A comprehensive approach to cell and gene therapy clinical development

细胞和基因疗法在传统疗法不足的情况下提供了巨大的希望。这些创新的疗法需要绘制新的风险区域。我们的多学科细胞和基因疗法团队有望帮助您更早地为患者带来改变生活的治疗。

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A broad range of experience and a proven track record of success

我们在细胞和基因疗法(CAGT)的整个景观方面具有独特的视角。我们与Biotech和大型药房客户进行了广泛的合作,并借鉴了我们的Brad经验,以制定量身定制的解决方案,以帮助赞助商优化和加速其临床开发。

This is who we are, what we do, and how we're different.

CELL AND GENE THERAPY MEDICAL EXPERTISE

Our expert CAGT Medical and Scientific Team advise sponsors on all aspects of CAGT clinical development

Our CAGT Center of Excellence includes highly experienced physicians and clinical operational experts with direct medical, scientific and clinical development experience in CAGT. We harness IQVIA data and innovations and advise on protocol design, regulatory, clinical operations, real-world evidence needs, specialized lab requirements, and commercialization strategies.

We craft tailored strategies for all aspects of CAGT clinical development, especially clinical trials. We work in partnership with our CAGT clinical operations teams and other IQVIA indication-specific Centers of Excellence.

CAGT CLINICAL DELIVERY EXPERTISE

Our specialized CAGT Clinical Operations and Logistics Management teams expertly deliver CAGT trials.

CAGT trials demand meticulous delivery and management of logistics. We have first in class solutions to optimize CAGT study execution.

对于我们的生物技术客户,我们开发了一个创新的多学科CAGT单元,其中CAGT卓越中心与经验丰富的CAGT临床运营团队合作,以确保无缝的临床计划策略和交付。

Our Logistics Management Program features experienced logistics managers, supply chain teams, and partnerships with shipping vendors. We are also experienced in the latest tracking tools and innovations in Chain of Custody/Identity verification.

CAGT全球站点网络

我们利用数据驱动的见解和建立关系来确定最佳网站。betway必威怎么提款

我们的全球CAGT网站网络包括全球160多个网站,包括亚太地区和拉丁美洲的经验丰富的网站。我们的CAGT网站有专家研究团队,细胞和基因疗法的基础设施以及必要的CAGT认证。

CAGT患者招募和参与

We use patient-centered and data-driven approaches to identify and recruit patients

CAGT试验通常涉及罕见,小儿和患有晚期疾病的患者。我们使用以患者为中心的策略来确保患者负担最小,并专有IQVIA数据来优化和加速这些具有挑战性的人群的招募。

我们的患者参与工具箱包括量身定制的CAGT招聘材料,礼宾服务和电子同意。我们还利用广泛的数据和生物标志物网络来查找和识别合格的患者。最后,我们使用创新方法来最大程度地减少患者负担,包括分散试验和远程数据收集。

CAGT现实世界证据解决方案

我们使用创新的研究设计并利用现实世界数据来简化CAGT长期随访

Real world evidence is critical to many aspects of CAGT clinical development. We work in partnership with our Real-World Solutions teams to craft innovative study designs and strategies for long term follow up, natural history studies, and external comparator studies. We also leverage our real-world solutions to inform payor and commercialization strategies.

CAGT监管解决方案

We provide regulatory strategy, advice, and consulting from pre-registration to post-registration. Our program includes a wide range of services including regulatory intelligence, regulatory maintenance and lifecycle support, marketing applications, accelerated approval designations, INTERACT/Pre-IND/IND consultation, prioritization and target product profiles.

CAGT PRE-CLINICAL SOLUTIONS

我们提供CMC策略,标签和GMP合规性审计支持。我们还提供预科和科学咨询会议咨询。通过加州再生医学研究所(CIRM)的奖项,我们向CIRM授予者提供临床前服务。

CAGT Lab Solutions

IQVIA’s Q2 Lab Solutions offers an extensive array of CAGT lab solutions to meet the unique demands of CAGT clinical development.

我们的CAGT卓越中心与第二季度解决方案科学家和运营团队合作制定了定制实验室策略,这些策略符合特定的临床需求。

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伊克维亚的经验

> 18,000名患者

自2012年以来参与细胞和基因治疗试验的70个国家 /地区
内部分析,2012 - 2020年,IQVIA CAGT COE 2022年6月

使用IQVIA连接的情报驱动更聪明的决定

我们强大的方法汇集了CAGT专家,数据驱动的见解,全球站点网络和创新技术,以帮助您推动更明智的决策以加速CAGT临床开发。必威官方在线betway必威怎么提款

相关解决方案
真实世界Solutions

产生并传播正确的现实世界证据(RWE),以充满信心地满足利益相关者的需求。

分散试验

IQVIA分散的试验提供专门建立的临床服务和技术,无论他们身在何处。必威官方在线

患者招募

Predict enrollment more accurately and increase the number of patients per site using data-driven patient recruitment solutions.

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