CASE STUDY

Pharmacovigilance in Rare Disease Trials using AI & NLP

Context

A healthcare client needed to analyze free-text narratives from adverse event (AE) reports in a large Phase IV rare disease trial. Traditional MedDRA coding focused only on structured terminology and often overlooked subtle safety signals described in investigator comments. This limited visibility into emerging risks and delayed proactive intervention.

Resolution

Our team implemented a natural language processing (NLP) pipeline tailored for pharmacovigilance. Using spaCy for text preprocessing (tokenization, lemmatization, stopword removal) and Gensim’s LDA for topic modeling, we surfaced hidden AE themes. To detect recurring rare events with inconsistent coding, we employed Sentence-BERT embeddings and HDBSCAN clustering. These insights were integrated with structured AE datasets and visualized through interactive safety signal graphs using NetworkX and Plotly.

Result

The AI-powered solution identified a previously undetected neurotoxic symptom cluster in a small patient subgroup. This early detection allowed for timely safety actions, streamlined pharmacovigilance operations, and demonstrated the effectiveness of combining AI and NLP for enhanced post-trial safety monitoring.

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    Pharmacovigilance in Rare Disease Trials using AI & NLP

    Context

    A healthcare client needed to analyze free-text narratives from adverse event (AE) reports in a large Phase IV rare disease trial. Traditional MedDRA coding focused only on structured terminology and often overlooked subtle safety signals described in investigator comments. This limited visibility into emerging risks and delayed proactive intervention.

    Resolution

    Our team implemented a natural language processing (NLP) pipeline tailored for pharmacovigilance. Using spaCy for text preprocessing (tokenization, lemmatization, stopword removal) and Gensim’s LDA for topic modeling, we surfaced hidden AE themes. To detect recurring rare events with inconsistent coding, we employed Sentence-BERT embeddings and HDBSCAN clustering. These insights were integrated with structured AE datasets and visualized through interactive safety signal graphs using NetworkX and Plotly.

    Result

    The AI-powered solution identified a previously undetected neurotoxic symptom cluster in a small patient subgroup. This early detection allowed for timely safety actions, streamlined pharmacovigilance operations, and demonstrated the effectiveness of combining AI and NLP for enhanced post-trial safety monitoring.

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    Headquartered in New Jersey, Rang Technologies has dedicated over a decade delivering innovative solutions and best talent to help businesses get the most out of the latest technologies in their digital transformation journey. Rang Technologies has grown to become a global leader in Analytics, Data Science, Artificial Intelligence, Machine Learning, Salesforce CRM, Cloud, DevOps, Internet of Things (IoT), Cybersecurity, IT Consulting and Staffing, and Corporate Training. Our clients, which include Fortune 500 to Start-up companies, come from a wide array of industries, including pharmaceuticals, healthcare, retail, technology, BFSI, media, automobile, manufacturing, and several others. Our clients know they can rely on Rang Technologies to deliver customized and comprehensive digital solutions and talent to complement their business and technical objectives.

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