The First Central Imaging CRO in China
China Medical Imaging Industry Leader, FAB has been highly recognized by customers for dedication and expertise, and has an excellent reputation.
由高级医学影像学专家组成的资深专家团队,且与ASCO、CCR 、RSNA、 ESR等专业协会保持良好的沟通交流。
团队成员具有超强的执行力,极快的反馈速度,专业的医学影像背景,丰富的影像科工作经验。
对造成IRC与on site 评价差异的影响因素,有独到透彻的理解、分析和实践经验,使试验质量得以保证。
对各种评估标准具有深入、细致、专业的解读并在相应适应症上正确应用。
具有自主知识产权的影像系统,符合FDA/NMPA法律法规要求,达到国际领先水平。
在药物审批方面,多次出席CDE沟通会,拥有丰富的审批沟通经验,对试验影像学层面提供全方位的管理和支持。
China Medical Imaging Industry Leader, FAB has been highly recognized by customers for dedication and expertise, and has an excellent reputation.
The expert team of senior medical imaging experts, strong training and professional reading techniques strictly control the reviewers and the quality of the readings.
Experts are highly experienced in assessment and have high stability with the variability between reviewers much lower than the industry average.
Project team has professional medical imaging background and rich experience working in imaging department, with efficient and immediate consulting ability and execution.
Differences in assessments between IRC and on site are well controlled within a reasonable range, and have a unique and thorough understanding, analysis and empirical experience of the factors.
The project operation is carried out in strict accordance with SOPs and complies with FDA/NMPA laws and regulations.
Understanding of clinical drug mechanism of action, accurate interpretation of criteria, and assessment results that provide real feedback on drug efficacy.
Imaging system with independent intellectual property rights, and complies with FDA/NMPA laws and regulations.
Regarding drug-approval, having rich experiences in attending CDE meetings and supporting approval of communication.