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Medical Imaging

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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%.

Clinical medical imaging projects

Subjects

Timepoints