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
- Tumor Volume or Area Calculation
- Organ volume Measurement
*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%.