What Trial Informatics does

Trial Informatics (트라이얼인포매틱스) is a Seoul-headquartered data science company founded in January 2021 as a spin-off from Asan Medical Center, specializing in clinical trial data management and digital health technology platforms. The company builds and sells six integrated CDISC-compliant software products: ImageTrial (clinical trial imaging management with RECIST-based tumor response assessment), OncoTrial Board (web-based precision medicine visualization and medical monitoring), TrialDataHub (data integration warehouse), BOIM (clinical trial operations management), CsafeR (AI-assisted safety database for adverse event reporting), and CTMS (clinical trial management system). These platforms run on a cloud-based web architecture and target pharmaceutical companies, biotech ventures, and contract research organizations (CROs) across Korea, the US, and Singapore. C&R Research, a Korean CRO, is the parent company and second-largest shareholder, providing both distribution and a captive customer base.

The company generates revenue through enterprise subscription licensing of its software platforms (quote-based annual billing) and professional services including clinical trial consulting, Safety Review Meeting and IDMC services, and independent imaging review. Go-to-market is primarily enterprise field sales supported by conference participation (ASCO, RSNA, KOREA LIFE SCIENCE WEEK), webinars, and channel partnerships — most notably Cytel for IDMC services to Korean pharma and a Microsoft technology collaboration signed in June 2024. The company holds HIPAA, ISO/IEC 27001, ISO 27799, and ISO 9001 certifications, enabling US and global enterprise sales. It also operates a Singapore subsidiary (established September 2022), a Boston branch (December 2023), and an AI-image-recognition subsidiary called TI Image (November 2024). AI capability is featured rather than foundational, applied to safety reporting automation (CsafeR), imaging workflow automation (ImageTrial), and NPU-based diagnostics via a SAPEON Korea collaboration.

Name

Trial Informatics

Legal name

주식회사 트라이얼인포매틱스 (Trial Informatics Co., Ltd.)

Website

https://trialinformatics.com

Company type

Private

Founded year

2021

Operating status

Operating

Headcount range

11–50 employees

Short description

Trial Informatics is a Seoul-based data science company (founded 2021, spin-off from Asan Medical Center) that builds CDISC-compliant clinical trial data and imaging platforms — ImageTrial, OncoTrial Board, TrialDataHub, CsafeR, BOIM, and CTMS — sold via enterprise subscriptions to pharmaceutical companies, biotech firms, and CROs across Korea, the US, and Singapore.

Ownership category

akta.pro rank

Product category

Clinical Trial Data Management Software

NAICS

Scientific Research and Development Services (5417), Other Scientific and Technical Consulting Services (54169)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Clinical Trial Informatics (EDC/CTMS/eCOA/eTMF) (HLAGAJAM)

akta.pro secondary industries

Clinical Trial Analytics, Risk-Based Monitoring (RBM) & Quality Management (HLACAOAI), Precision Clinical Trials Enablement (patient matching, site matching, adaptive trials) (HLAAANAI)

Keywords

• Clinical trial data management
• Clinical trial imaging software
• CDISC-compliant platforms
• Pharmacovigilance safety database
• Precision medicine data analytics

Headquarters

HQ city

Seoul

HQ country

South Korea

HQ region

Asia

Offices3 records

Markets served

GTM type

B2B

Offering type

Software

Cost components

Personnel, Technology or R&D, Infrastructure, Operations, Marketing or Sales

Revenue model

1. Software Platform Subscriptions: Subscription-based access to clinical trial IT platforms including ImageTrial, OncoTrial Board, Trial DataHub, CsafeR, BOIM, and CTMS for pharmaceutical companies, biotech ventures, and CROs.
2. Clinical Trial Consulting Services: Medical and scientific consulting including Target Product Profile development, clinical trial design, regulatory approval strategy, and medical monitoring services.
3. Safety Review and IDMC Services: Safety Review Meeting and Independent Data Monitoring Committee services using IT solution-based platforms.
4. Independent Imaging Review Services: Independent read services for clinical trial imaging data management.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels5 records

Core offering

Trial Informatics is a data science company that develops and sells an integrated clinical trial IT and data platform composed of six core software products: ImageTrial (CDISC-compliant imaging management), TrialDataHub (clinical data warehouse), OncoTrial Board (precision medicine visualization and medical monitoring), BOIM (clinical trial operations), CsafeR (AI-assisted safety database), and CTMS (clinical trial management system). The company also provides medical and scientific consulting services including clinical trial design, regulatory approval strategy, safety review/IDMC services, and independent imaging review. Customers are pharmaceutical companies, biotech ventures, CROs, and academic medical centers.

Product overview

Trial Informatics provides an integrated clinical trial IT and data platform composed of six core products: ImageTrial (CDISC-compliant imaging management), TrialDataHub (data integration warehouse), OncoTrial Board (visualization and medical monitoring), BOIM (clinical trial management), CsafeR (AI-assisted safety database), and CTMS (trial management system). The platform follows international standards including CDISC and supports the full clinical trial data lifecycle from imaging to safety reporting.

Differentiator

Problem solved

Functional benefit

Brands

• OncoTrial Board: Web-based platform for clinical trial data visualization, medical monitoring, and multidisciplinary tumor consultation for clinical trials.
• ImageTrial
• TrialDataHub (TDH)
• CsafeR
• CTMS
• BOIM

Products and services

• ImageTrial CDISC-compliant clinical trial imaging management system with automatic verification and data transformation modules enabling RECIST-based tumor response assessment, independent read, image data management, and data warehousing. Designed for pharmaceutical companies, biotech ventures, and CROs conducting imaging-intensive oncology and other clinical trials.
• TrialDataHub (TDH) Next-generation integrated data management platform (data warehouse) for consolidating clinical trial data, with real-time data analysis and visualization. Supports Safety Review Committee, Independent Data Monitoring Committee (IDMC), and online medical monitoring services for sponsors and CROs.
• OncoTrial Board (OTB) Web-based precision medicine platform for clinical trial data visualization, medical monitoring, and multidisciplinary tumor board. Enables real-time Q&A with experts and allows pharmaceutical companies to reuse accumulated data for additional clinical trials or drug development.
• BOIM Best Operational solution for innovative clinical trial management with user-friendly UX/UI, strong data integrity assurance, smart clinical trial operations, and optimized workflow for improved productivity.
• CsafeR AI-assisted Safety Database that streamlines adverse event reporting and management, including SAEs, with flexible and compliant E2B data submission and time-driven reporting. Ensures regulatory compliance and enhanced patient safety throughout clinical trials.
• CTMS Unified Clinical Trial Management System ensuring standardized operations, regulatory readiness, and operational efficiency, with template-driven expansion for global trials.
• Medical & Scientific Consulting Services Professional consulting including Target Product Profile development, clinical trial design, regulatory approval strategy, and medical monitoring services, delivered alongside the software platforms to pharmaceutical, biotech, and CRO customers.
• Safety Review & IDMC Services Safety Review Meeting and Independent Data Monitoring Committee (IDMC) services delivered using Trial Informatics' IT platforms (TrialDataHub, OncoTrial Board), provided to Korean pharmaceutical companies in partnership with Cytel.
• Independent Imaging Review Services Independent imaging read services for clinical trial imaging data management, leveraging ImageTrial and Trial Informatics' radiologist network for RECIST-based assessments.

Quantifiable outcome

• Zero human input errors achieved in CDISC-compliant CTIMS validation vs. 176 errors in previous system
• +2 more outcomes

Named customers4 records

Segments4 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability4 records

Feature6 records

Partnerships

Eight partnerships are on record, tiered major and core.

• MicrosoftmajorTechnology or Integration · 1 June 2024MOU with Microsoft signed in June 2024 for technology collaboration, representing a significant partnership with a major technology provider.
• Amazon Web Services (AWS)coreTechnology or Integration · 1 May 2023AWS is used as the cloud infrastructure for data storage, providing service data storage including clinical and member information. AWS infrastructure is hosted in Tokyo, Japan for data processing and storage services.
• CytelcoreStrategic or Co-development Partner · 28 October 2022Partnership with US-based Cytel for providing Independent Data Monitoring Committee (IDMC) services to Korean pharmaceutical companies. Trial Informatics uses its OncoTrial Board solution to provide efficient and safe monitoring in compliance with global regulations. Collaboration includes domestic marketing and customer management for IDMC services.
• Korean Cancer Study Group (KCSG) / Korean Society of Medical OncologycoreStrategic or Co-development Partner · 23 May 2022MOU for clinical trial data-based precision medicine research advancement. Collaboration areas include OncoTrial Board platform for digital transformation, multidimensional clinical trial data visualization with CDISC standards, advanced technology exchange for multi-institutional cancer clinical trial data management, and technology exchange for safe and effective cancer treatment development.
• Asan Medical Center (Seoul National University)coreStrategic or Co-development Partner · 10 November 2021Trial Informatics was spun off from Asan Medical Center in January 2021. The company is located at Asan Medical Center's education research building and participates in the Bio Core Facility Center (CHOICE program) for biotech startup support. Kim Kyung-won, CEO, is a professor at Asan Medical Center's Radiology Department.
• Pharm cello BIO (박셀바이오)coreStrategic or Co-development Partner · 1 July 2021MOU for precision medicine research collaboration focused on hepatocellular carcinoma treatment using Vax-NK/HCC. Collaboration areas include OncoTrial Board platform for clinical information digital transformation, patient-centered digital data visualization with CDISC standards, and advanced technology exchange for anticancer immunotherapy clinical data management and analysis.
• TI ImagecoreOthersTI Image is a subsidiary/affiliate company of Trial Informatics. CEO Byung In Yoon serves as CEO of both Trial Informatics (since May 2024) and TI Image (since November 2024). TI Image participates jointly with Trial Informatics at conferences such as ASCO 2026.
• KoNECT (Korea National Enterprise for Clinical Trials)majorOthersTrial Informatics collaborates with KoNECT for education and professional development, including hosting RECIST-based independent imaging review training programs for radiologists and oncologists. The company has participated in KoNECT-MOHW-MFDS International Conference exhibitions.

Scale indicators5 records

Recent moves8 records

Expansion highlights5 records

Direct peers

• Veeva Systems: Provider of Vault CTMS, Vault EDC, and Vault eTMF for life sciences. Direct competitor to Trial Informatics' CTMS and trial data management offerings, particularly in pharma enterprise accounts.
• Clario: Specializes in clinical trial imaging endpoints, eCOA, and decentralized trial technology. Direct competitor to ImageTrial's RECIST-based tumor response assessment and OncoTrial Board's medical imaging workflows.
• Calyx: Offers RIM, CTMS, EDC, RTSM, and imaging management for clinical trials. Direct competitor across Trial Informatics' data management and imaging portfolio, particularly for biotech sponsors.
• Medrio: Cloud-native EDC, ePRO, and eConsent platform for clinical trials. Competes with Trial Informatics' data capture and BOIM operational modules, especially in small-to-mid biotech.
• RealTime Software Solutions: Site-focused CTMS, eDOCS, and eSource for clinical research sites and CROs. Direct competitor to Trial Informatics' CTMS and BOIM for site operations and SMO workflows.

Broad incumbents

• Medidata (Oracle Health Sciences): Industry-leading Rave EDC, Rave Imaging, CTMS, and eCOA suite. Operates as a broad incumbent with overlapping CTMS, imaging management, and trial data capabilities that compete across Trial Informatics' product set.
• ArisGlobal: LifeSphere platform covering safety (pharmacovigilance), regulatory, CTMS, and EDC. Overlaps with Trial Informatics' CsafeR safety database and CTMS, particularly for mid-market pharma.
• Advarra: Provides CTMS, IRB, and eRegulatory solutions for clinical research sites and sponsors. Overlaps with Trial Informatics' CTMS and regulatory-grade data management offerings.

Emerging players

• Castor: Cloud EDC and decentralized trial platform with strong biotech and academic adoption. Emerging competitor in the same clinical trial data management category, particularly for early-phase and academic trials.

Others

• Cytel: Statistical and clinical trial services firm that is both a partner (IDMC services) and adjacent player. Comparable as a clinical trial services ecosystem participant but not a direct software platform competitor.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Subsidiaries2 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Trial Informatics