缔脉生物医药科技（上海）有限公司

公司介绍
Company Introduction


缔脉生物医药科技（上海）有限公司是一家临床合同研究组织（CRO），旨在为中国及全球 生物医药公司和医疗器械公司提供高水准全方位的服务， 包括为客户就临床开发的各个方 面以及产品注册申报出谋划策，也提供与临床试验相关的各种支持。致力于提高研发产品的 成功率。
dMed Biopharmaceutical Company Limited is a clinical Contract Research Organization (CRO), providing high-end services to innovative biopharmaceutical and medical device companies. dMed is committed to increasing the probability of success of R&D products. Its services include scientific, strategic, regulatory and quality assurance related consultation for clinical development and product registration; clinical trial design and execution; clinical data management, statistical analysis, medical writing; pharmacovigilance and risk management; and clinical trial quality system and assurance.


我们的团队 Our Team

• 团队管理成员全部来自全球一流生物医药企业,或跨国临床研究外包服务企业的高级管理人员From executive and management team of global leading biopharmaceutical companies or multinational Contract Research Organizations
• 在各期临床试验及各类疾病领域拥有广泛经验，熟悉中国，美国，欧盟，日本等各地临床试验法规.
Expertise in various therapeutic areas and all phases of clinical trials, familiar with clinical trial regulations in China, US, EU, Japan and other markets
• 拥有高度责任感为客户服务，值得信赖的专业团队Trustworthy and Professional team with strong sense of accountability to serve our clients


服务对象及主营业务 Our Clients and Services

• 服务于中国生物医药和医疗器械公司，以及在中国开展临床研究的国外中小型生物医药 和医疗器械公司：临床试验设计及执行，试验数据分析及报告，注册文件及提交，系统 支持，功能性服务， 以及咨询服务（临床研发及注册策略咨询，技术咨询，国外开展临 床试验及注册的咨询）
Provide service for domestic biopharmaceutical and medical device companies and small and medium-sized biopharmaceutical and medical device companies interested in China market End-to-End Services including Clinical Trial design and conduct, clinical trial data Analysis and Report, Regulatory submission, Systems support, Functional Services, comprehensive Consultation Services (clinical development plan and regulatory strategies, scientific consultation, international facilitation for clinical trial execution and registration)

• 服务于跨国生物医药和医疗器械公司 (立足于中国，服务于全球临床试验)： 生物统计， 临床试验数据管理，临床编程，医学报告撰写，药物不良反应事件评估及风险管理，注 册文件支持及运作，质量监控及稽查
Provide service for multinational biopharmaceutical and medical device companies (In China for China & In China for Global), such as Statistics, Data Management, Programming, Medical Writing, Pharmacovigilance and Risk Management, Regulatory documentation support and operations, Quality Assurance & Audit


我们的服务 Our Services

临床科学及医学事务 生物统计与编程
Clinical Sciences & Medical Affairs Biostatistics & Programming

临床试验运营 数据管理
Clinical Operations Data Management

药物安全和警戒 医学撰写
Drug Safety & Pharmacovigilance Medical Writing

咨询服务 注册事务和战略
Consulting Regulatory Affairs & Strategy

培训 质量保证和稽查
Training Quality Assurance and Audit


关注点 Our Focuses

• 咨询Consultation
• 临床研发和注册策略咨询 Clinical development plan and regulatory strategy
• 试验方案设计 Protocol design
• 全球专业领域专家资源 Access to global experts (Scientific advisory board)
• 质量 Quality
• 帮助建立临床试验质量体系 ，符合稽查要求Help customers build quality framework, inspection readiness and oversight capability
• 创新Innovation
• 最前沿新技术的应用Take on latest technology & methodology in biopharma
• 以创新驱动临床试验效率Innovate to radically improve clinical trial efficiency
• 培训Training
• 资深人士提供培训, 成长空间Effective internal training mechanism to support growth
• 成为促进中国临床开发创新的主要驱动力A key contributor in the effort to improve clinical development capability and capacity in China


能力和经验
Our Capabilities and Experience

• 值得信赖和广为认可的专业素养Trustworthy and Professionalism being well recognized
• 各个治疗领域的专注与积累Expertise and capabilities in various therapeutic areas
• 植根于多文化的工作环境Deep rooted in multi-culture working environment
• 具有国际化视野并经过严格训练Global capabilities and rigorously trained
• 强大的资源网络和深入的协同合作Strong connections and collaboration
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