C&R Research (씨엔알리서치) was founded in 1997 and is headquartered in Seoul, South Korea, with a regional office in Busan and international offices in Boston (United States), Singapore, Bangkok (Thailand), and Jakarta (Indonesia), established successively between 2023 and 2026. The company employs approximately 500 staff and has completed over 1,800 clinical trials since its founding, including 79 multi-country studies, positioning it as South Korea’s largest and most established domestic CRO.

The company provides a full spectrum of clinical development services across pharmaceutical, biotechnology, and medical device sectors, covering Phase I through Phase IV studies and post-marketing surveillance. C&R Research serves both domestic Korean sponsors seeking international regulatory approvals — primarily FDA and EMA — and international sponsors entering the South Korean and broader Asian clinical development markets. The company’s dual-directional model handles outbound programmes (Korean sponsors going global, with C&R serving as the central CRO) and inbound programmes (overseas sponsors entering Korea, with C&R serving as the local CRO reporting to the central team or global sponsor).

C&R Research operates a group structure encompassing six affiliated entities: TrialInformatics (clinical trial data IT solutions), TI Image (imaging CRO), Mediplexus (real-world data and medical data), CNR SMO (site management organisation), ABC Bioscience (full-cycle drug development consulting), and CNR Healthcare Global (ASEAN clinical operations). In 2025, the company achieved its first multi-country NDA approval and its first FDA medical device IDE approval. In 2026, C&R signed an MOU with Taimei Intelligence R&D and became the first Korean adopter of Taimei’s AI agent platform for clinical trial operations, signalling a stated transition toward AI-enabled and data-driven trial management.

Key Products and Services

Medical Advisory and Consulting

• Drug development strategy — integrated development planning, Phase I statistical package design for IND submission, SAP development, and adaptive study design
• Medical advisor services — physician-led scientific consultation throughout the trial lifecycle, including protocol development, medical issue resolution, and CSR support
• Clinical development strategy optimisation — simulation-based quantitative risk analysis, inter-country data standardisation for multi-regional trials, and regulatory value maximisation through real-world data integration

Early-Phase Clinical Development

• First-in-human study design and execution, Phase I/IIa protocol development, PK/PD assessment, bioequivalence studies, and IND/CTA preparation for FDA, EMA, and MFDS (Korea)
• Pre-IND, IND, and ODD submission support; IB, CTD, and IMPD preparation

Trial Management

• Full-service clinical operations: site identification, feasibility, initiation, monitoring (on-site and remote), and close-out
• Project management including budget, timelines, and risk management
• Site management organisation (SMO) services via the CNR SMO subsidiary

Regulatory Affairs

• Regulatory strategy and submission management for MFDS (Korea), FDA (US), EMA (EU), TFDA (Thailand), CREC (China), and other regional authorities
• Multi-country IND and IDE submissions; orphan drug designation; import licence management; amendment and notification handling

Data Management

• eCRF design and database development, discrepancy management, medical coding (MedDRA and WHO Drug), CDISC compliance (SDTM, ADaM), and database lock
• External data reconciliation and integration; real-world data analysis via Mediplexus subsidiary; AI-enabled data platform via Taimei AI agent integration

Biostatistics

• Statistical analysis plans, sample size calculations, randomisation design, interim and final analyses, and Bayesian statistical methods for adaptive trial designs

Pharmacovigilance

• Adverse event and SAE processing, safety database management, expedited reporting, DSURs/PSURs, and post-marketing surveillance programmes

Quality Management

• QMS development and maintenance, GCP audits, CAPA management, and inspection readiness support to ICH-GCP standards

Imaging Services (via TI Image)

• Clinical trial imaging CRO services, selected as APAC representative imaging CRO in 2024

Therapeutic Area Coverage

Oncology and Haematology (solid tumours, lung cancer, AML, breast cancer, GIST, CML), CNS and Neurology (Alzheimer’s disease, migraine, stroke), Respiratory (COPD, asthma, IPF), Metabolic and Endocrine (NASH/MASH, obesity, type 2 diabetes, hypercholesterolaemia), Infectious Disease (COVID-19, antibiotics, malaria), Immunology (SLE, atopic dermatitis, ulcerative colitis), Ophthalmology (wet AMD), Rare Disease and Other (Cushing’s syndrome, DMD, BMD, Duchenne muscular dystrophy), and Digital Therapeutics (DTx, including the first Korean DTx US FDA confirmatory trial).

C&R Research occupies the leading position among domestic South Korean CROs, with nearly three decades of operational history, 500 employees, and a track record across more than 1,800 trials including a growing portfolio of multi-regional studies. Its strategic significance lies in its role as the primary bridge for Korean biotech and pharma companies pursuing global regulatory approvals — particularly FDA and EMA — at a time when South Korea has emerged as one of the world’s most active clinical trial environments, offering large treatment-naive patient populations, sophisticated investigator networks, and regulatory timelines competitive with Western markets. The company’s establishment of US, Thai, Indonesian, and Singapore offices between 2023 and 2026 reflects a deliberate transition from a Korea-centric model to a regionally anchored Asian CRO with genuine multi-country operational capability. Its group structure — spanning SMO, imaging, real-world data, IT, and consulting subsidiaries — provides a degree of vertical integration unusual for a CRO of its size and reinforces its positioning as an end-to-end development platform rather than a standalone clinical operations provider.