AIMED DOCUMENTA©
From Concept to Live EDC in Hours, Not Months
AIMED DOCUMENTA© is our advanced Agentic AI application that revolutionizes clinical research by transforming your study concept into a fully compliant digital protocol – complete with auto-generated EDC – in mere hours instead of months.
The Challenge We Solve
The drug development journey averages 10 years and an estimated $2.4 billion, with approximately 80% of this investment directly attributable to the clinical trial phase. Traditional protocol development—from initial concept to validated eCRF—is characterized by intricate complexity, labor-intensive manual processes, and extensive time and resource requirements involving medical writers, study managers, and data managers.
AIMED DOCUMENTA© transforms this paradigm entirely.
How It Works
1. Concept In
Define your population, arms, endpoints, and outcomes. Our system takes into consideration your inputs while providing direct access to medical literature databases and supporting importation of sponsor unpublished documents.
2. Protocol Out
Receive TransCelerate-aligned authoring grounded in PubMed plus your proprietary documents. AIMED DOCUMENTA© generates three alternative study designs including complete sample size calculations, allowing you to select the optimal approach for your research objectives.
3. USDM Core
Your protocol is delivered in machine-readable USDM (Unified Standard Definition Model) format, establishing a Single Source of Truth (SSoT) that structures all protocol elements consistently and interoperably, enabling seamless data exchange across your clinical operations ecosystem.
4. Standard Definition Repository (SDR)
Access a comprehensive library of standardized elements including endpoints, visits, and procedures—ensuring consistency and accelerating development.
5. Reference Implementation (RI)
Our template engine and services layer makes content consumable by all downstream systems, from regulatory submissions to site operations
6. DDF → EDC
From the structured protocol, automatically build CRFs, schedules, edit checks, and live EDC scaffold—eliminating weeks of manual configuration.
What Gets Generated
From a single structured protocol, AIMED DOCUMENTA© automatically produces:
- Informed Consent Forms (ICFs)
- Electronic Case Report Forms (eCRFs)
- Comprehensive Data Management Plans
- Project Management Plans
- Visit schedules and assessment matrices
- Edit checks and validation rules
- And various other crucial operational study assets
Benefits
Lower Start-up Costs – Fewer handoffs and less rework equals immediate savings on every study you launch.
Eliminate Non-Value Work – Automate reformatting and specification churn so your teams can focus on science.
Unlock Analytics – USDM structure powers feasibility, complexity, cost, and risk views before you commit resources.
Flexible Interoperability – Exchange seamlessly across partners with USDM, TransCelerate, and DDF standards.
Quality & Consistency – Change once; updates propagate across protocol, CRFs, and all derived documents automatically.
The AIMED DOCUMENTA© Advantage
Built with end-to-end traceability, AIMED DOCUMENTA© ensures every element of your protocol can be traced back to its source, whether scientific literature, sponsor specifications or regulatory requirements. This unprecedented transparency accelerates regulatory reviews and builds stakeholder confidence.
Our Agentic AI doesn’t just automate, it elevates. By combining deep clinical research expertise with advanced AI capabilities, AIMED DOCUMENTA© delivers protocols of superior quality while eliminating the manual steps, costly rework, and time-consuming specification adjustment cycles that plague traditional development.
Ready to Transform Your Clinical Trials?
Whether you’re launching a pivotal Phase III study or an innovative real-world evidence program, AIMED DOCUMENTA© can dramatically accelerate your timeline, potentially saving months of invaluable time and resources.
All Our Services
GenAI-Driven Synthetic Control Arm
GenAI-Driven RWD Acquisition & Analysis
Target Trial Emulation for Drug Repurposing
Realistic and Privacy-guarantees Synthetic Patient Data
AIMED Documenta
Patient’s Data De-Identifier
GenAI-Driven Remote Verbal Consent
CONTACT DETAILS
info@aimedtrial.com
+39 3482630229