Sold by: Incedo Inc
AI-powered control document automation solution for life sciences organizations to streamline clinical trial compliance, reduce manual effort, and improve audit readiness. Built on AWS, it converts complex source materials into consistent, explainable, and review-ready control documentation.
Overview
Accelerate Compliance Documentation Across Clinical Trials
Clinical trial programs depend on accurate and timely control documentation to demonstrate compliance, support governance, and prepare for audits. Yet creating these documents often requires teams to manually interpret rules, review multiple source files, reconcile data from disconnected systems, and compile outputs under tight timelines.
Incedo Clinical Trial Control Document Automation modernizes this process with AI-driven extraction, interpretation, and document generation. The platform helps organizations move from labor-intensive manual preparation to faster, more scalable, and consistently governed compliance documentation across trials and programs.
Why Traditional Documentation Processes Create Delays
Control documentation is frequently assembled from PDFs, PowerPoint decks, spreadsheets, text files, SOPs, and operational systems. Teams must interpret changing requirements, validate evidence, and manually create documents for each study or program.
This creates long turnaround times, inconsistent outputs, dependency on specialist knowledge, repeated review cycles, and higher compliance risk when programs scale.
How the Platform Creates Value
The platform ingests multiple source formats including PDF, PPT, text, and structured system data. AI engines extract requirements, interpret compliance rules, connect supporting evidence, and generate audit-ready control documents with clear rationale and explainable reasoning.
A human-in-the-loop workflow supports review, approval, and final signoff—ensuring organizations retain governance control while benefiting from automation.
Built Using AWS Services
The solution is built on AWS and can leverage Amazon Bedrock for generative AI reasoning and content generation, Amazon Textract for document extraction, Amazon Comprehend for language understanding, Amazon SageMaker for model optimization, Amazon S3 for secure document storage, AWS Lambda for workflow automation, Amazon OpenSearch Service for intelligent retrieval, and Amazon QuickSight for compliance dashboards and productivity reporting.
What This Enables
Organizations gain faster control document creation, reduced manual interpretation effort, more consistent outputs across studies, stronger traceability, scalable compliance operations, and improved readiness for audits and inspections.
Why It Matters
With the right automation in place, life sciences teams can shorten documentation cycles, reduce operational burden, improve quality and consistency, scale support across multiple trials, and strengthen confidence in compliance execution.
Highlights
- Extracts and interprets compliance rules from PDFs, presentations, text, and enterprise data sources to automate control documentation.
- Generates audit-ready documents with explainable reasoning, supporting faster preparation and stronger governance confidence.
- Human-in-the-loop review and approval workflows combine AI efficiency with expert oversight across trials and programs.
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.
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.
Resources
Vendor resources
Support
Vendor support
For product support, implementation assistance, and technical inquiries, customers can contact the Incedo support team:
Website: https://www.incedoinc.com
**Email**: <Partnerships_Alliances@incedoinc.com>Incedo provides support across platform implementation, source integration, workflow setup, AI tuning, governance configuration, user enablement, and ongoing optimization.
Software associated with this service
By Incedo Inc
BrainSpark Agent offers a cutting-edge Gen AI platform designed to enhance enterprise productivity across three pivotal domains: Software Development Life Cycle (SDLC), Customer Operations, and Middle/Back Office Operations. Leveraging BrainSpark's Model hub, enterprises can efficiently contextualize Large Language Models (LLMs) to their specific data landscapes, thereby optimizing the accuracy and efficacy of their Gen AI initiatives. Furthermore, seamless integrations with established enterprise platforms such as JIRA and Azure Devops streamline the adoption process, empowering organizations to swiftly harness the transformative potential of BrainSpark's advanced solutions.
By Incedo Inc
Boost business IQ and ignite growth with Incedo Lighthouse, a powerful AI & GenAI-powered platform that transforms your data into actionable insights. Leveraging a unique MECE-based KPI Tree structure, Lighthouse provides crystal-clear visibility into your business via data, enabling you with problem structuring, problem discovery and closing the critical data-insights-actions loop seamlessly. With AI-driven anomaly detection, powerful cohort segmentation, key driver analysis, cutting-edge GenAI insights, a user-friendly visualization studio, and a seamless data-insights-action loop, Lighthouse simplifies complex analytics, uncovers hidden opportunities, and empowers you to make data-driven decisions that fuel sustainable growth.