Overview
Company Overview
RealTrial Co., Ltd.
RealTrial is a South Korean clinical development company combining AI decision support with CRO services. Its BioPredictX platform analyzes drug properties and clinical trial designs to estimate success probability, explain key risks, and suggest design alternatives. The company also offers regulatory document support, clinical operations, and electronic data management. RealTrial focuses on emerging biotech and medical device companies and seeks research, service, and investment partnerships.
Address
Website
Class
Medical TechnologyType
Medical ServiceIndications
-Partnering Goals
- Biotech and pharma partners for AI-assisted trial design and CRO services
- Clinical data and research partners for model validation and federated learning
- Seed investors and international CRO partners for commercial expansion
Investment Info
Shareholders
Funding Goal
Seeking approximately USD 230K in seed funding in Q4 2026 at a pre-money valuation of USD 2.3 million. Planned allocation: 40% for AI and data, 40% for key personnel, and 20% for quality systems and external validation. The 18-month plan focuses on converting analytical engagements into CRO contracts and improving delivery profitability.
Team
Key People
SeungYoung Choi
- Master's degree in Pharmacy, Seoul National University. - Over 20 years of clinical development experience across global CROs and biotech companies. - Established Tigermed's Korean operation and participated in the DreamCIS acquisition. - Project Management Professional (PMP) certification.
Kyung-Sik Park
- Over 10 years of experience leading bio/medical full-stack platform development. - Led government-funded AI R&D and medical data structuring. - Built in-house EDC and DCT platform architectures.
Hyun-Sook Baek
- Master's degree in Public Health, Seoul National University. - Oversees MFDS and FDA clinical regulatory submissions, including IND activities. - Leads regulatory preparation and decentralized trial operations.
Se-Geun Park
- Master's degree in Molecular Biology, Wonkwang University. - Over 21 years of business development experience, including AI drug discovery platforms. - Leads sponsor engagement, clinical service proposals, and partnerships.
Advisors
Private
Tech & Products
Technology Details
BioPredictX: Molecular and Trial Design Analysis
The company reports a clinical-success model built from 11,115 trials and 295 features, including 125 molecular values. Internal evaluation achieved an AUROC of 0.801, with SHAP explanations and similar-trial comparisons supporting interpretation. External evaluation is planned for 2027.
RA Submission Builder: Regulatory Readiness
RA Submission Builder checks required documents and information gaps, then supports draft preparation for regulatory review. The service links submission preparation with clinical and regulatory consulting.
RealTrial CRO: Clinical Execution
RealTrial provides clinical operations, regulatory affairs, medical writing, data management, and biostatistics. Its service scope covers drug trials, investigator-initiated and observational studies, post-marketing surveillance, and medical device studies.
EDC Infrastructure and Federated Learning R&D
RealTrial offers electronic data capture setup, data management, and analysis-dataset support, backed by in-house EDC and decentralized trial architecture. A separate R&D project with Gachon University is developing federated learning to use data across institutions while limiting raw-data transfer.
Problem & Unmet Needs
Clinical Design Risks Identified Too Late
Poorly matched patient populations, endpoints, and recruitment assumptions can undermine a trial after major spending has begun. Sponsors need earlier, evidence-based comparisons of design alternatives to identify avoidable risks.
Fragmented Development Workflows
Drug assessment, protocol planning, regulatory documents, and trial operations often involve separate teams and systems. Emerging biotech companies need coordinated support to turn analytical findings into executable development plans.
Market Trends
AI Adoption in Trial Planning
AI is increasingly used for trial outcome prediction, protocol optimization, and study simulation. Recent offerings from major CROs and specialist vendors show growing commercial activity around earlier, data-informed development decisions.
Automation of Regulatory Workflows
Generative AI and structured authoring tools are expanding into regulatory and medical writing. These tools connect source evidence with document preparation and expert review.
Competitive Landscape
Global CROs with AI Capabilities
Large CROs such as IQVIA and ICON are expanding predictive and protocol-design AI capabilities alongside trial delivery. RealTrial focuses on emerging biotech sponsors through initial analytical services linked to regulatory support and CRO execution.
Specialist Clinical AI and Regulatory Software
QuantHealth provides clinical simulation and protocol optimization, while Certara CoAuthor supports AI-assisted regulatory writing. RealTrial combines related decision-support and documentation functions with its own CRO service offering.
Pipeline
Pipeline
BioPredictX - Clinical Success Prediction and Trial Design
Current Stage
Initial CommercializationPatents & Papers
Papers
Private
Patents
Patent Title
Method and System for Calculating Drug-Property Contributions Using Explainable AI Analysis and Generating a Clinical Trial Protocol Based Thereon
Status
Filed
Application Year
2026
Application Countries
KR
Patent Title
AI-Based Platform and Method for Integrated Management of Drug Development Prediction and Clinical Trial Operations
Status
Filed
Application Year
2026
Application Countries
KR
Patent Title
AI-Based System for Learning Drug Structure and Clinical Design Correlations, and Systems and Methods for Predicting Clinical Success and Optimizing Clinical Design
Status
Filed
Application Year
2026
Application Countries
KR
Certifications
Private
