AI-Powered Innovative Practice in Drug Regulatory Review for a Fortune 500 Medical Device Company - Industry Cases

Client Profile

This client is a prestigious Fortune 500 company, continuously developing innovative products and enriching its service portfolio, including AI-based applications and digital products, playing an increasingly important role in the development of next-generation medical technologies.

Business Challenges

Before launching medical device products, companies must familiarize themselves with strict and complex review standards and analyze the vast amount of information in the drug administration's guidance documents. The company urgently needed an intelligent solution to enhance knowledge management efficiency and improve the approval rate to boost its market competitiveness.

Numerous and Strict Review Standards for Product Launch
￮Cumbersome Perusal of Drug Administration Documents: Preparing products for market launch requires compliance with multiple drug administration guidelines, demanding significant time for deep analysis.
￮Heavy Review Training: Review training covers multiple fields such as technology, clinical functions, and requires multiple cross-departmental meetings for thorough study.

￮Manual Compilation of Historical Replies from the Drug Administration: Organizing past documents from the drug administration requires a significant amount of manual copy-pasting, leading to high error rates and time consumption.
￮Difficulty in Quickly Identifying Key Information: Quickly locating key elements in stylistically varied documents is highly challenging.
￮High Costs of Manual Data Cleaning: Documents in PDF format, despite the use of OCR processing, still require extensive manual data cleaning, leading to high costs.
￮High Cost and Error-Prone Manual Copying: Manual copying often results in data format loss, high error rates, and consumes a lot of time and effort.
￮Knowledge Extraction is Time-Consuming and Labor-Intensive: The process of converting document knowledge into actionable insights is arduous and time-intensive when done manually.

Solution

Smart Vision's proprietary RAID platform automates key point extraction from drug administration documents, generating summaries and training content, and simulating committee questions to boost review approval rates.

Key Features:

One-Click Summarization: Quickly generate summaries and monitor updates by importing PDF and Word guidance documents.
Rapid Training Updates: Efficiently create and maintain training materials with automatic knowledge base updates.
Reviewer Profiles: Automatically build reviewer profiles and tailor content strategies, enhancing review success.
Efficient Information Extraction: Custom parsing rules capture core data swiftly, regardless of document style.
Multi-Language Support: Parse documents in Chinese, English, French, and more, generating structured data for global use.

Solution Advantages

One-Click Document Analysis:
RAID platform quickly imports PDF and Word drug guidance documents and auto-generates summary reports, reducing response time to policy updates.
Knowledge Updates:
The platform efficiently generates and updates training materials, ensuring timely and relevant knowledge integration as policies and technologies evolve.
Targeted Reviewer Standards:
RAID builds reviewer profiles from collected data, enabling customized training strategies and review simulations, improving approval rates.
Efficient Information Extraction:
With custom parsing rules, RAID swiftly captures core information from documents, enhancing accuracy and speed while reducing manual errors.
Global Multi-Language Support:
RAID supports parsing in multiple languages, generating structured data for international markets and boosting global competitiveness.

Values

Significant Improvement in Document Handling Speed

Transition from manually copying and pasting up to 20 documents per person per day to automated processing, reducing the time to just 2 minutes per document.

Instant Training Knowledge Update System

Shifting from manually organizing training materials to automated FAQ maintenance and updates, it greatly enhances efficiency.

Intelligent Reviewer Profile Generation

Moving from the difficulty of predicting reviewer questions to the ability to simulate reviewer questioning patterns, it now has a higher pass rate of evaluations.

Instant Generation of Replies for Drug Administration Review

Writing responses to the administration was always time-consuming and required cross-department collaboration. Now it only needs a few people to prepare for the review process.

Other Applications

Bid Document Analysis

With the ability to intelligently extract key information from bid documents, companies can efficiently gather competitor information in an efficient way.

Product Manual Analysis

Automated extraction of product specification information allows for a faster accumulation of corporate data assets.

Financial Report Analysis

Companies can rapidly extract core data from financial statements and integrate it with historical records to reveal data changes and trend directions.

Paper Summarization

Intelligent summarization of paper highlights, helping researchers quickly capture key arguments and significantly enhancing the efficiency of literature review.

Intelligent Q&A on Regulations

With the ability to immediately extract key points from legal documents and the use of an intelligent Q&A system, companies can quickly respond to users' legal consultations.