刘晓婧
商务经理
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7th Floor, No 868 Changshou Road, Shanghai,China
Pixel Wiser
Founded in 2022. Pixel Wiser is an Independent Review Committee service provider (IRC) established by an experienced industry team, aiming to be in China and for global. Pixel Wiser has a seasoned team from top companies in the industry. The average working experience of the team exceeds 10 years. The team has more than 200 IRC trial experiences, mainly in oncology, and has been involved in more than 50 drugs which have been approved by global major regulatory such as FDA, EMA, NMPA, and PMDA. Pixel Wiser is a reliable partner on your pivotal trials with high service quality and seasoned industry experience. Pixel Wiser has 2 validated data hubs in Ireland, EU and China, APAC to support Multiple Regional Clinical Trials (MRCT).
10+ years industry experiences in BICR project management
200+ BICR Project experience in clinical trials
50+ Drug approval records in different regulatory
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%
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