EN
UnionClin provides independent imaging evaluation (IRC) professional services for clinical research of innovative drugs (subsidiary of UnionClin: Union Image). We have a professional medical imaging service team, with all members from imaging departments of domestic Grade III Level A hospitals, including over 300 senior image-reading experts from Grade-A Tertiary oncology specialized hospitals or Grade-A Tertiary general hospitals. With the self-developed imaging evaluation system as of U-ORBIT, online full-process image review activities can be realized, achieving 100% system traceability to ensure a complete audit trail. By establishing comprehensive standard operating procedures (SOPs) and strict quality control standards, the risk of result deviation is effectively reduced, data quality is improved, and the approval of NDA can be accelerated.
Project initiation consultation
Evaluation strategy consultation
Development of evaluation methods for study endpoints
Development of collection standards
Blinded Independent Central Review (BICR) for drugs and devices
RECIST1.1
mRECIST
iRECIST
PCWG3
IMWG2016
RANO
RANO-BM
Lugano2014
IWG2007
Volume contouring WORMS scoring
Liver fat fraction measurement (MRI)
Forrest classification
Mayo scoring
Lesion volume measurement
Wrinkle scale scoring
AD diagnosis and treatment criteria
MS diagnosis and treatment criteria
NMOSD diagnosis and treatment criteria
Expedited confirmation of enrollment eligibility (Optional)
Expedited confirmation of PD exit (Optional)
Reconciliation
Screening and training of independent evaluation experts
Quality control of imaging data
Quality inspection and bias analysis of evaluation results
Analysis of discrepant cases
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