Research Direction
Creating innovative therapeutic solutions from in-depth understanding of disease biology
Phase I-IV clinical trials
Management and implementation of phase I-IV clinical trials in various treatment fields
Within the required time limit and reasonable research budget, carry out clinical trial project management and the implementation of all work, such as feasibility assessment, research center selection, research initiation, subject selection and retention, research center supervision and center closure process, etc.
Comply with ICH GCP, national regulations and relevant requirements and standards to ensure the high quality and compliance of clinical research implementation.
Risk based monitoring, such as centralized monitoring, sets different risk focus based on different treatment fields, different research designs and purposes and different research stages, in order to more effectively monitor and reduce risks.
Clinical trial preparation and supervision
Provide independent (third-party) trial supervision services for external clinical trials, including whole process supervision or specific supervision, such as self-examination and / or verification preparation
According to the requirements of the sponsor, provide services for the formulation of quality control plan, the formulation of quality control key points list and the implementation of quality control
Establish a reporting mechanism for serious quality problems to ensure the timeliness of necessary reporting and effective rectification and prevention measures
Value added services
Establishment of clinical operation related quality system and standard operating procedures (SOP), training of supervisors and research managers
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Contacts
Add: 5-6/F, Tower B, Chongxin Building, No.13, Hangfeng Road, Fengtai District, Beijing
Tel: 010-83141848
Email: pg@primegene.net
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