PPC 佳生(PPC Group)

成立于 1997 年,致力于为国内外制药企业及生物技术公司提供专业化临床研究服务,为中国大陆、台湾、韩国以及日本等亚太地区客户提供临床试验及生物样本检测分析服务。自 1997 年至今,PPC佳生已经完成了超过 2000 项早期临床试验项目,其中包括创新药 I 期研究、仿制药生物等效性研究以及生物类似药早期临床研究(包含新药 I 期 PK、仿制药 BA/BE 以及生物类似药 PK/PD)。同时,PPC 佳生也已经完成超过 470 项II 期至 IV 期临床试验项目,其中涉及 24个主要研究领域。目前 PPC 佳生是亚太区域唯一通过台湾 TFDA,日本 PMDA,法国 ANSM,东盟 NPRA,美国 FDA 以及中国 NMPA(CFDA)核查的临床基地

2012 年,PPC 佳生于台北(MacKay Memorial Hospital)建立了第一家下属 I 期临床研究中心;2017 年初作为主要投资方与徐州医科大学合作共同建立了徐州医科大学附属医院 I 期临床研究中心;2018 年,PPC 佳生又分别与徐州市中心医院,黄石市中心医院以及上海市浦东新区人民医院共同建立并开设了三家专属的 I 期临床研究中心

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PPC GROUP INTRODUCTION

PPC group was founded in 1997, provides professional services for clinical studies to pharmaceutical and biotechnology companies. PPC group offers clinical and laboratory services in China, Taiwan, Korea and Japan. Since 1997, PPC has completed over 2000 early phase trials, including innovative phase I pharmacokinetic, generic bioequivalence and biosimilar studies, to pharmaceuticals companies. In addition, PPC group has conducted over 470 innovative phase II-IV trials, covering all 24 therapeutic arenas. We have been audited more than 30 times by numerous regulatory authorities, including FDA, PMDA, NMPA(CFDA), ANSM, NPRA and etc.

To fulfill harmonized bioequivalence standard for phase I clinical site, PPC group has set up a phase I center in Taipei MacKay Memorial Hospital in 2012; and co-found a phase I center with Xuzhou medical hospital in early 2017. Combining the strengths of Xuzhou Medical University, PPC has established strong early phase drug development especially in the bioavailability and bioequivalence research field over the past two decades. In 2018, PPC had set up 3 more dedicated Phase I Units in Xuzhou Central Hospital, Huangshi Central Hospital and Shanghai Pudong People’s Hospital