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  • 加盟时间:2015年04月14日
机构简介

BC-BIOSTAT is a CRO (Contract Research Organization) with Belgium and China joint venture.
We provide a range of professional full services, from protocol design until the China Food and Drug Administration (CFDA) submission, for medicines, medical devices, biological products, health care products, diagnostic reagents, and cosmetics.
We provide full services including Product Registration, Protocol Design,Randomization (IVRS/IWRS), Clinical Monitoring and Audit services for
clinical trials from Phase I to Phase IV, Data Management (EDC system), Statistical Analysis & Report (SAR), Clinical Study Report (CSR), Translation, article publication on SCI journals, presentation to the CFDA experts, and so on.

Our team brings together the world-class biostatistics and data management experts (Prof. Geert Molenberghs & Prof. Emmanuel Lesaffre).

The company commits to provide services in professional bio-pharmaceutical research, and to develop Chinese medical academia and industry to meet international standards of clinical trials, especially data management and biostatistics services.
Since we started our business in China, we have established a very good cooperative relationship with pharmaceutical companies, clinical trial bases which are approved as clinical trials qualified hospitals by CFDA and the regulatory authorities of the Pharmaceutical Affairs. We have all kinds of professional and technical employees. We employ the national drug review experts, the institution directors and the clinical expert council which has extensive influence in new drug clinical research.
We can act as an agent for international pharmaceuticals to bring their products into China, and help Chinese pharmaceuticals enter into European markets.
BC-BIOSTAT manages the introduction of foreign products into the Chinese market, and conduct product registration and registration clinical trials.

北京比中生物医学科技有限公司是由比利时生物医药统计有限公司和比利时生物信息技术有限公司及海归学者共同在北京创立的临床研究CRO(Contract Research Organization)公司。

欧盟首都比利时在生物医药研究与开发领域雄居世界领先地位,站在巨人的肩膀上的比中生物是一家国际化领先的临床CRO机构。我们致力于向医药企业和研发机构临床试验提供临床试验一站式服务,由此汇集了世界一流的临床研究专家(Prof. Geert Molenberghs, Prof. Emmanuel Lesaffre)。公司成立以来不断吸收国内临床注册、稽查监查的人才,与药厂、临床试验基地(CFDA认可的具有临床试验资质的医院)和食药监建立了良好的合作关系。我们的临床专家团队由国家新药审评专家、基地主任和在新药临床研究方面具有广泛影响力的专家教授组成;我们致力于为我国学术界和产业界的生物医药研究与开发提供专业的符合国际标准的临床试验全程服务, 特别是在国内CRO公司技术较薄弱的数据管理和生物统计服务方面;我们的努力,将为推动我国创新药物临床试验国际化进程贡献一份力量。

比中生物医学科技有限公司提供国内外医疗器械、生物制品、新药、化妆品与保健品等产品注册服务,I期至IV期临床试验相关的一系列专业技术服务,从临床试验开始的试验方案设计到向药监局提交临床总结报告并答辩的整个过程。 包括产品注册、研究方案设计、随机化、项目管理、临床监查稽查、 数据管理、统计分析、临床研究报告撰写、协助研究者发表SCI文章、市场调研和产品开发战略咨询、临床试验各阶段技术人员外派等。

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