Key points and risk prevention and control in cooperation on sample testing of drug clinical trials between pharmaceutical companies and third-party testing institutions
DUAN Wen-tao
WANG Chong-yu
DENG Yong
Abstract：Objective:To provide a reference for the compliance management of sample testing cooperation between pharmaceutical companies and third-party testing institutions in drug clinical trials.Methods:Based on the actual practice of sample testing cooperation in drug clinical trials,this paper analyzes the core points and potential risks in the cooperation from the perspectives of cooperation key points and risk prevention and control,and proposes targeted prevention and control strategies.Results:Overall,non-compliant behaviors in the cooperation may expose both parties to civil liability,administrative liability,or even criminal liability.From the perspective of cooperation practice,pharmaceutical companies and third-party testing institutions generally face problems such as vague definitions of service content,unclear division of rights and obligations,and insufficient quality control.From the perspective of the industry environment,drug clinical trials regulation is becoming increasingly stringent,with continuously rising requirements for the standardization of sample testing and data authenticity.Conclusion:In sample testing cooperation between pharmaceutical companies and third-party testing institutions,both parties should clarify the key points of cooperation,including refining the scope of services,standardizing expense settlement,defining the ownership of technological achievements,fulfilling confidentiality obligations,establishing a communication mechanism and adopting standardized entrustment agreements.They should also strengthen their awareness of risk prevention and control and improve their compliance management systems.At the same time,targeted prevention and control measures should be constructed against risks such as approval deficiencies,subcontracting,quality control failures,expense disputes,and intellectual property infringement,so as to ensure the quality of clinical trial data and the safety of subjects,safeguard the legitimate rights and interests of both parties,and promote the stable and orderly development of cooperation.
Keywords：drug clinical trialsample testingkey points of cooperationrisk prevention and controlcooperation agreementcompliance management
Publication Date：2026-06-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：8( 1288-1295 )