Helping you design success!
Helping you design success!
Polaris Strategic Partners is a preeminent provider of clinical trial services for emerging and growing biopharmaceutical companies with global aspirations to conduct clinical development projects in US and China.
We provide a complete range of clinical trial operations capabilities that are all customizable to meet your needs. Our integrated study management project and trial execution services are specifically designed to achieve the most cost effective and high-performing trial operations in US. Our partnership with you enables your connection to confidence and clinical trial success.
Clinical trials are sophisticated research projects performed in a complex business environment. Emerging and growing companies have a limited number of assets at the clinical stage. As a result, you rely on your clinical trials to be meticulously conducted in order to achieve business goals by bringing new and differentiated products to the market. There is no room for error. This unique need can hardly be met by large clinical contract research organizations (CROs) whose operations and business models are geared toward supporting mature companies with large clinical portfolios.
The CRO industry is evolving from large, one-size-fits-all offerings to bespoke, culturally matched services that are more effective. We are leading this change with our unique PolarisConnect platform. Through PolarisConnect, we focus on sourcing best-in-class clinical trial capabilities and designing unparalleled trial execution plan that is unique to support ex-US emerging biopharmaceutical companies to achieve trial success in the US. We provide tailored strategic guidance as well as seamless service execution that is anchored by decades of world-class experience in commercial clinical trial operations and outsourcing. Our expert advisors are all from rich background of drug development sponsor companies ranging from small biotech to large global organizations. We bring deep therapeutic area expertise with proven track record of managing clinical trial businesses in prestigious pharmaceutical and rare disease companies.
Polaris Strategic Partners is your partner for better trials. We focus on your needs and operate in a culturally sensitive way. We provide insightful guidance, practical know-how, valuable connections and comprehensive solutions to support you to achieve trial success in the US.
由临床运营各领域的世界顶尖专业人士组成, 包括在美国本土的新药临床运营领导者, 以及跨境工作经历的资深人士。他们曾主导全球一流制药公司Merck, GSK, MedImmune, AstraZeneca, REGENXBIO等企业的临床运营, 均具有二十年以上美国本土及国际地区几百项新药临床运营的工作经历, 兼顾大型制药企业和中小型生物科技企业, 拥有坚实的专业学科基础, 包括肿瘤、基因治疗、罕见病、心血管疾病、自身免疫疾病及感染疾病等新药研发的领域。
是通过开创独特的 PolarisConnect 药物临床试验(Clinical Trial Operations) 运营管理服务平台, 打造第一流的临床项目执行模式。本平台基于美国本土, 以中美国际合作为中心, 让合作伙伴能够最佳地融入美国本土的先进医疗环境和卓越临床资源, 精心设计最为合理有效的临床运营解决方案和管理服务。
服务对象的重点和中心, 是来自中国的中小型制药企业, 特别是具有创新精神的中小型企业。他们计划将自己新药研发项目的临床试验在得到FDA的正式批准 后, 放到美国来进行。众所周知, 新药临床试验的运营, 要比临床前期的研发过程更加复杂; 而新药一旦进入临床试验, 其管理规范(GCP)的要求, 也会比此前更加严格。因此, 新药临床试验的运营和管理是否成功, 将会直接决定医药企业在新药研发上最终能否取得成功。
现今的美国, 是新药临床实验的最佳选择地, 拥有四千多家新药研发合同外包公司（CRO), 上万家临床试验点(clinical sites)。这是一个充满活力的理想运营环境, 但也异常庞大和极为复杂。面对如此陌生的运营环境, 来自中国的中小型医药企业, 怎样才能在最短的时间之内, 从众多的临床试验服务公司中挑选出最适合自己的服务商？又该如何与选定的服务商进行高效率的谈判, 从而成功签订各种相关的合同文书？又该如何在合同的执行过程中, 严格保障项目的进度和质量, 使之完全能够符合GCP的各项规范？如果中途出现问题, 又该如何与对方进行及时而有效的沟通, 圆满解决已经出现的问题？显然, 如果没有十年以上直接在美国本土管理临床项目的运营经验, 就很难妥善处理以上的种种难题。
但是, 大型的美国CRO并不适合中小型的中国医药企业, 因为大型美国CRO的主要服务对象是大型国际制药企业, 他们即便为国际中小型客户服务, 也很难慷慨提供最优秀的团队、最经济的方案和最严格的管理, 更不会为国际医药企业配备跨境工作经历的资深团队。 这样一来最有可能出现的结果, 就是国际小型客户花了一流的资金, 接受的却是三流的服务, 很难保证自己新药临床研发的成功推进。
对于中国的中小型制药企业而言, 华美北辰才是您最好的选择。因为我们服务的重点和中心, 正是来自中国的中小型制药企业, 特别是具有创新精神的中小型企业。 我们以创新药企的视角精选临床运营服务资源，以药物研发为本， 通过独特的PolarisConnect运营管理服务平台, 为客户量身定制最理想的新药临床运营解决方案, 并且安排资深的一流团队进行全方位的项目管理服务。我们独一无二的创新服务模式, 是现有任何CROs不能提供的。
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