Overview
ECCOM has created an intelligent clinical document validation product based on Amazon Bedrock, aimed at solving the efficiency bottlenecks and data consistency challenges pharmaceutical companies face during the integration of clinical study reports. By deeply integrating generative AI with the AWS cloud-native architecture, this service achieves full-process automation from document parsing and discrepancy comparison to the generation of revision suggestions.
Main Features
• Amazon Bedrock-Driven Intelligent Core: Utilizes large language models on Amazon Bedrock, combined with text embedding and reranking models deployed via SageMaker, to accurately understand complex medical terminology and document logic.
• Intelligent Document Processing Engine: Supports the parsing of multiple formats such as Excel and CSV. Through Markdown conversion and intelligent chunking by chapters/tables, it automatically handles cross-page table merging and extracts metadata (e.g., page numbers, titles, languages) to build structured data.
• Precise Revision and Traceability: Leverages prompt engineering to achieve "table-paragraph" linked validation. It not only identifies data errors but also automatically locates and updates the corresponding descriptive paragraphs based on table changes, while providing specific suggested correction values.
• Full-Stack AWS Architecture: The solution is strictly built upon the AWS infrastructure. Core components include Amazon EC2 (application hosting), Amazon S3 (document storage), Amazon OpenSearch (knowledge base indexing), and Amazon SageMaker (model inference), ensuring enterprise-grade stability and security.
• Compliance and Access Control: The main program is deployed in a private EC2 environment and is only accessible to authorized business users. All data uploaded by users remains within the customer's own S3 buckets, strictly complying with the data compliance requirements of the HCLS (Healthcare and Life Sciences) industry.
• Universal Adaptability: As a universal platform, it can flexibly adapt to the document specifications and validation standards of different pharmaceutical companies, eliminating the need for repetitive development for specific templates.
Business Benefits
• Significantly Improves Writing Efficiency: Frees medical writers from tedious manual data extraction and verification tasks, reducing the document processing cycle by over 60%.
• Ensures Zero Data Errors: Eliminates human errors caused by manual copy-pasting, guaranteeing the data consistency and accuracy of clinical study reports throughout their entire lifecycle.
• Accelerates the New Drug Application Process: High-quality document output directly improves the success rate and speed of submissions to regulatory agencies, accelerating the drug launch process.
• Reduces Operational Costs: Uses automation to reduce the time invested by senior medical writers in basic proofreading, optimizing human resource allocation.
Highlights
- Amazon Bedrock-Driven Intelligent Core: Integrates Amazon Bedrock large language models with text embedding and reranking models deployed via SageMaker to precisely parse complex medical terminology and document logic.
- "Table-Paragraph" Linked Validation: Achieves cross-modal associative validation through prompt engineering, automatically locating the descriptive paragraphs corresponding to table changes and providing specific revision suggestions.
- Full-Stack AWS Compliant Architecture: Relies on native services such as EC2, S3, and OpenSearch to build a private deployment solution, strictly adhering to the data security and access control requirements of the HCLS industry.
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