How to turn clinical studies into actionable and reusable data
How to turn clinical studies into actionable and reusable data?
Smart automation of clinical study processing enables to easily retrieve, summarise and reuse content for Regulatory drafting:
- Decrease human review time by at least 80%
- Easily search and retrieve selected pieces
- Run analyses across documents
- Feed automated drafting tools to cut submission times
- Whilst using GxP compliant systems
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Why Pharma companies deploy smart automation on clinical studies?
Besides tangible ROI and productivity gains, smart automation dramatically frees up time of your professional teams and keeps their eyes on things that really matters.
Save time and gain speed in clinical study ingestion
Smart automation eliminates manual review by instantly analysing and structuring information across hundreds of studies. Teams can search, compare, and extract key data in seconds—cutting review time by over 80% and accelerating every following step of drafting and analysis.
Gain new insights on patterns and correlations
By transforming unstructured study reports into searchable, structured data, smart automation uncovers patterns and hidden relationships. Teams can run cross-study analyses, compare outcomes, and identify emerging trends in minutes - unlocking insights to drive faster actions.
Accelerate regulatory drafting
Whether you want to answer a question, prepare a meeting with authorities or populate eCTD authoring tools, smart automation drastically accelerates your drafting cycles, reduces manual compilation errors, whilst providing reliable and traceable outputs.
How you can achieve massive productivity gains with limited setup costs:
Smart automation of clinical studies and associated documents can be implemented based on your current input channels and DMS, with flexible workflows and a combination of immediate on-screen outputs and API exports:
No major process changes, feed your current sources into a flexible workflow
Let the algorithms analyse and chunk the documents, extracting all tables, graphs, text with their context
Get answers on your questions on one or all studies through an NLP interface (e.g. similar to ChatGPT)
Automatically feed the now structured data into analytical systems, enabling deeper work on correlations, trends and outliers
Automatically feed data in structured format into drafting automation tools
Stay in control with human-in-the-loop steps, confidence scores and full traceability to the source
How document chunking creates directly usable and reliable outputs for Pharma companies?
Models chunk the data and keeps the context
The system automatically breaks down complex clinical documents into meaningful components - such as objectives, methodologies, results, actual values in all tables - while preserving their full context and metadata. This structured foundation allows precise retrieval, consistent interpretation, and seamless reuse of information across analyses and reporting.
Get answers, summaries and drafts through an NLP interface
With a natural language interface (e.g. chat), users can simply ask questions or request summaries to instantly retrieve precise information from processed studies. The system understands context, compiles relevant data, and can even generate first-draft content for faster document preparation, whilst displaying the exact sources on the same screen to facilitate cross-checking.
Feed analytical and drafting systems with FAIR data
Processed study data is delivered in a structured, machine-readable format that meets FAIR principles - findable, accessible, interoperable, and reusable. This ensures seamless integration with analytical platforms and drafting tools, enabling consistent, automated use of high-quality data across workflows.
Based on machine learning models tailored to Quality & Regulatory needs
GxP compliance by design, providing full traceability, auditability and replicability
Highest accuracy for complex documents, through document & table specific models
Models are fine-tuned on your data for precision and privacy. Your models, your data.
Human-in-the-loop interfaces to ensure validity and compliance of data and models
Traceability back to the source, for auditing and versioning, and avoiding the risk of hallucination
Phased implementation is the key for a quick ROI and long-term scalability
Breaking down complexity in steps:
1/ Initial feasibility and scoping: 3 weeks
- Running test documents
- Aligning on objectives and implementation
2/ Implement the first solution: 1 month
- Implement solution on first 50-100 studies
- Configurate rules and actions
3/ Improve the solution: 2 months
- Take user feedback to improve the solution and configuration
- Define path and integration for scaling-up
4/ Roll out across products: 6 months
- Build integrations and train users
- Roll-out across sources and teams
Download our client implementation case study
Download the PDF case study to see how we implemented smart automation on the Batch Records of a large Pharmaceutical company
Typical industry challenges
R&D and Regulatory teams spend a lot of time searching and compiling content
Standard LLMs do not provide the required accuracy and reliability
Standard IDP solutions do not provide direct value to the end-users
Our data and processes are too sensitive to be shared.
How we solve it
Smart automation makes the content easy to search, analyse and summarise
Our proprietary ML models are trained only on Pharma documents
Our platform integrates the ingestion, direct interactions and API outputs
Models dedicated to you run in your own instance. Nothing is shared.
What Do our Customers Say about Acodis?
Very easy and fast implementation with different connection possibilities.
Excellent Customer Service, a fast response time and solution
Vinyo D.
Project Manager IT
An outstanding data extraction solution - intuitive, flexible, and backed by excellent technical support. The team's responsiveness and expertise made all the difference. Highly recommended!
George B.
Quality Manager, Pharma
Document processing solution to extract data from static documents for non-expert users
Thomas H.
Business Architect, Agrochemical
The user friendly interface was simple to operate and did not require data engineering expertise.
Shannon M.
Digital Project Manager, Pharma
Certifications & Data Privacy
Frequently asked questions
Why would your models understand our clinical studies better than state-of-the art OpenAI LLMs?
Whilst LLMs are trained on the global web content, our models are trained specifically on quality and regulatory documents. When our system ingests a clinical study, it will run 15 separate models, each trained to understand specific components with accuracy (titles, tables, footnotes, etc.).
As these models are proprietary to Acodis, it is much more cost effective and traceable than systems relying purely on external LLMs.
Finally, our system can also integrate LLM post-processing, so clients actually get the best of both worlds !
Concretely, what can I get out of the systems in a few weeks?
In a couple of hours we can setup a dedicated instance and run our standard models on your studies. You immediately get the ability to query such documents through an interface similar to ChatGPT, enabling you to answer any questions, get summaries and draft pieces of content. Always with the access on-screen to the source document. So you can make sure that the output is conform to the actual content.
Within a few weeks, we can work further on the patterns of your documents and create outputs that address your business needs in a more automated fashion.
Does Acodis support GxP compliance and validation requirements?
Yes. Acodis is built to support GxP-regulated environments and aligns with GMP-compliant documentation requirements. The platform ensures traceability, complete audit trails, version control, and robust data integrity — all critical for regulated processes.
What types of documents and formats can Acodis handle, including handwritten or scanned files?
Acodis can handle a broad range of document types, including PDFs, Word files, Excel sheets, PowerPoint decks, scanned documents, images, & even handwritten text. Whether your documents are structured, semi-structured, or entirely unstructured, Acodis extracts the relevant data accurately. Even from complex formats like tables, multi-page reports, or low-quality scans.
Can Acodis integrate with our current systems (like LIMS, QMS, ERP)?
Yes. Acodis integrates seamlessly with existing enterprise systems such as LIMS, QMS, ERP, and other document or data platforms. As a SaaS solution, it supports flexible integration options including REST APIs, FTP, and other standard protocols, whether you're working in a cloud, hybrid, or on-premise environment.