Sold by: Dedicatted
Dedicatted's GenAI on AWS automates summarization of clinical trial data (CSRs, stats, safety) into regulatory-ready formats for FDA/EMA submissions. Life sciences teams cut months from review cycles while ensuring accuracy and auditability.
Overview
Service Overview
Clinical trials produce terabytes of unstructured data; manual summarization delays regulatory filings by months. This AWS solution uses Bedrock to extract insights, generate summaries, and draft eCTD modules with traceable reasoning.
What We Deliver
- Automated CSR summaries, patient narratives, and safety signals
- Regulatory module drafts (e.g., 2.7.3, 2.7.4) compliant with ICH guidelines
- Query response generation for agencies
- Integration with Veeva, electronic vaults
Key Features
- Data extraction – Parses PDFs, EDC, SAS outputs for efficacy/safety insights.
- Summarization – Hierarchical abstracts from full datasets.
- Regulatory drafting – Generates tables, narratives in eCTD format.
- Compliance traceability – Citations back to source data
Business Results
- 50% faster submission preparation.
- Reduced queries from regulators
- Accelerated time-to-market for therapies.
Highlights
- Summarize CSRs, safety data, stats into regulatory narratives using Amazon Bedrock
- Draft eCTD modules (2.7.x) and agency query responses with source traceability
- Cut submission time 50% for faster FDA/EMA approvals
Details
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Delivery method
Deployed on AWS
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Support
Vendor support
Support Details:
At Dedicatted, we are committed to providing our customers with exceptional support to ensure they receive the most value from our product. Customers who purchase our product can expect to receive the following level of support:
Contact information: Customers can reach out to us via email at contact@dedicatted.com or through our website.
Support channels: We offer a variety of support channels to ensure our customers receive timely and efficient support. Our support channels include:
- Email: Customers can email our support team at any time with questions or issues. We strive to respond within 24 hours.
- Google Chat: Customers can chat with our support team in real-time to get quick answers to their questions or assistance with any issues they may be experiencing.
- Phone support: Customers can call our support team during business hours, Monday through Friday, from 9 am to 5 pm EST.
Support level: We provide technical support for our product, including assistance with installation, configuration, and troubleshooting. Additionally, we offer guidance and best practices to help customers optimize their DevOps processes.
Overall, our goal is to ensure our customers receive exceptional support and have a positive experience with our product. We are committed to helping our customers achieve success with their DevOps processes and AWS cloud adoption.