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 (for example 2.7.3 and 2.7.4) structured to ICH guidelines for expert review
- 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
- Faster submission preparation, with every draft reviewed by your experts.
- Reduced queries from regulators
- Accelerated time-to-market for therapies.
Credentials
Dedicatted holds the AWS Healthcare Consulting Competency, the AWS Financial Services Consulting Competency and the AWS Cloud Operations Services Competency, and is in the AWS Managed Service Provider Program.
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
- Shorten submission preparation with drafts your regulatory team reviews and approves
Details
Sold by
Delivery method
Deployed on AWS
New
Introducing multi-product solutions
You can now purchase comprehensive solutions tailored to use cases and industries.
Features and programs
Trust Center
Access real-time vendor security and compliance information through their Trust Center powered by Drata or Vanta. Review certifications and security standards before purchase.
Pricing
Custom pricing options
Pricing is based on your specific requirements and eligibility. To get a custom quote for your needs, request a private offer.
Legal
Content disclaimer
Vendors are responsible for their product descriptions and other product content. AWS does not warrant that vendors' product descriptions or other product content are accurate, complete, reliable, current, or error-free.
Support
Vendor support
Contact
- Email: contact@dedicatted.com
- Contact form: https://dedicatted.com/contact
Support channels
- Email: any time, with a response within two business days.
- Google Chat: real-time answers from our support team.
- Phone: business hours, Monday to Friday, 9 am to 5 pm EST.
What support covers
- Technical support for the service, including help with installation, configuration and troubleshooting.
- Guidance and best practices for your DevOps processes and AWS cloud adoption.