DATAN Analytics AI+

DATAN Analytics AI+ is a specialised AI-powered automation platform designed for clinical development teams. It deploys purpose-trained AI agents to handle routine, time-intensive tasks across the full clinical study lifecycle — from eCRF design through to the final Clinical Study Report. The platform is built for pharmaceutical companies, CROs, and clinical data management professionals who need to reduce manual effort, minimise errors, and maintain strict regulatory compliance without requiring any programming knowledge.

By combining specialised AI agents with automated workflows, DATAN Analytics AI+ enables teams to complete tasks in hours rather than days, with cycle time reductions of up to 80%. The platform operates entirely within a secure, GDPR-compliant EU environment, and humans retain full oversight and final decision-making authority at every step.

Key Benefits

• Significant reduction in errors through intelligent automation of repetitive tasks
• No coding required — fully operable via an intuitive browser-based interface
• EU hosting and full GDPR compliance for maximum data security
• Automatic selection of the most appropriate large language model (LLM) for each task
• Allows clinical teams to focus on high-value work by delegating routine processes to AI agents

Supported Use Cases Across the Clinical Study Lifecycle

• eCRF Design & Validation: Agents automatically generate eCRF specifications and plausibility rules, ensuring consistent data logic from day one and saving significant set-up time.
• Edit-Check Specifications / IDRP: DATAN Analytics AI+ generates integrated data review plans automatically.
• Data Management Plan (DMP): Study-specific parameters are used to populate and automatically update DMP templates, ensuring GxP conformity without copy-paste errors.
• Monitoring Plan: Risk-based monitoring concepts are used to define the monitoring plan, enabling targeted resource allocation and reduced monitoring costs.
• Statistical Analysis Plan (SAP): Based on your existing template, an agent generates the full SAP including methodology sections and sample code, reducing review times dramatically — hours instead of days.
• Mock Tables & Table Shells: Automatically generated placeholder tables with format and footnote logic, enabling early layout sign-off and fewer iteration cycles.
• ADaM / SDTM Datasets: The platform integrates your existing systematic approach with CDISC standards and produces SAS code for ADaM and SDTM datasets.
• TFL Programming (Tables, Figures & Listings): Automated SAS code production and review, replacing double programming with AI agent-driven verification for significant time savings.
• Clinical Study Report (CSR): Automatically merges TFL outputs, narrative text modules, and references to produce a fully formatted CSR draft in hours rather than days.
• Request for Proposals (RFP): AI analyses historical project data, calculates effort, and generates proposal sections, enabling accurate budget estimates and faster proposal management.

How DATAN Analytics AI+ Works

1. A joint analysis of your specific challenge is conducted — identifying which processes to simplify, what type of automation is needed, and where speed improvements are most valuable.
2. You provide your existing templates, examples, and other foundational materials.
3. The most suitable AI model is automatically selected in the background based on the specific task requirements.
4. A prototype agent is developed and iteratively refined together with your team until it fully meets your requirements.
5. You receive your own dedicated agent, enabling you to independently handle routine tasks with substantially reduced effort going forward.
6. In addition to task-specific agents, a general-purpose proprietary AI chat function is available, offering capabilities comparable to commercial AI systems — but within your own secure, protected environment.

Security & Compliance

• Data hosted in ISO 27001-, NISG-, and EN50600-VK3-certified EU data centres
• Data encryption both at rest and in transit
• Role-based access and permissions framework, 21 CFR Part 11 ready
• Complete audit logs for full traceability
• Redundant power supply, cooling, and UPS systems for maximum availability
• Data centres powered by 100% renewable hydroelectric energy
• Optional on-premise installation available for organisations with additional data sovereignty requirements

AI Models & Pricing

• Utilises generative large language models including multimodal (vision-capable) models comparable to ChatGPT
• Virtually all proprietary and open-source models can be integrated as agents via API
• Model selection is handled automatically in the background — no user configuration required
• Pricing is based on the number of users and the number of AI agents deployed
• Onboarding typically begins within a few weeks once the first agent prototype is ready

DATAN Analytics AI+ is suitable for deployment both as a cloud-hosted solution within certified EU infrastructure and as an on-premise installation. The platform is designed to integrate with your existing templates and workflows, and personal onboarding support is provided directly by the DATAN team, with demos available on request.