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、SUNPharma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。ClinicalResearchCenterofJinanCentralHospitalAffiliatedtoShandongFirstMedicalUniversityJinancentralhospitalaffiliatedtoShandongFirstMedicalUniversity,locatedatJinanCity,ShandongProvince,China,isacomprehensivehospitalestablishedin1958withthecapacity2000beds.TheclinicalresearchcenterofJinancentralhospitalhadpassedthequalificationcertificationoftheChinaFoodandDrugAdministration(CFDA)firstlyonJanuary20,2010,andthenpassedregularre-inspectionsin2013and2017,alongwiththeadditionalcertificationofnewspecialties.Sofartherearetwentyqualifiedspecialtieseligibletoundertaketheclinicaltrialsofdrugs:cardiovascular,respiratorymedicine,neurology,endocrinologyandmetabolism,hematology,gastroenterology,oncology,burn,dermatology,nephrology,anesthesiology,thoracicsurgeryandepidemiology,aswellastheclinicaltrialresearchcenterforPhaseI.Andthespecialtiesqualifiedforclinicaltrialsofinstrumentsanddiagnosticreagentsare:cardiovascular,respiratorymedicine,neurology,endocrinologyandmetabolism,hematology,gastroenterology,nephrology,oncology,burn,thoracicsurgery,orthopedics,gastrointestinalsurgery,hepatobiliarysurgery,vascularsurgery,breastandthyroidsurgery,plasticsurgery,neurosurgery,urology,traditionalChinesemedicine,gynecologyandobstetrics,stomatology,dermatology,anesthesiology,medicalimaging(includingX-raydiagnosis,magneticresonanceimaging,CTdiagnosisandultrasounddiagnosis)andlaboratorymedicine.Theclinicalresearchcenterhasbeenestablishingandimprovingthemanagementsystemsandstandardoperationprocedures(SOPs)instrictcompliancewiththenationallaws,regulationsandguidingprinciples,aswellasrequirementsofICH-GCP.Moreover,theresearchconditionsandabilityoftheclinicalresearchcenterhavebeenimprovingadheringtotheconceptof"scientificmethods,standardizedoperations,soundmanagement,andqualityservice".Theclinicalresearchcenterhadbeenundertakenmorethan400clinicaltrialprojectsinthelastfiveyears,includingleadingfivedomesticmulti-centerprojects,participatinginmorethan60internationalmulti-centerprojects,completingmorethan20earlyclinicalresearchesofinnovativemedicinesandaccomplishingover100clinicaltrialprojectsofbiologicalequivalence(BE)ofgenericdrugs.Inrecentyears,theclinicalresearchcenterhascarriedoutplentyofclinicalresearcheswithforeignpharmaceuticalcompaniesincludingSanofi,NovoNordisk,AstraZeneca,GlaxoSmithKline,MerckSharp&Dohme,Roche,BoehringerIngelheim,SUNPharma,Sandoz,EliLilly,etc.,aswellasdomesticpharmaceuticalcompaniesincludingQiluPharmaceutical,JiangsuHengrui,Simcere,Innovent,TopAllianceandZhengdaTianqing,etc.,andCROcompaniesincludingQuintiles,Covance,Parexel,ICON,Tiger,etc.,establishinggreatcustomerrelationshipsandindustryreputation.Additionally,overtwentyclinicaltrialprojectsofclinicalresearchcenterhavepassedon-siteinspectionbytheNMPAwithoutmajorfindinginthepastthreeyears.