醫院建于 1958 年，是擁有 2000 張床位的綜合性三級甲等醫院。臨床研究中心于 2010年 1月 20日首次通過國家食品藥品監督管理總局（CFDA）的資格認證，2013年、2017年通過了復核檢查并新增認證專業，2020年按國家局要求完成機構備案，截至目前，具備承擔藥物臨床試驗資格的專業分別是：心血管、呼吸、神經內、內分泌、血液、消化、腫瘤、燒傷、皮膚（皮膚、性病）、腎病、麻醉、胸外、傳染科（呼吸道、肝病、腸道）、1期臨床研究室；具備承擔器械和診斷試劑臨床試驗資格的專業分別是：心血管、呼吸、神經內、內分泌、血液、消化、腎病、腫瘤、燒傷、胸外科、骨科、胃腸外科、肝膽外科、血管外科、兩腺外科、整形外科、神經外科、泌尿外科、中醫科、婦產科（婦科、產科）、口腔科、皮膚科、麻醉科、醫學影像科（X線診斷、磁共振成像、CT診斷、超聲診斷）、醫學檢驗科。
臨床研究中心建立和完善了各項管理制度和SOP，嚴格遵守國家相關法律、法規及指導原則，遵循 ICH-GCP的要求，秉承“方法科學、操作規范、管理完善、服務優質”的理念，不斷改善研究條件、提高研究水平、保證研究質量。近五年，醫院共承接藥物臨床試驗項目400余項，其中牽頭國內多中心研究 5項，參加國際多中心研究 60余項，完成創新藥早期臨床研究 20 余項，BE 研究 100 余項。
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.