Our Services
How We Support Your Clinical Development
Clinical Development Strategy
임상개발 전략 수립 및 임상시험 설계 Strategic clinical development planning, study design, and protocol development tailored to product characteristics and regulatory requirements.
Regulatory Affairs
식약처 인허가 및 IRB 심의 대응
Regulatory support for MFDS submissions, IRB reviews, and preparation of clinical trial approval documents.
Project Management
임상시험 프로젝트 일정, 예산 및 품질 관리 Comprehensive clinical trial project management, including study timelines, budgets, resource coordination, and quality oversight.
Site Management & Monitoring
연구기관 관리 및 임상시험 모니터링
Clinical site management, study coordination, monitoring, and oversight of protocol compliance and data quality.
Data Management
임상시험 데이터 수집 및 품질 관리
Clinical data collection, CRF/eCRF development, data validation, query management, and database quality control.
Biostatistics
임상시험 표본수 산출 및 통계 분석
Sample size calculation, statistical analysis planning, clinical data analysis, and interpretation of study results.
Medical Writing
임상시험계획서 및 임상시험 결과보고서 작성
Preparation of clinical trial protocols, regulatory documents, clinical study reports, and other essential clinical documents.
Post-Market Clinical Research
시판 후 임상연구 및 안전성·유효성 평가
Post-market clinical study planning, safety and effectiveness evaluation, and generation of real-world clinical evidence.
Clinical Experience &
Track Record
