Clinical research is an important stage of innovative pharmaceutical product development, providing drug regulatory agencies (e.g., National Medical Products Administration, NMPA) with adequate safety and efficacy data from human studies to support New Drug Applications (NDA) or Biologics License Applications (BLA). Typically, clinical research includes four phases: Phase I trials are first-in-human (FIH) studies for safety and pharmacokinetics at multiple dose levels of a drug in a small number of patients or healthy volunteers ; Phase II determine the efficacious and safe dose in a moderate number of patients; Phase III trials generally include a large number of patients to confirm efficacy and safety of a drug and support marketing approval; and Phase IV trials including post marketing studies that further expand product features. Throughout the drug clinical development from Phase I to final marketing approval, the activities consist of trial design, investigator selection, communication and training, trial operation and data management, medical monitoring safety of trial subjects, data collection and management, data analysis and summary, and study report preparation. All clinical research activities are performed in compliance with Good Clinical Practice (GCP) and NMPA regulations.
The majority of Zelgen clinical team members have experience with global clinical trial design, operation, and management. Zelgen’s clinical team consistently applies high quality standards in every aspect of the clinical trial activities performed, makes safety and benefit to our trial subjects the first priority, as well as dedicates efforts towards successful collaborations with key opinion leaders, investigators, CRO partners and vendors. This ensures the development of safe and effective drugs that will benefit patients.
Zelgen Clinical Trial Subject Recruitment Information and WeChat Posting Platform
Multicenter Phase II Clinical Trial of Jaktinib Tablets to Evaluate the Safety and Effectiveness for the Treatment of Middle and High-risk Myelofibrosis
