临床服务

诺孚泰临床服务介绍

 

1.0国内临床服务简介

 

诺孚泰在国内正按照FDA、EMA及CFDA标准筹建临床研究中心及生物检测中心,将在19年上半年正式运营。我们聘请国际上在一期及BE研究领域超过15年经验的资深研究团队提供专业的管理及运营。从方案撰写、临床研究、生物检测、统计分析、报告及文献撰写等各方面,为客户提供一站式服务。公司主要针对中美、中欧双报项目开展研究。

 

试验类型:

BA/BE试验及I期试验

 

受试者人群:

健康人体(成年男性、女性及绝经后女性等)

 

Clinical Service in China

Our clinical site and bio-analytical lab have standard of FDA、EMA as well as CFDA. It will start operation in the first half of 2019.

We recruit oversea strong-experienced teams in Phase I study and BA/BE study field to operate and manage our CRO. We provide professional one - stop service for our clients from protocol writing, clinical phase, bio-analysis, statistic analysis, data management as well as report writing. The result can be submit to both CFDA/FDA and CFDA/EMA.

Study types:

l BA/BE studies and phase I clinical trail.

    Subject Pool :

l Healthy adults (Male and Female, Postmenopausal female, etc.)

 

 

2.0国际临床简介

 

国际合作中,为满足不同客户的需求,我们与美国、欧洲、加拿大、澳洲及印度符合标准且多次通过USFDA、EMA等机构组织审计的CRO公司达成战略合作,为客户提供全方位的临床试验服务。

 

试验类型:

临床前动物实验

BA/BE试验、临床I, II, III, IV期试验

全球多中心项目

 

受试者人群:

健康人体(成年男性、女性及绝经后女性等)

肿瘤患者及精神病患者

 

 

Clinical Service Oversea

Regarding our international service, in order to meet with the requirement of different clients, Greensyn cooperates with CROs from India, USA, Europe, Canada and Australia. Base on your requirement, we will help you find proper resources for different study types.

 

Study type:

Pre-clinical animal atudy

BA/BE studies and phase I, II, III, IV clinical trails

Global clinical trails

 

Subjects Pool:

Healthy subjects( Male, Female, Postmenopausal female, etc)

Patient( Oncology, Psychosis)