让我们共同优化您的罕见病药物研发

罕见病孤儿药研发

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Access expertise in global and local regulatory nuances to rare disease work including orphan or regenerative medicine advanced therapy designations and pediatric plans

Improve trial predictability through smarter feasibility to inform study design and data-driven strategies for delivery

Accelerate drug development and reduce risk for cell and gene therapies with specialized and coordinated capabilities

从事罕见疾病治疗的制药公司依靠创新的合作伙伴关系在这一充满挑战的领域中开展药物的战略性研发。 Count on our rare disease and pediatric team to provide critical expertise to advance your rare disease drug candidate to market.

Boost your rare disease patient enrollment

Patient access, recruitment and retention can be challenging in any trial but are uniquely difficult issues when working within rare diseases.不要让这一困难阻碍您的罕见病疗法研发。我们利用强大的分析解决方案(例如 Xcellerate® Clinical Trial Optimization® and access timely, real-world Labcorp diagnostic lab result data, global Central Labs investigator performance data and patient Intelligence input  that enable us to deliver faster patient enrollment and enhanced patient retention. In addition to this data, our strong relationships with leading advocacy groups, fit-for-purpose tools to support and educate study teams, sites, patients and their families, and dedicated, passionate and experienced recruitment and retention team make us the right partner to bring your product to market faster.

与我们合作,提高您研究的可见性和可信度,打造以患者为中心的解决方案,从而降低招募风险并保持研究的前进动力。

Leverage expertise and accelerate orphan drug development

业界对罕见病通常缺乏临床方面的了解,这凸显了创新性研究规划战略的必要性。我们的专家能够帮助指导您的罕见病临床试验,通过高效的研究设计,评估您期望的结果并结合经过验证的终点,获得更具相关性的结果。 Enable the development and collection of key clinical data in your studies with our innovative tools and approaches including biomarker discovery/development, mobile health, virtual natural histories and virtual trials.

有我们作为您的合作伙伴,您将获得专门的罕见病治疗领域专业知识与全面的运营支持,为您的全球性研究的各个方面提供协助。我们将共同制定完善的研究计划策略,以预见监管障碍,应对复杂的临床问题并加快您的前进步伐。

Maximize your commercial potential

即使孤儿药可以解决亟待满足的迫切医疗需求,了解市场影响对于最大化您在孤儿适应症方面的投资仍然至关重要。 By evaluating payers, providers and patients, we can generate real-world, value-based evidence that helps you determine pricing and set your market access strategies.

Work with a team that combines medical, scientific, operational and economic expertise with extensive clinical trial experience to enable your rare disease clinical program and enhance your potential for a higher valuation and return on investment. 

Supporting rare disease companies and overcoming orphan drug challenges

开发针对罕见病的孤儿药需要治疗领域的相关经验,并需要灵活操作以应对罕见病临床试验的独特挑战。我们提供各种各样针对罕见病药物研发量身定制的解决方案,涵盖从药物筛选到商业化的每一个阶段。

  • Access more than 5000 assays, including relevant biomarkers, through our central labs and Labcorp specialty testing groups
  • 利用徕博科的120位遗传咨询师以及基因组分层来甄选患者
  • 依赖我们成熟的物流解决方案,稳定地获得>99%的样本接收率,实现样本产量最大化
  • 凭借超过20年的罕见病和孤儿药开发市场准入咨询经验,帮助释放您产品的市场潜力

无论您正在进行小规模的I期研究,还是全球性的II-III期试验,您都可以依靠我们在罕见病研究方面的全球化实力和运营专业知识,充分满足您的项目需求并获得一致的结果。

An experienced approach to advance your rare disease program

除了帮助您确保罕见病志愿者,满足招募需求外,我们还提供孤儿药研发方面的丰富经验,并且拥有在数十个国家和数千个试验站点支持超过50种孤儿病适应症和103项罕见病研究的记录。以儿童为重点的罕见病研究具有更高的复杂性,而我们的团队已在全球各地超过25项此类研究中实施了成功的管理。

Let our multidisciplinary experts put their experience to work to advance your rare disease drug development program and transform obstacles into opportunities.通过合作,我们将提高您取得成功的潜力,并解决那些未得到满足的迫切的医疗需求。

按阶段和主要适应症划分的罕见病研究

Browse the Rare and Orphan Disease Education Center: 

  • 科技海报
  • 文章和白皮书
  • 博客文章
  • 视频和网络研讨会

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