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眼科学

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Advance your ocular therapies with the only full-service contract research organization to offer personalized ophthalmic drug development services that span the entire continuum from discovery and preclinical to clinical trials and post-market follow-up studies. 

Whether you need support with anterior or posterior segments, rare ocular diseases, gene therapies or ophthalmic devices and diagnostics, we know how to optimize your ophthalmic development.

为您的眼科计划制定战略愿景

  • Rely on our ophthalmic staff’s deep scientific and regulatory experience from delivering more than 120 global, patient-centric ophthalmology clinical trials for emerging biotech companies over the last five years

  • Work with renowned vision scientists as part of our more than 30-year relationship with Ocular Services on Demand (OSOD) to handle your preclinical ocular needs and deliver specialized expertise in the ocular surface and anterior and posterior segments

  • Enable intelligent patient recruitment with advanced data and increase your efficiencies with our established relationships with more than 2,000 global sites

Extend your ophthalmic team’s expertise with a full-service collaboration

在决策时将患者的需求放在首位并确保您的眼科药物研发计划成功的方面,经验至关重要。在过去五年中,徕博科运用专业知识和见解帮助推进了120多项临床眼科研究,为新兴和中型生物技术公司提供灵活的解决方案。

获取所需的跨职能支持和定制策略,以加快研发进度、预测和预防问题并将眼科疗法推向市场。 Together, our robust partnership can help your team improve patient lives faster.

获取量身定制的临床前解决方案

You may need toxicology (good laboratory practices and non-good laboratory practices), tissue distribution/pharmacokinetics and pharmacology to support your ophthalmology preclinical research. 我们了解眼表、前段和后段之间的独特差异,并可以提供多个眼病领域的专业知识,例如青光眼、干眼、葡萄膜炎、过敏和视网膜疾病。

我们在所有药物/疗法类别的经验以及我们与OSOD的合作伙伴关系也可以让您的临床前试验受益,从而为多种模型提供眼部给药途径。

与徕博科一起进行眼科研究时,您的团队还可以使用我们的全方位服务实验室,以满足化学生物分析服务方面的任何需求。探索我们一体式综合实力的与众不同之处。

独特的临床试验和测试解决方案

我们的交付成果以独特的临床试验和测试解决方案为中心,这些解决方案既以患者为本,又可以灵活地满足您方案的需求。

  • Accelerate patient recruitment and site identification – Access our de-identified lab results and patient intelligence data to help identify patient clusters to evaluate inclusion/exclusion criteria, pressure-test protocols and help locate patients near proven, experienced investigator sites that are part of our tracked and trusted network
  • 获得科学和法规支持 - 通过我们的法规和商业准则扩展您团队的能力。 Count on our extensive experience in assisting both small biotech and large pharmaceutical companies to help you achieve your strategic goals
  • Apply flexible, integrated delivery models – Whether you need to apply decentralized clinical trial approaches to mitigate delivery risks or take advantage of our full service or functional service provider models, we can work together to optimize your delivery

我们根据您的喜好和项目需求设计交付能力。采用这些全方位服务解决方案,同时我们会使用Xcellerate® 信息学套件跟踪您项目的里程碑和数据。


Delivering expertise with OSOD

由超过40名国际知名的眼科科学家组成的联盟推进您的眼科方案。 Since 1999, we have worked with OSOD to help both emerging biotechs and large pharmaceutical companies work with vision science experts, such as board-certified veterinary ophthalmologists, electrophysiologists (for electroretinograms), veterinary and physician pathologists, clinicians and professional ocular photographers, as well as basic scientists in a wide range of ocular science areas.

Your team will receive unsurpassed vision science consulting—spanning study design, data acquisition/interpretation, clinical translation and regulatory strategies—and benefit from state-of-the-art instrumentation for comprehensive descriptive and functional evaluation of your endpoints. 

Optimizing your trials and focusing on the path to commercialization

针对眼表和前段研究的解决方案

在涉及眼表和前段的试验中获得专家支持。从白内障、青光眼和干眼症到过敏和炎症,以及隐形眼镜和人工晶状体,以及外科手术和给药设备,我们可以将通过支持众多研究得出的经验教训应用于多种关键适应症。

针对后段研究的解决方案

我们的视网膜专家在黄斑变性、糖尿病性视网膜病变、色素性视网膜炎、玻璃体粘连、增生性玻璃体视网膜病变和炎症等全球研究领域拥有丰富的经验,将为您的团队提供有力支持。我们还具有眼科罕见病以及眼科细胞和基因疗法方面的独特专业知识。

案例研究

A superb teamwork (collaboration) that saved time for sponsor’s NDA for a first in class drug.

 
按阶段划分的研究的饼形图和按适应症划分的研究的条形图

通过强大的患者招募、参与和保留策略来推进复杂的临床试验

With a strategy tailored to your ocular disease indication, our holistic approach starts with established site relationships to find the strongest high-performing sites for your study and leverage existing agreements to expedite start up. We can also analyze our proprietary Labcorp deidentified data and filter by ICD10 diagnostic codes to geolocate patient populations closest to your sites. 通过与我们专业的主题专家团队开展合作,您将获得一个全面、以数据为导向的研究中心和患者参与策略,该策略融合了我们从以往及目前的眼科试验中总结的最佳实践。

一旦您的试验开始实施,您就可以依靠我们的眼科临床试验管理团队进行密切的沟通和协作。 We work to identify certified vendors that perform visual acuity assessments and central reads of the ocular imaging and use our highly flexible, in-house clinical platform for electronic patient-reported outcome so you can receive high-quality data and stay connected to the progress of your program.

Intelligent recruitment, inspiring science and integrated delivery

Advance your study with a contract research organization that provides clinical, scientific, regulatory and operational perspectives coupled with ophthalmic experienced teams that keep the patient at the forefront of your design decisions. 从研究中心选择到患者招募策略以及生成高品质数据,我们随时为您效劳,帮助减轻患者和研究中心的负担,降低风险并优化整个方案的流程。

探索与提供端到端药物研发服务的专业合作伙伴开展合作的与众不同之处。我们可以共同为您的眼科产品找到最佳的前进方向。

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