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临床研究中心

临床研究中心简介

山东第一医科大学附属中心医院

济南临床研究中心

医院建于1958年,是拥有2000张床位的综合性三级甲等医院。临床研究中心于2010年1月20日首次通过国家食品药品监督管理总局(CFDA)的资格认证,2013年、2017年通过了复核检查并新增认证专业,2020年按国家局要求完成机构备案,截至目前,具备承担药物临床试验资格的专业分别是:心血管、呼吸、神经内、内分泌、血液、消化、肿瘤、烧伤、皮肤(皮肤、性病)、肾病、麻醉、胸外、传染科(呼吸道、肝病、肠道)、1期临床研究室;具备承担器械和诊断试剂临床试验资格的专业分别是:心血管、呼吸、神经内、内分泌、血液、消化、肾病、肿瘤、烧伤、胸外科、骨科、胃肠外科、肝胆外科、血管外科、两腺外科、整形外科、神经外科、泌尿外科、中医科、妇产科(妇科、产科)、口腔科、皮肤科、麻醉科、医学影像科(X线诊断、磁共振成像、CT诊断、超声诊断)、医学检验科。

临床研究中心建立和完善了各项管理制度和SOP,严格遵守国家相关法律、法规及指导原则,遵循ICH-GCP的要求,秉承“方法科学、操作规范、管理完善、服务优质”的理念,不断改善研究条件、提高研究水平、保证研究质量。近五年,医院共承接药物临床试验项目400余项,其中牵头国内多中心研究5项,参加国际多中心研究60余项,完成创新药早期临床研究20余项,BE研究100余项。

几年来,与赛诺菲、诺和诺德、礼来、阿斯利康、葛兰素、默沙东、罗氏、山德士、SUN Pharma等外资医药企业,齐鲁制药、江苏恒瑞、先声药业、信达、君实等国内企业以及艾坤纬、Covance、Parexel、泰格等CRO公司合作开展多项临床研究,建立了良好的客户关系和业界口碑。

近三年,先后接受了国家药监局审核查验中心组织的20余个项目的临床试验现场核查,未见真实性问题。

 

Clinical Research Center of Jinan Central Hospital Affiliated to Shandong First Medical University

 

Jinan central hospital affiliated to Shandong First Medical University, located at Jinan City, Shandong Province, China, is a comprehensive hospital established in 1958 with the capacity 2000 beds. The clinical research center of Jinan central hospital had passed the qualification certification of the China Food and Drug Administration (CFDA) firstly on January 20, 2010, and then passed regular re-inspections in 2013 and 2017, along with the additional certification of new specialties. So far there are twenty qualified specialties eligible to undertake the clinical trials of drugs: cardiovascular, respiratory medicine, neurology, endocrinology and metabolism, hematology, gastroenterology, oncology, burn, dermatology, nephrology, anesthesiology, thoracic surgery and epidemiology, as well as the clinical trial research center for Phase I. And the specialties qualified for clinical trials of instruments and diagnostic reagents are: cardiovascular, respiratory medicine, neurology, endocrinology and metabolism, hematology, gastroenterology, nephrology, oncology, burn, thoracic surgery, orthopedics, gastrointestinal surgery, hepatobiliary surgery, vascular surgery, breast and thyroid surgery, plastic surgery, neurosurgery, urology, traditional Chinese medicine, gynecology and obstetrics, stomatology, dermatology, anesthesiology, medical imaging (including X-ray diagnosis, magnetic resonance imaging, CT diagnosis and ultrasound diagnosis) and laboratory medicine.

The clinical research center has been establishing and improving the management systems and standard operation procedures (SOPs) in strict compliance with the national laws, regulations and guiding principles, as well as requirements of ICH-GCP. Moreover, the research conditions and ability of the clinical research center have been improving adhering to the concept of "scientific methods, standardized operations, sound management, and quality service". The clinical research center had been undertaken more than 400 clinical trial projects in the last five years, including leading five domestic multi-center projects, participating in more than 60 international multi-center projects, completing more than 20 early clinical researches of innovative medicines and accomplishing over 100 clinical trial projects of biological equivalence (BE) of generic drugs.

In recent years, the clinical research center has carried out plenty of clinical researches with foreign pharmaceutical companies including Sanofi, Novo Nordisk, AstraZeneca, GlaxoSmithKline, Merck Sharp&Dohme, Roche, Boehringer Ingelheim, SUN Pharma, Sandoz, Eli Lilly, etc., as well as domestic pharmaceutical companies including Qilu Pharmaceutical, Jiangsu Hengrui, Simcere, Innovent, TopAlliance and Zhengda Tianqing, etc., and CRO companies including Quintiles, Covance, Parexel, ICON, Tiger, etc., establishing great customer relationships and industry reputation. Additionally, over twenty clinical trial projects of clinical research center have passed on-site inspection by the NMPA without major finding in the past three years.