Overview

For clinical trials (Phase I – IV) with medical imaging evaluation as part of efficacy endpoints, we offer specialized services of medical imaging efficacy assessment.

Imaging Modality and Disease Indication

• Modalities include CT, MRI, PET, PET/CT, SPECT, X-ray, DSA, US/Echo, Endoscopy and digital photos etc.
• Therapeutic Areas: Oncology, Cardiovascular Disease, CNS, Hematology, Musculoskeletal Diseases, Digestive Disease, Dermatology, Ophthalmology, Medical Device, Contrast Agent, etc. 

Scope of Service

• Imaging acquisition protocol design
• Medical imaging requirement consultation   
• Site imaging acquisition capability evaluation     
• Off-Site/On-site training and support
• Collecting images and performing imaging QC  
• Electronic anonymization system – LUX system for site’s imaging data transmission
• Real-time eligibility review for patient enrollment
• Consultation service for various efficacy evaluation criteria (e.g. modified RECIST)
• Independent Radiology Review Charter development  
• Customized designing and programming medical imaging EDC (IEES-Imaging Electronic Evaluation System) 
• Managing and conducting Blinded Independent Radiological Review (BIRR)
• Imaging data management planning
• Delivery of the imaging analysis results to client or pertinent trial approval agent
• Complete trial supporting documentation and audit trail

Features and Advantages

• Offering professional radiology guidance throughout the entire clinical trial
• Process strictly adheres to FDA/NMPA guidance 
• Standard oncology packages that significantly reduce development time and cost
• Multiple options of independent radiological reads for clients to meet their specific submission needs of the clinical trials
• Validated review systems designed specifically for client clinical trials
• Auditable and reproducible reviewing results
• Significant reduction of evaluation variability, and keeping a complete database record and  audit trail.
• Remote reading capability
• Working with designated clinical CRO closely to integrate all pertinent clinical information to ensure the reliable and accurate final trial results per associated criteria.

Independent Reading Criteria

• RECIST (1.0, 1.1) and modified RECIST
• Lugano / Cheson / IWGC99
• RANO
• WHO
• SHARP
• Tumor Volume or Area Calculation
• Organ volume Measurement
• Others

Project Experience

*As of Q1 2020

FAB has established strict and standardized SOPs and quality assurance system,  and has successfully submitted over a dozen projects to NMPA , with customer satisfaction up to 96%.