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왜 ‘용어’를 주목해야 하는가? 임상시험의 세계에서 용어는 단순한 단어의 차원이 아닙니다. 그것은 규제 당국의 시각과 산업의 방향성을 드러내는 중요한 ‘신호’입니다. 이번 ICH E6(R3)의 주요 변화는 현재 임상시험 업계의 전환을 암시하고 있습니다. 그동안 R2에서는 절차와 문서 중심의 규정이 강조됐다면, R3는 목적과 설계 기반, 그리고 데이터 흐름에 대한 통제와 투명성으로 초점이 옮겨지고 있습니다. … ICH E6(R2) → (R3). 바뀐 용어 속에 담긴 규제의 시선
전향적 레지스트리 기반 무작위 임상시험 (Registry-based Randomized Clinical Trial, RRCT)은 일반적으로 기존 환자등록 (registry)을 모집틀로 삼고, 환자를 무작위배정(randomization)합니다. 전자의무기록 (EMR)과 건강보험 데이터베이스 등 대규모 실제 의료현장 (real-world) 데이터를 통합적으로 이용하여 배정된 환자의 장기적 경과 (outcomes)를 추적 평가하는 혁신적 임상시험 방법입니다. 최초의 RRCT 임상연구는 스웨덴에서 급성 심근경색 환자를 대상으로 혈전흡입술(thrombus aspiration) 효과를 평가하기 위해 시행된 … RRCT: 진료현장에서 바로 실행하는 임상시험, 레지스트리 기반 무작위 임상시험
Symyoo, a leading full-service CRO with over 15 years of experience in clinical development, is participating in Bio Korea 2025. The company brings extensive expertise conducting over 250 clinical studies across more than 30 therapeutic areas, including oncology, rare diseases, neurology, and infectious diseases. Notably, two-thirds of Symyoo’s clinical trials have been registrational studies, highlighting … SYMYOO to Showcase Clinical Research Excellence at Bio Korea 2025
SYMYOO, a full service CRO and digital healthcare technology company, has officially announced the launch of Phase 1 of its SYNeRA™️ Clinical Trial Management System (CTMS). This release marks a significant step toward streamlining clinical trial operations and ensuring high-quality data through an integrated digital solution, setting a new standard for clinical trial digitization. All-in-one, … SYMYOO Officially Launches Phase 1 of Its Next-Generation Clinical Trial Management System (CTMS)
SYMYOO was selected as CRO for iTARGET-Elderly Study, a large-scale registry-based randomized controlled trial (RRCT) led by the Korean Diabetes Association (KDA). This study will compare and evaluate moderate-intensity statin therapy with an individualized LDL-C target-based therapy for the primary prevention effects of cardiovascular events in elderly patients with type 2 diabetes. The large-scale study … SYMYOO Selected as CRO for the Large-Scale RRCT “iTARGET-Elderly Study”
SYMYOO is on track to become the most digitalized CRO by integrating advanced IT solutions into its home-grown EDC/ Clinical Trial Management System, in order to streamline patient recruitment and to boost trial efficiency. By combining proprietary digital systems with expert personnel, Symyoo has successfully launched the Man-Unmanned Teaming Clinical Trial (MUM-T CT) model, driving innovation … SYMYOO, Leading the Way in Digitalized Clinical Research
As a National Coordination Center, SYMYOO conducts REMATCH study, which is a very large-scale Registry-based Randomized Clinical Trial (RRCT) sponsored by the Korea Diabetes Association (KDA). This REMATCH study aims to define optimal type 2 diabetes management strategies that will improve cardiovascular and renal outcomes in type 2 diabetes mellitus patient population. Over 60 clinical … SYMYOO Supports Korea Diabetes Association (KDA)’s large-scale RRCT, REMATCH
Smart Trial Research Center (STRC) at SYMYOO launches a new database engine, developed with multi-tier system architecture, meta-data driven and hierarchically structured database design. This SYNeRAᵀᴹ DB engine is optimized considering the systemic structural characteristics that easily reflect various system requirements from simple clinical studies to large-scale, multinational, and multi-center late-stage clinical trials, while enabling … Launch of SYNeRAᵀᴹ Platform DB Engine
Symyoo established Dodlab, Inc., to create new innovations and values under the vision ‘Making the Better Place to Live with IT Technologies’. Dodlab will pioneer new areas in the many industrial sectors, including the healthcare arena, and develop into a leading IT technology company with excellence in technology and expertise in order to help their … Dodlab, an IT Platform Company Launched
Symyoo was designated as a global coordinating center to run late phase multinational clinical trials for Covid-19 medication development. The trials are conducted widely across Korea and European countries. Symyoo understands well that the trial operations should be very specific to the risk and complexity of each region/country where the trials are conducted.