Team Expertise
Avg. 10+ years industry experiences; 200+ BICR Project experience; 50+ Drug approval records in different regulatory; 100% certified image management and medical affairs team memebers.
Sparkle Platform
SaaS architecture, centralized cloud deployment, global access; End-to-end integrated modular workflow management ensures complete data integrity and full traceability; Fully compliant with GCP and 21 CFR Part 11; User-friendly interface.
Quality Assurance Mechanism
Complete closed-loop management of imaging data flow and read quality control; Sparkle automatically detect and identify suspicious cases; Full-scale read quality control by a professional medical team; All members of the medical team are seasoned radiologists.
Reader Pool
Over 300 experienced Chinese and global read experts; The readers are mainly associate directors and directors; All readers have passed Pixel Wiser qualification tests and undergo regular training.
Happy Clients
Expereineced team served more than 60 clients; diversified clients including MNC, Biopharma and Biotechs; 60+ NDA inspections by different regulatory; Repeat Collaboration rate more than 83%