Manual documentation stalls clinical innovation.
The $63 B Clinical Trial industry is growing, yet manual documentation processing creates a multi-billion dollar bottleneck
70%
Manual Document Processing
6 M Regulatory Documents are produced yearly, yet the majority are still handled manually with traditional tools like Excel.
$1.8 B
Cost of Manual Work
Highly qualified regulatory experts are tied down by repetitive data-entry tasks rather than focusing on high-level work.
42%
of all Deficiencies are Document-Related
During compliance audits by European Medical Agency 42% of all discovered deficiences were document-related.
12B
Lost Commercial Value
These inefficiencies stall the regulatory approvals of life-saving drugs and their delivery to patients
Scale CROs Revenue, Not Paperwork
By automating 70% of document work, we help CRO stay on budget, hit sponsor deadlines and increase trial volumes.
70%
Efficiency Gain
Automation dramatically cuts document preparation time allowing regulatory teams to focus on high-level review, approval and compliance.
25M
Hours of Manual Work Reclaimed
if we cut document preparation by 20 days. By shortening trial timelines, we help CROs scale their trial portfolios
50 Days
Avoidable Delay
Automation can save around 20 days for document preparation + 30 days caused by regulator's RFIs following a document inconsistency
$540K
Daily Value Recovery
Each day of trial delay means $40K of direct costs to CROs and $0.5M in lost revenue to pharma sponsors
Al-Powered Platform Automating Regulatory Submissions
Sponsor Data Check
AI checks the sponsor's data to ensure it's consistent and error-free. Any errors and issues are flagged.
One-Click Generation
AI generates ready-to- review submission packages for each country where a clinical trial is carried out
Compliance and multi-country localisation
AI ensures compliance with national and other regulations (e.g. CTIS)
Modifications Handling
AI implements modifications consistently and errof-free across all affected trial documents.
Trial Central Management Dashboard
A user-friendly dashboard to manage all ongoing clinical trials. Eliminate the chaos of scattered applications and version control errors.
Intelligent Search
Enables instatnt search of current and historical clinical data. No need to spend hours for manual search through separate folders and applications.
powered by AI
Security & Human Control
Protect your trial integrity with GDPR-compliant hosting and human-in-the-loop oversight, allowing you to grow your portfolio without sacrificing quality.
Human-in-the-Loop
CRO regulatory teams are in control of every submission
Regulatory team keeps track of every submission and performs final sign-offs. This enables 100% compliant and high-quality submissions.
Data Security and Privacy
Sovereign Infrastructure Built for Global Standards and sensitive data
The clinical data is securely stored on our secure German cloud or on customer's own servers. Whether you need a private setup or custom infrastructure, we ensure the data stays under your control and audit-ready. The platform is fully compliant with GDPR (DSVGO).
Our Team of Experts
Pavel Sagulenko
CEO and Founder
PhD from Max-Plank Insitute with 15+ years in AI, biotech, science. Track record of leading teams, creating production-ready AI systems, full stack development, MLOps and infrastructure architerchture
Anna Hebenstreit
Compliance and Legal
Master in Law from the London School of Economics and Political Science.
Corporate Lawyer with 15 + years of legal and compliance expereience in UK and Germany. Oversees legal compliance, operational excellence, and corporate governance to ensure seamless execution and compliance.
Corporate Lawyer with 15 + years of legal and compliance expereience in UK and Germany. Oversees legal compliance, operational excellence, and corporate governance to ensure seamless execution and compliance.
Ilya Billig
Sales Director
Former Business Development and Marketing Director at Microsoft, Hitachi, and Intel across USA and EMEA. 10 years building startups in the USA, followed by 10 years leading sales teams for complex industrial AI implementations.
Validated by Enterprise Clients
Real-world AI implementations supporting regulated enterprises in improving operational efficiency, ensuring compliance, and maintaining accuracy across complex, mission-critical workflows.
Renewable Energy Company based in Munich
A custom Three-Agent RAG System including:
- Grant & Application Assistant | Produces accurate funding applications.
- Knowledge Base Agent | Enables smart search and instant data retrieval across all internal company data.
- Technical Writing Assistant | Generates compliant reports and manuals using templates.
Result: 70% reduction in writing cycles and the total elimination of manual „copy-paste“ errors.
Pharma Company based in Munich
A custom Knowledge Base Assistant for over 10 TB of clinical, research and CMC data scattered across three systems, enabling:
- Protocol & Version Control | Tracking current and historical clinical trial protocols and modifications.
- Instant Search & History | Retrieval of company records from various applications.
Result: Accelerated clinical workflows through instant data access eliminating duplicate work.
Common Questions
Does your platform support clinical trials in any country?
Our platform is currently supporting submission in EU under CTIS and EU national legislation. It can be expanded to other countries on customer's demand.
What is your business and pricing model?
Our pricing is based on on the number of users and trials. Contact us to discuss your needs and pricing.
What makes your platform different from competition?
Unlike established e-clinical providers who offer generic clinical trial tools, our core focus is the generation of regulatory document packages compliant with CTIS and EU national laws.
Another key advantage of our platform is that it implements modifications across all relevant documents, consistently and error-free.
Unlike SaaS competitors who use public clouds, we offer a private German-hosted infrastructure or direct installation on your own servers. This ensures your sensitive trial data stays under your control.
Are you compliant with GDPR and EU AI Act?
The Platform is fully compliant with GDPR and EU AI Act.