven decision-making. MDM systems provide the essential foundation by creating unified data repositories, implementing governance protocols, and enabling real-time performance monitoring. The synergistic integration of these technologies delivers substantial benefits including accelerated site identification, enhanced performance forecasting, compressed activation timelines, optimized patient recruitment, improved diversity and inclusion, proactive risk management, and significant cost avoidance. A phased implementation roadmap offers organizations a structured path to realize these benefits while ensuring sustainable value creation.

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Publication Details

Journal
Zenodo (CERN European Organization for Nuclear Research)
Published
2025-04-30
DOI
https://doi.org/10.5281/zenodo.17231872
Primary Topic
Machine Learning in Bioinformatics
Type
article
Field-Weighted Citation Impact
0.00
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article

Leveraging AI, LLMs and master data management to optimize clinical trial site selection

Zenodo (CERN European Organization for Nuclear Research)
Machine Learning in Bioinformatics
article

Leveraging AI, LLMs and master data management to optimize clinical trial site selection

article en

Abstract

Clinical trials present significant bottlenecks in pharmaceutical development, with site selection emerging as a critical determinant of success. This article examines how artificial intelligence (AI), large language models (LLMs), and Master Data Management (MDM) systems can be integrated to transform the site selection process. Traditional site selection relies heavily on manual processes, siloed data systems, and subjective decision-making, resulting in suboptimal outcomes and delays. By leveraging AI algorithms to evaluate historical performance across multiple dimensions, assess investigator capabilities, align site demographics with trial requirements, and identify potential risks before they manifest, pharmaceutical companies can move beyond experience-based selection toward data-driven decision-making. MDM systems provide the essential foundation by creating unified data repositories, implementing governance protocols, and enabling real-time performance monitoring. The synergistic integration of these technologies delivers substantial benefits including accelerated site identification, enhanced performance forecasting, compressed activation timelines, optimized patient recruitment, improved diversity and inclusion, proactive risk management, and significant cost avoidance. A phased implementation roadmap offers organizations a structured path to realize these benefits while ensuring sustainable value creation.

Zenodo (CERN European Organization for Nuclear Research)
Gene Therapy Laboratory (FR)
Reduced inequalities
Openalex Percentile: Top 49%
Machine Learning in Bioinformatics
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Leveraging AI, LLMs and master data management to optimize clinical trial site selection · Zenodo (CERN European Organization for Nuclear Research) (2025) | TGRS Research Map | TGRS