Unionlab IRC has more than 60 imaging experts’ resources, including more than 50 professors, associate professors, directors and associate chief physicians, they all come from tertiary hospitals, and covering imaging, nuclear medicine, clinical and other professional fields. Unionlab has implemented the high-quality guidelines of FDA and CDE, and independently developed an intelligent triparties independent imaging evaluation system which called U-ORBIT. U-ORBIT complies with multiple evaluation standards, such as Response Evaluation Criteria in Solid Tumors (RECIST1.0, 1.1) and Response Evaluation Criteria in lymphoma (Lugano 2014).
Efficiently carry out standardized image data collection and transmission, subject information anonymization, image data quality control, server localization and 2+1 blind judgment reading, ensure the objectivity of data then accelerate the process of clinical research.
Sophisticated reading quality assurance strategy:
Carefully selected reading experts: GCP qualification preferred, project field and match tumor type.
Normative training: use of system training, evaluation standard training and project training.
Simulated reading: reading experts must complete the customized training test
Image charter writing
Screening of independent reading expert
Customized training for reading expert
Quality monitoring and deviation analysis of expert reading
Image data quality control
U-ORBIT system usage