Replace Human Data Entry with TheraLyze.AI
TheraLyze Safety AI eliminates manual data entry and reduces case processing time, resulting in cost savings, enhanced speed, greater efficiency and scalability.
Leveraging cutting-edge AI and natural language processing (NLP), TheraLyze.ai converts unstructured safety data into E2B R3 files, ready for seamless integration into any pharmacovigilance database. With GDPR and HIPAA compliance at its core, TheraLyze.ai is driving real-world results—as demonstrated by our success with Wörwag Pharma.
Problem with Drug Safety Landscape
Pharmacovigilance is at the core of patient safety, but traditional case intake processes are time-intensive, error-prone, and costly. The growing volume of safety data requires innovative solutions to address these challenges. TheraLyze.ai leverages AI to automate the case intake process, enabling organizations to focus on high-value activities like risk assessment and regulatory compliance.
TheraLyze.ai doesn't require customer data to train our models.
Zero configuration setup to process any safety documents.
Cost effective, Scalable. High Quality and reduces total time required to process cases.
Plug ‘n play via API, Source Type & PV DB agnostic
How it works
Step-by-Step Process:
File Upload: Users upload safety documents (e.g., PDFs, Word files, or images) via a secure interface, API on other omni channels.
AI Processing: The platform processes the files using advanced AI algorithms to extract relevant safety information, apply MedDRA and WHO Drug coding, and structure the data into ICH compliant E2B R3 XML format.
Output Delivery: Once processing is complete, users or systems can download the E2B R3 files directly from the same interface, API or other to upload into their pharmacovigilance database.
Business Benefits
TheraLyze.ai delivers measurable benefits that transform pharmacovigilance operations:
Efficiency: Eliminate manual data entry and accelerate case processing.
Scalability: Handle growing volumes of ICSRs with ease.
Cost Savings: Reduce operational costs through automation.
Compliance: Ensure GDPR and HIPAA compliance.
Enhanced Quality: Confidence scoring and intuitive UI for error reduction
Features
No configuration or recipes required to support the new source data file format.
No customer data required to train TheraLyze.ai Machine Learning Models.
Automated Case Entry:
Extract event and medical information using NLP and populate safety field automatically.
Medical Coding:
Perform MedDRA and WHO Drug coding for adverse reactions, indications, and concomitant drugs.
Duplicate Detection:
Identify duplicate AERs or case follow-ups efficiently.
Intuitive Interface:
Confidence scores guide users to verify and validate safety data.
Omni-Channel Intake:
Supports multiple formats (text, PDF, XML, etc.) and intake channels (API, email, UI).
Data Security:
Redact PHI and PII while maintaining compliance with GDPR and HIPAA.
Database Integration:
Seamlessly integrate with any pharmacovigilance database via E2B R3 endpoints.
Case Study: Wörwag Pharma
Background
Wörwag Pharma, a leading pharmaceutical company in Germany, sought a solution to streamline its pharmacovigilance case intake process.
Challenges
Manual data entry was time-consuming and prone to errors.
Scaling case intake operations with increasing data volumes was challenging.
Ensuring compliance with EMA’s stringent regulatory requirements.
Solution
By adopting TheraLyze.ai, Wörwag Pharma automated its case intake process. The platform converted unstructured safety data into structured E2B R3 files with near-perfect accuracy, eliminating manual entry and significantly reducing quality control time.
Results
Successful submission of AI-generated ICSRs to EMA.
Substantial reduction in case processing time.
Cost savings and improved operational efficiency.
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