Bioequivalence (BE) and PK/PD testing

Release time:2018-07-11 Source of the article:Bioequivalence (BE) and PK/PD testing

We offer high quality one-stop mimetic bioequivalence clinical trial (BE) services. There are full-time teams of medical writing, project management, data management and statistical analysis for BE and Phase I clinical project, and sample testing units in long-term cooperation with us. With our teams featuring strong technology and profound project experience, our projects have passed successfully more than 20 on-site inspections by the national and provincial divisions of the CFDA.
Service Scope
Basic document preparation for clinical trials (protocol, case report form, informed consent, etc.)

Preparation for site initiation (select site, organize investigator conference, apply for ethical review, apply for the review by China Human Genetic Resources Management Office, negotiate about and sign the contract with site, etc.)
Site Initiation and Training
Clinical Trial Monitoring
Clinical trial quality control and quality assurance
Site Close
Clinical Trial Project Management
Data management and statistical analysis
Clinical study report writing

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