For clinical trials (Phase 1–4) utilizing medical imaging as a part of efficacy endpoints assessment, Tigermed offers specialized professional medical imaging services.
Imaging Modality and Disease Indication
? Modality includes 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 and managing independent imaging QC
? Anonymization electronic system – LUX system for site’s imaging data transmission
? Real-time image evaluation for patient enrollment eligibility
? Consultation service for the efficacy evaluation criteria (e.g. modified RECIST)
? Independent Radiology Review Charter development
? Designing and programming imaging EDC (IEES-Imaging Electronic Evaluation System)
? Managing and conducting independent imaging efficacy evaluation and analysis
? Imaging data management plans
? Delivery of the imaging analysis results to client or pertinent trial approval agent
? Complete trial supporting documentation and audit trail
? Offering professional radiology guidance throughout the entire clinical trial
? Process strictly adheres to FDA/NMPA guidance
? Standard oncology packages that significantly reduce developing time and cost
? Multiple options of independent reads for clients to meet specific end-points needs of clinical trials
? Validated review systems designed specifically for clinical trials
? Auditable and reproducible reviewing results
? Significant reduction of evaluation variability and keeping a complete database record and storage
? Remote reading capability
? Working with designated clinical CRO closely to ensure the reliable and accurate final trial results which incorporate all pertinent information.
Independent Reading Criteria
? RECIST (1.0, 1.1) and modified RECIST
? Cheson / IWGC
? Tumor Volume or Area Calculation
? Organ volume Measurement