Recently, Fujian Cosunter Pharmaceutical Co., Ltd. announced that its innovative anti-COVID-19 drug, Taizhongding® (Atilotrelvir Tablets/Ritonavir Tablets co-packaged), with complete global intellectual property rights, has been conditionally approved for market by the National Medical Products Administration (NMPA) of China, offering a new choice for the Chinese people in combating the COVID-19 virus.
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source: Official website of the China NMPA】
As the deeply engaged participant in the clinical trial stage of this innovative drug, Clinflash is honored to collaborate closely with Cosunter, utilizing high-quality digital solutions and a professional service system to expedite the research and development process of this innovative drug, jointly providing differentiated therapeutic solutions for patients with COVID-19 infections!
During the research and development phase of of Taizhongding ®, Clinflash has provided digital system support including Clinflash EDC electronic data capture system, Clinflash IRT randomization and supply management system, Clinflash Safety pharmacovigilance database system, Clinflash ePAY clinical trial electronic payment system, and others. These systems are closely integrated, significantly enhancing project operational efficiency while also facilitating comprehensive validation of the drug's efficacy and safety, aiding in regulatory approval and establishing a solid data foundation for the market launch of this innovative product.
In the Phase III stage of Taizhongding ®, which coincided with the Chinese Lunar New Year, Clinflash's staff actively engaged in detailed communication with the sponsor's project team and site staff, fully comprehending the needs of all project stakeholders, diligently coordinating the time and processes for trial participants, thereby supporting the smooth progress of the project.
To ensure the supply of medication during the Spring Festival, Clinflash team not only provided ongoing training and guidance to the sites after the system went live but also actively coordinated the blinding of medication according to the protocol and SOP requirements,which enabled efficient collection of random dispensing data and drug inventory at each site. Additionally, when faced with urgent payment orders during the New Year's Eve holiday, Clinflash ePAY promptly completed the payment tasks, earning unanimous recognition and praise from the Cosunter team.
The successful launch of Taizhongding® symbolizes Clinflash's contribution to the advancement of pharmaceutical innovation. Up to now, Clinflash has facilitated the CDE approval of nearly 20 innovative drug projects and secured FDA verification for 3 trials, offering top-notch digital solutions and professional service support to pharmaceutical research and development enterprises worldwide.
In the future, Clinflash will continue to uphold the concept of " Striving for Excellence with Customers" continuously strengthen the construction of digital solutions and related professional service systems, and empower the research and development of various pharmaceutical products.