Article(id=1321425723517161552, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425717926154257, articleNumber=null, orderNo=null, doi=10.20251/j.cnki.1003-3734.2026.12.008, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=1753804800000, acceptedDateStr=2025-07-30, onlineDate=1792982043389, onlineDateStr=2026-10-26, pubDate=1782748800000, pubDateStr=2026-06-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1792982043389, onlineIssueDateStr=2026-10-26, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1792982043389, creator=13701087609, updateTime=1792982043389, updator=13701087609, issue=Issue{id=1321425717926154257, tenantId=1146029695717560320, journalId=1235980733773295621, year='2026', volume='35', issue='12', pageStart='1233', pageEnd='1344', issueExtLink='null', onlineDate='null', pubDate='1782748800000', pubDateStr='2026-06-30', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1792982042056, creator='13701087609', updateTime=1792982988069, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1321429686186529703, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425717926154257, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1321429686186529704, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425717926154257, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1288, endPage=1295, ext={EN=ArticleExt(id=1321425723693322321, articleId=1321425723517161552, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Key points and risk prevention and control in cooperation on sample testing of drug clinical trials between pharmaceutical companies and third-party testing institutions, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
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.
, authors=Wen-tao DUAN, Chong-yu WANG, Yong DENG
*, authorsList=Wen-tao DUAN, Chong-yu WANG, Yong DENG, authorCompany=null, correspAuthors=Yong DENG, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1321425723978534995, articleId=1321425723517161552, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=制药企业与第三方检测机构开展药物临床试验样本检测合作要点与风险防控探讨, columnId=1236331741447778310, journalTitle=中国新药杂志, columnName=药物临床试验规范与进展专栏, runingTitle=null, highlight=null, articleAbstract=
目的： 为制药企业与第三方检测机构在药物临床试验样本检测合作中的合规化管理提供参考。
方法： 结合药物临床试验样本检测合作的实际情况，从合作要点和风险防控角度，剖析双方合作中的核心要点与潜在风险，并提出针对性防控策略。
结果： 总体来看，合作中的违规行为可能使双方面临民事责任、行政责任甚至刑事责任。从合作实践来看，制药企业与第三方检测机构普遍存在服务内容界定模糊、权利义务划分不清、质量控制不足等问题。从行业环境来看，药物临床试验监管趋严，对样本检测的规范性和数据真实性要求不断提高。
结论： 制药企业与第三方检测机构在样本检测合作中应明确合作要点，包括细化服务范围、规范费用结算、界定技术成果归属、落实保密义务、建立沟通机制及标准化委托协议，应强化风险防控意识，完善合规管理体系。同时针对审批缺失、转包分包、质量失控、费用争议、知识产权侵权等风险构建针对性防控措施，以保障临床试验数据质量与受试者安全，维护双方合法权益，推动合作稳定有序开展。
, authors=段文韬, 王崇宇, 邓勇
*, authorsList=段文韬, 王崇宇, 邓勇, authorCompany=null, correspAuthors=邓勇, authorNote=
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段文韬，男，硕士研究生，主要从事公共卫生政策与法律研究。联系电话：（010）53912328，E-mail: duanwentao4089@163.com。
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段文韬，男，硕士研究生，主要从事公共卫生政策与法律研究。联系电话：（010）53912328，E-mail: duanwentao4089@163.com。
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