PrecisionDx (CDx)
伴随诊断和精准医疗的综合专业知识
我们专注于同步制药和IVD工作流，确保诊断无缝集成到临床开发中。我们的专业知识覆盖伴随诊断(CDx)的完整生命周期，提供满足药物和器械法规要求的统一策略。
Powering precision medicine — enabling CDx success
QbD Group partners with both pharma sponsors and IVD teams to accelerate precision medicine programs and companion diagnostic (CDx) development. Our integrated team aligns biomarker strategy, assay development, clinical execution, and global regulatory pathways to deliver faster, safer, and compliant drug–diagnostic co-development.
From early biomarker validation and clinical development strategy to FDA Q-Sub/PMA, IVDR Annex XIV, ISO 20916 clinical studies, and quality system readiness, QbD Group serves as a single, unified partner across the entire precision medicine and CDx lifecycle.
We bridge translation science, regulation, and clinical operations to bring your therapy and diagnostic to patients sooner.
我们解决的关键挑战
跨职能复杂性
CDx项目需要在制药和IVD法规路径、临床开发策略和质量体系之间对齐。
双重法规框架
在IVDR和CTR下同时导航制药和IVD法规会产生错位和延误的风险。
性能研究执行
设计和执行符合附件XIV要求的临床性能研究，同时与制药发起人、CRO和检测中心协调。
发起人委托的复杂性
制药和诊断企业越来越多地委托发起人责任，需要值得信赖的合作伙伴。
IVDs in Clinical Trials: The Sponsor's Survival Guide
In this episode, Kirsten and Annelies discuss the challenges pharma sponsors face when integrating IVDs into clinical trials — and how to navigate IVDR and CTR requirements with confidence.
Featuring: Kirsten & Annelies
我们的结构化方法
法规策略和项目管理
定义您的CDx法规策略，对齐药物-诊断协同开发时间线，并协调跨职能项目管理。
发起人委托服务
作为IVD/CDx性能研究的发起人代理，确保完全符合IVDR和CTR。
法律代表(IVDR第58(4)条)
在欧盟代表您的组织进行性能研究，确保符合IVDR的监督。
性能研究设计和执行
设计和实施符合附件XIV要求的临床性能研究。
检测中心监查
通过基于风险的监查识别、评估和确认检测中心。
递交和授权
准备递交文件包，管理与主管当局和伦理委员会的互动。
300+ studies completed across Europe
From feasibility to post-market, our dedicated IVD CRO team brings deep regulatory knowledge and clinical expertise to every study — ensuring first-time-right submissions and faster market access.
你将获得
Unified drug–diagnostic strategy
One partner managing both pharma and IVD regulatory pathways for seamless co-development across the entire CDx lifecycle.
Faster time to market
Aligned timelines, coordinated submissions, and integrated clinical evidence reduce delays in precision medicine programs.
Reduced compliance risk
Cross-functional expertise minimizes gaps between drug and diagnostic development, IVDR and CTR requirements.
Sponsor delegation confidence
Full compliance, visibility, and strategic alignment under IVDR and CTR while you retain overall sponsor oversight.
Global regulatory coverage
From FDA Q-Sub/PMA to IVDR Annex XIV and ISO 20916, we cover global regulatory pathways for CDx programs.
QbD IVD | Qarad helped us navigate the IVDR transition with confidence and precision. Their expert guidance and true collaboration reinforced our credibility with pharmaceutical partners.
Russell Henderson
Sr. Director Regulatory Affairs
Myriad Genetics, Inc.
我们的伴随诊断服务
涵盖诊断器械和药物产品的全面CDx支持。
器械支持
我们在器械开发方面的服务涵盖战略指导、项目管理和综合运营支持：
为什么选择QbD IVD | Qarad？
Your single partner for the full CDx lifecycle
Integrated drug–diagnostic expertise
one team managing both pharma and IVD regulatory pathways for seamless co-development.
End-to-end CDx support
from biomarker strategy and clinical performance studies to IVDR submissions and post-market compliance.
Sponsor delegation confidence
full compliance, visibility, and strategic alignment under IVDR and CTR while you retain overall oversight.
Industry-leading client portfolio
supporting 8 of the world's top 10 IVD companies and partnering with 11 of the top 20 pharma companies on CDx programs.
