独立中心影像评估

肿瘤

肿瘤领域专业知识

凯理斯科学咨询人员具有行业内最丰富的肿瘤临床试验影像经验。我们已经成功地管理超过1500项临床试验的成像部分,涉及90种肿瘤适应症。This includes more than 50 pivotal studies – where imaging data supported successful submissions to regulatory agencies – and over 75 trials of compounds that were designated breakthrough therapies.

 

Solid Tumor

During the course of anti-tumor treatment development, imaging modalities, criteria, and regulators’ expectations change frequently. 没有在临床试验成像中日复一日工作的成像科学家的指导,在这些关键和经常冗长的试验中,很难跟踪和应对变化。

Calyx’s scientific and medical experts have successfully managed the important imaging components of over 1,300 solid tumor trials – in all phases of clinical development across multiple indications such as cancer of the prostate, breast, bladder, and many more. You can trust Calyx to guide you through the highly nuanced and technically challenging world of clinical trial imaging to ensure your solid tumor development program succeeds. 就算项目失败,也绝不拖延。

Calyx Medical Imaging: Oncology Trial Experience >

血液学

凯理斯的专业科学和医学团队在成功实施和执行血液学试验方面拥有丰富经验,能提供复杂临床数据管理的解决方案和先进影像。Our experience includes 300+ hematology trials, including support of 40+ approvals in Lymphoma, CLL, Waldenstorms and Multiple Myeloma.

凯理斯与 Bruce Cheson 医生、Joseph Mikhael 医生和 Shaji Kumar 医生等关键意见领袖密切协作,帮助我们解决标准之间的差距,我们还与许多来自知名院校、在 Lugano、iwCLL、IMWG、LYRIC、RECIL 等各种血液学标准方面有丰富经验的专业认证审核人密切合作。

You can trust the Calyx Medical Imaging team to provide reliable consultation on hematology trial design, template charters, and applications based on our lessons learned from previous studies incorporating reviewer, KOL, and regulatory feedback.

神经肿瘤学

凯理斯为神经肿瘤临床试验提供各种久经考验的影像服务。我们的科学顾问和内部专业知识网络能提供全面的服务,帮助您从产品发现迈入产品上市阶段。

凯理斯在神经肿瘤影像方面的经验包括:

- 利用适当的标准和分析方法,在对比度增强的CT 和 MRI 上对原发性或转移性肿瘤检测/扩散成像
- 将序列叠加以分割出肿瘤和水肿体积,并随时间推移进行跟踪
- 根据研究需要进行高级 MRI 分析

驱动科学创新

凯理斯聘请了多位行业内重要意见领袖,其中就包括曾撰写过关于肿瘤临床试验中医学影像书籍的 Oliver Bohnsack 博士。作为免疫相关反应标准 (irRC, 2009) 的共同作者,Bohnsack 博士是还是 irRECIST (2014) 的第一作者,并还与 ManitzJ. 等人合著了使用 “Comparison of Assessments using RECIST andirRECIST”(《使用RECIST和irRECIST的评估比较》)(2020)。在为凯理斯开发肿瘤新疗法的客户设计和实施最佳影像策略时,Bohnsack 博士便充分利用了自己此前的丰富行业经验。Dr. Bohnsack leverages his knowledge from having co-authored the immune-related response criteria (irRC, 2009), served as first author of irRECIST (2014), and co-authored Comparison of Assessments using RECIST and irRECIST by Manitz J. et al. (2020) as he designs and implements optimal imaging strategies for Calyx’s customers developing new oncology treatments.

了解我们的专家

全球支持

凯理斯的医学影像团队利用我们运营模式高度成熟的业务布局,从各个研究中心收集复杂且经过优化的中枢神经系统图像,稳健地在全球各地推进影像策略的落地实施。

凭借在印度、中国、北美和欧洲的本地化支持,您将能够对所发起中枢神经系统试验影像部分的平稳运行,以及获得值得信赖的高质量数据做到成竹在胸。凯理斯将始终致力于提供让您满意的服务。凯理斯将始终致力于提供让您满意的服务。

了解我们在治疗领域的专业知识

凯理斯的专业知识涵盖临床开发的各个阶段和不同的治疗领域。In addition to Oncology, we have significant experience and proven capabilities in providing medical imaging services to support the clinical development of new treatments in oncology, musculoskeletal, and many other therapeutic areas.

文库

在肿瘤学临床试验影像分析中,如何更好地评估阅片人的疲劳度

Fatigue is an insidious, pervasive and often overlooked issue in oncology trial imaging. Identifying reader fatigue and understanding its impact on image interpretation can help shape the design, selection and management of clinical trials.
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改进肿瘤学研究中评价治疗疗效的方式

Join the discussion on irRecist with Calyx’s Head of Oncology, Dr. Oliver Bohnsack and discover what's next in oncology research.
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先期的阅片人监测可提高临床试验影像评估的质量

加入我们,了解如何以易于理解的方式简化 Calyx 应用的高度复杂的统计驱动指标,以支持强大的数据驱动质量监控流程。
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凯理斯为突破性肿瘤疗法获批提供支持

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