Varian announced on May 9 that it has signed a cooperation agreement with Shandong Cancer Hospital in China, on proton therapy clinical application and research.
Varian has selected Shandong Cancer Hospital which is to equip a new multi-room proton clinical research center with Varian’s ProBeam proton therapy system. Varian said it will also install its Aria oncology information management system and Eclipse treatment planning software,
In addition, Varian is to create a proton clinical training school, develop proton therapy clinical application guidelines for NMPA (CFDA), and conduct research on Big Data and AI, as well as Flash therapy, which represents the potential for a major breakthrough in the treatment of cancer.
ChinaMed Device, LLC has extensive knowledge about Proton Therapy and accelerators. We provided the whole clinical package and conducted clinical trial for United Imaging, the leader of China domestic accelerator manufacturer, for its world’s first integrated CT-LINAC. NMPA (CFDA) innovation pathway approval was granted within 12-month without a supplementary request. Please see our success HERE.
Highlights from this clinical trial:
- Recruited 70 late-stage cancer patients in three sites;
- Overcame the challenges of recruiting and coordinating between different cancer patients and investigators from different therapeutic areas;
- Effectively and efficiently helped United Imaging align the imaging and radio therapy equipment.
We have translated the NMPA (CFDA) Clinical Evaluation Guideline on Proton and Carbon Ion Therapy System. We charge nominal fees for the English version. info@ChinaMedDevice.com.
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About ChinaMed Device, LLC
ChinaMed Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for western medical device, IVD, CDx and combination products to enter China. As a certified NMPA (CFDA) legal agent with offices in Boston and Beijing, we can represent overseas manufacturers for the complete product life cycle without their need to set up local entity in China. Our NMPA (CFDA) regulatory services include: RA, regulatory strategy, regulatory submissions, clinical evaluation reports (CER), clinical trials, QA, GMP and post-market compliance. Our commercialization services include: market assessment research, reimbursement, partnership strategies, and distribution qualification.