Bioequivalence & PK/PD

Working together to promote the clinical research and development process of innovative drugs and devices

Bioequivalence & PK/PD

We provide high-quality one-stop replication of bioequivalence clinical trials (BE) services. There is a dedicated medical writing, project management, data management, and statistical analysis team for BE and Phase I clinical projects, as well as a long-term cooperative sample testing unit. The team has strong technical strength and extensive project experience; Successfully undergone over 20 on-site inspections by the National and Provincial NMPA in China.

服务范围

Service scope

● Preparation of basic clinical trial documents (protocols, case report forms, informed consent forms, etc.)

● Preparation before the launch of the center (screening of research centers, organization of researcher conferences, ethics declaration, application for personnel and heritage management, negotiation and signing of research center contracts, etc.)

● Research center launch and training

● Clinical trial monitoring

Clinical trial quality control and quality assurance

The research center is closed

● Clinical trial project management

● Data management and statistical analysis

● Writing clinical research reports