Championing your success in cardiovascular diseases
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揭示治疗心血管疾病的新可能性
我们可以一起浏览演变的医疗和监管市场
确定机会。转变结果。
Enable success through our expertise and precision delivery
您的试验是否涉及传统的小分子对充血性心力衰竭的高血压或尖端干细胞疗法的方法，我们为您提供了富有洞察力的试验设计，预测性研究管理和先进的心脏成像，为您的程序增加了价值。专家心血管医疗团队与运营服务卓越相结合有助于确保用于您的分子或设备的新解决方案。
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专用心血管专家
专用心血管专家
独特的成像体验使您成为成功
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Perform the right tests in proof-of-concept and Phase II trials by taking advantage of our cardiologists’ extensive experience in advanced cardiac imaging
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通过利用目前服务的医生团队或服务的基于尖端成像的研究，为您的尖端成像的研究专长增加价值，作为学术领导人和核心影像和心电图实验室董事
Our dedicated cardiovascular specialists have a unique combination of academic and industry experience essential to successful study planning and execution.
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复杂的全球巨型试验
复杂的全球巨型试验
高效的试验性能。迎接挑战。
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Optimize site selection for a better return on your investment using our proprietary knowledgebaseXcellerate®, which includes site performance information from the world’s largest central laboratory and clinical database
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Take advantage of our strategic relationships with学术研究组织, which allow us to leverage their insights into site quality and tap into their investigator networks to motivate recruitment
Navigating cardiovascular mega-trials is a challenge. Success often depends on investigator interest and recruitment of appropriate patient populations.
复杂的全球巨型试验
Manage risk. Create data-driven insights. Maximize potential.
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Take the risk out of your trial with our tailoredrisk-based monitoring提供最大严格的方法，同时最小化研究成本
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Assess and adjust predictions to incoming data in near real-time using ourdynamic modelingmethodology
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通过利用我们的学术声望和智力信誉，说服监管机构和医学界的福利或设备的利益学术研究组织伙伴
Your goal is flawless data. Our goal is to provide you with the resources to deliver trial outcomes with unquestioned credibility.
复杂的全球巨型试验
Reduce timelines. Increase operational efficiencies.
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将我们的广泛网站启动和绩效指标的数据库纳入我们复杂的informatics algorithms, which are validated by more than a decade of clinical trials
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利用最经验丰富的一个adjudications行业中的群体，轨道记录成功管理200多个全球临床终点试验
Time to market is critical for any drug development program. Let us help you cross the finish line sooner.
复杂的全球巨型试验
Case Study #1
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An increased number of sites and enrolled patients resulted inon-time accrued endpoints
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改进的报告工具导致随机数据库锁三项研究和超过10,000名患者
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Flawless, cleaned and consistent data enabled the client to申请FDA和EMA批准
A pharmaceutical company needed to conduct a series of Phase III studies for a new cardiovascular medication
复杂的全球巨型试验
案例研究＃2
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复杂的试验，超过10,000名患者，started three months ahead of schedule
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Last patient entered treatment 12 months ahead of the original timeline, saving the client significant time and money
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我们无情的后续行动和对患者安全的承诺导致了一个0% loss of patients
需要一个大型制药公司，帮助开发一种药物，可以最大限度地减少与高风险血管疾病相关的风险
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Global Regulatory Expertise
Global Regulatory Expertise
Local expertise. Global strength.
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Navigate regulatory requirements by designing a globally relevant protocol that can support regional policies and guidelines
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Embark on an efficient development program by performing a target product profile and gap analysis early on
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通过将监管智能转化为关于端点的洞察力来预测明天的需求
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用产品登记和试验结束活动设计您的临床研究
强劲的监管策略在让产品到市场上的关键。随着全球监管要求继续发展，通过利用超过150多个国家的监管事务专业人士增加了批准的机会。
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End-to-end solutions aligned with your needs
We are personally invested in your drug’s success from beginning to end. Our holistic suite of services, starting at lead optimization and incorporating Market Access Consulting solutions throughout your development program, can help maximize your drug’s ROI.
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Preclinical Services
Preclinical Services
风险最小化。格言ize your chance of success.
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使用成熟的心血管技术（如成像和皮肤血流量）分析候选者期间候选者的疗效
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Help predict clinical outcomes with biomarkers in exploratory and surrogate-based studies
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得到的答案早在安全使用各种nonclinical cardiovascular safety assessment techniques and gain critical information for your go/no-go decision
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利用血脂血症和心力衰竭动物模型等地区临床前研究的翻译价值yaboapp体育官网
Preclinical Services
Case Study #1
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设计了一个阶段，解决了毒理学研究中发现的特定临床问题和挑战，包括剂量和剂量升级，包括普及/排除标准和ECG监测增加
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该学习前进了1.5个月than had the client taken a traditional phased approach
A small pharmaceutical company needed to conduct a thorough safety assessment to use in guiding their clinical program
Preclinical Services
案例研究＃2
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对临床前和CMC研究的无瑕疵执行 - 并第一yaboapp体育官网次获取FDA批准的文件 -保存了客户的重要时间和金钱
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审查临床前研究导致优yaboapp体育官网化FIH研究，creating future efficiencies
中型公司需要有助于确定其发展战略，从临床前向临床发展推进其药物yaboapp体育官网
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临床服务
临床服务
毒品衰竭的主要原因是无法记载心血管结果的改进
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Incorporate biomarkers most predictive of risk or success into your clinical trial by tapping into our翻译生物标志物解决方案
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通过利用我们的性能数据来优化站点选择和患者招聘中央实验室服务是世界上最大的中央实验室，在超过175,000名患者中进行了近300个持续的300个心血管研究
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使您的产品更快地推向市场 - 并更聪明 - 我们的目标战略Market Access Consulting团队，其解决方案在潜在和成功之间存在差异
临床服务
Case Study #1
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二手Xcellerate®预测每月招聘并确定新患者的数量和位置，导致FPI对目标和最终协议的11周内
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Recruitment completed nine months ahead of expectation
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Provided forecasts on CRF flow to assign proper data management resources and prevent delays in data processing, leading toregulatory filing more than one year ahead of original timelines
一家大型制药公司需要进行III期安慰剂对照试验
临床服务
案例研究＃2
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Used Xcellerate® to decrease the number of sites and countries,大大减少预算
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Achieved a screen failure rate of less than 15%
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精确定位最佳网站外展和选择以帮助提前12个月完整注册
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Realized 0% loss to follow-up
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Attained on-target endpoint accrual
A large pharmaceutical company needed to conduct a Phase III trial with 12,000 high-risk cardiovascular patients
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让我们从过去的经验和跨功能解决方案中带来洞察力给您的心血管计划
Partner with a company that has conducted more than 350 cardiovascular studies in 75 countries with over 200,000 patients over the past five years
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Heart Failure
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Atherosclerosis
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Arrhythmias
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Thrombosis
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Hypertension
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Devices
让我们开始对话。
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