Leveraging AI-powered Content Generation to Streamline Clinical Trial Documentation and Enhance Research Workflow Efficiency
The Challenge
The Therapeutics Division faced significant challenges in managing clinical trial documentation, requiring an innovative solution to streamline and accelerate the process.
- Manual Data Entry: Clinical trial data and templates were analyzed and populated manually, resulting in inefficiencies and delays.
- High Risk of Errors: Human errors in documentation compromised accuracy, impacting regulatory compliance and research integrity.
- Diverse File Formats: Clinical trial results were stored across multiple formats, including PDFs, PowerPoint presentations, Excel sheets, and Word documents, making data extraction complex and inconsistent.
- Time-Consuming Processes: Manual workflows slowed down decision-making, delaying research progress and documentation approvals.
- Scaling Challenges: As the volume of clinical trial data grew, managing and processing documentation without automation became increasingly difficult.
Without a unified, AI-driven solution, researchers and regulatory teams struggled with inefficiencies, data inconsistencies, and delays in clinical documentation, impacting overall trial timelines and compliance efforts.
Our Solution
Agilisium developed an AI-driven documentation solution leveraging Retrieval Augmented Generation (RAG) and AWS Bedrock's Claude Sonnet LLM to automate form-filling and streamline documentation processes.
Data Sources:
- Clinical Trial Reports (PDF, Word) – Experimental results and research findings.
- Presentation Slides (PowerPoint) – Visual data and summaries from clinical trials.
- Data Sheets (Excel) – Structured data, tables, and quantitative analysis from trials.
- Regulatory Documents (PDF, Word) – Compliance guidelines and submission forms.
Key Features Include:
Automated Form-Filling
AI extracts dynamic fields from templates and populates them with relevant information from source documents.
Multi-Format Support
Seamlessly processes PDFs, PowerPoints, Excel, and Word files, ensuring efficient data integration.
Error Reduction
Reduces human errors, ensuring more accurate and compliant documentation.
Process Automation
Speeds up documentation processing, allowing researchers to focus on core scientific tasks.
Scalable Cloud Deployment
Hosted on AWS, the solution handles large volumes of clinical trial documentation efficiently.
The Outcomes
Agilisium’s AI-driven solution revolutionizes clinical trial documentation by automating data extraction, reducing errors, and accelerating workflows. Researchers can generate accurate, compliant documents in a fraction of the time, ensuring faster regulatory approvals and enhanced operational efficiency.
Innovation Award Winner: The PoC for "Study Startup Documents" using GenAI was recognized for enabling self-service document creation. By leveraging AI-driven automation, Agilisium empowered the client’s research teams with faster, error-free, and scalable documentation solutions, revolutionizing clinical trial workflows.
Enhanced Data Accuracy
Automated extraction and form-filling significantly reduce human errors, improving the reliability of documentation.
Faster Time to Market
Accelerates the clinical trial timeline, enabling quicker submissions and approvals.
Improved Operational Efficiency
Researchers can focus on high-value tasks instead of administrative documentation.
Enhanced Regulatory Compliance
Automated quality checks ensure adherence to compliance standards.
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