U2CLab 임상시험서비스

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U2CLab 임상시험서비스
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About Us
- 임상연구센터 소개
- 기관생명윤리위원회
Clinical Trial Lab
- 의약품 성능시험
- 건강기능식품 성능시험
IVD Lab
- 임상적 성능시험
- 인체유래물 시험
Notice
- 공지사항
- 뉴스
- 자료실
Contact Us
- 견적문의
- 1:1문의
CLab potal

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About Us
- 임상연구센터 소개
- 기관생명윤리위원회

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Clinical Trial Lab
- 의약품 성능시험
- 건강기능식품 성능시험

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IVD Lab
- 임상적 성능시험
- 인체유래물 시험

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Contact Us
- 견적문의
- 1:1문의
CLab potal

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Service

Clinical Trial Lab!!!!!!

임상시험검체분석의 의약품 성능시험 및
다양한 특수검사 분석을 통한 건강기능식품 성능시험 수행

의약품 성능시험

의약품의 식품의약품안전처 인허가를 위한 임상시험검체분석을 수행

건강기능식품 성능시험

인체에 유용한 기능을 가진 원료ㆍ성분을 사용한 건강기능식품의 성능시험 수행

의약품 성능시험

의약품의 식품의약품안전처 인허가를 위한
임상시험검체분석을 수행

건강기능식품 성능시험

인체에 유용한 기능을 가진 원료ㆍ성분을 사용한
건강기능식품의 성능시험 수행

Service

IVD Lab

인체유래물을 이용하여 체외진단의료기기의 식품의약품안전처 인허가를 위한
체계적인 시스템을 구축하여 신뢰도 높은 인체유래물 연구 수행

임상적 성능시험

체외진단의료기기의 성능을 검증하기 위해
임상검체를 분석하여 임상적ㆍ생리적ㆍ병리학적 결과를 확인하는 시험

인체유래물 시험

체외진단의료기기의 안전성 및 유효성을 인체유래물로 확인하는 시험

임상적 성능시험

체외진단의료기기의 성능을 검증하기 위해
임상검체를 분석하여 임상적ㆍ생리적ㆍ병리학적
결과를 확인하는 시험

인체유래물 시험

체외진단의료기기의 안전성 및 유효성을
인체유래물로 확인하는 시험

Experiences

임상연구센터는 다년간의 임상적 성능시험 및 검체 분석의
경험을 바탕으로 다양한 업무 역량과 데이터를 보유하고 있습니다.

임상연구센터

Clinical Research Center Operation

기관생명윤리위원회(IRB)

Institutional Review Board

Certificate

임상연구센터는 업무의 전문성과 다양한 성능시험의 정확한 결과 도출을 위해 노력합니다.

Fast, Accurate

U2CLab Clinical
Research Center

유투의료재단 임상연구센터는 빠르고 정확합니다.

News

임상연구센터의 새로운 소식을 만나보세요.

Learn More

08

2024. 11

U2CLab 홈페이지가 오픈하였습니다.
05

2024. 09

유투의료재단, 우수포스터상 수상 (2024년 대한임상병리사 종합학술대회 및 국제 컨퍼런스)

유투의료재단은 지난 8월 30일부터 31일까지 인천 송도 컨벤시아에서 진행된
“2024년 제 62회 대한임상병리사 종합학술대회 및 국제 컨퍼런스”에서 우수포스터상을 수상하였습니다.

이번 학술대회에서는 총 4개의 포스터 및 초록을 게재하였고,
그 중 “RPR 검사의 위양성과 신뢰성 향상 방안”과 ”수탁 검사실에서의 대적혈구증(Macrocytosis)의 발생빈도와 평균기온에 따른 변화”로 수상하였습니다.

이번 수상은 그동안 수탁 검사기관으로써 검사결과의 신뢰성을 높이기 위해 노력한 유투의료재단의 성과의 일환입니다.
앞으로도 고객들이 신뢰할 수 있는, 정확한 검사결과를 제공할 수 있도록 노력하는 유투의료재단이 되겠습니다.
23

2024. 05

의료법인 유투의료재단, 임상시험검체분석기관 지정

임상시험검체분석기관은 임상시험 대상자로부터 수집된 임상 검체에 대한 검체분석시험을 실시하는 기관입니다.

『약사법』, 『의약품 등의 안전에 관한 규칙』, 『임상시험검체분석 관리기준』에 따라 분석시설, 전문인력, 시험물질 및 대조물질 취급시설, 검체보관실, 자료보관실 등의 시설 및 인력을 갖추고 식품의약품안전처의 현장실사를 거쳐 식약처장이 지정하게 되며, 임상시험에 필요한 검체분석은 식약처장이 지정한 검체분석기관을 통해 실시되어야 합니다.

의료법인 유투의료재단은 관련 법령의 기준을 충족하여 지난 2024년 05월 03일 식품의약품안전처로부터 제 213 호 “임상시험검체분석기관”으로 지정받았습니다.

임상시험검체분석기관 지정에 따라 임상화학, 진단면역, 혈액학, 요화학 등의 임상검사 항목뿐 아니라 ELISA, Flow cytometry 등의 특수 면역분석 및 DNA, RNA의 핵산분석을 통해 정확하고 신뢰성 있는 분석시험 결과를 제공할 수 있게 되었습니다.

의료법인 유투의료재단은 기존에 보유하고 있던 업무 경험과 노하우를 바탕으로 "의약품 성능시험"의 검체분석 질을 높여 정확하고 혁신적인 의료서비스를 제공하는 전문기관으로 한단계 더 성장할 것입니다.
02

2024. 01

의료법인장원의료재단, 2023 안양시 유공자 표창수여식 대표 수상

의료법인장원의료재단(U2Labs)이 지난해 12월 29일 안양시청 별관에서 진행된 2023 안양시 유공자 표창수여식에서 대표로 표창을 수상했다.

안양시는 매년 이웃사랑을 실천해 사회의 귀감이 되는 자원봉사자, 후원자, 단체를 선정해 유공자 표창을 수여하고 있는 가운데 이날 최대호 안양시장은 의료법인장원의료재단의 허성철 이사장에게 대표로 표창을 수여했다.

의료법인장원의료재단은 안양시와 함께 코로나19 대응체계에 협력하며, PCR진단검사, 원스톱코로나 어플 업무협력 등으로 코로나 위기사항을 극복한 공로를 인정받아 2023 안양시 유공자 표창수여식을 수상한 것이라고 밝혔다.

이밖에 의료법인장원의료재단은 선별진료소를 비롯해 안양시 범계평화공원과 동안구보건소 앞마당에서 임시선별진료소를 운영하며 신속하게 감염병 확산을 차단한 바 있다.

의료법인장원의료재단의 허성철 이사장은 수상 소감을 통해 “앞으로도 기관과의 협력을 통해 적극적인 의료서비스 제공, 신속한 감염병대응체계 구축으로 의료재단으로서의 사회적 책임을 다하겠다”고 소감을 전했다.

[출처] 의료법인장원의료재단, 2023 안양시 유공자 표창수여식 대표 수상 - 아시아투데이 (asiatoday.co.kr)

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