项目经理按照临床试验总体活动,生成项目预算列表,绑定质量标准,职责分工,可交付成果(达到这个意识和输出结果,Clinical Project Manager就合格,在目前企业可以拿到60万左右薪资;我认识到的一位顶尖CPM,目前拿220万人民币薪水)。最后,基于项目计划的所有考虑,团队...
记得若干年前,中国还没有一份中文版的临床试验管理计划书,英文版的计划书一看就不是真正的Trial Plan,全都是介绍流程和操作如何实施和执行的假计划书,而不是思考如何将一个品种从II-III期做完,考虑所有事项的工具表。 硬着头皮啃PMI天书,啃管理书籍,啃NIH、EMA,啃FDA关于方案开发和试验管理书籍,到后期的NHS册子...
记得若干年前,中国还没有一份中文版的临床试验管理计划书,英文版的计划书一看就不是真正的Trial Plan,全都是介绍流程和操作如何实施和执行的假计划书,而不是思考如何将一个品种从II-III期做完,考虑所有事项的工具表。 硬着头皮啃PMI天书,啃管理书籍,啃NIH、EMA,啃FDA关于方案开发和试验管理书籍,到后期的NHS册子...
临床试验 clinical trial 临床试验note · 4 篇内容 订阅专栏 如何做质控计划? Annual Quality Plan——质控管理计划,年度质量计划,年度行动计划?1) 计划时间: 在第一季度,或在上一年年尾酝酿; 2) 内容: Compliance training matrix 矩阵;宏观,承担职位的人按时按矩阵完成培训内容,未完成的地方在哪里? Project ...
“In a clinical trial, participants receive specific interventions according to the research plan or protocol created by the investigators. Clinical trials may compare a new medical approach to a standard one that is already available, to a placebo that contains no active ingredients, or to no int...
Our innovative clinical trial designs and types can help represent the right population of patients for generating critical data on your path to commercialization.
LINEA System applies cutting-edge technology and data to accelerate clinical trials with our Study Start-up Management System (SSMS), AcceleTrial™.
Acceptance criteria: The product specifications and acceptance/rejection criteria, such as acceptable quality level and unacceptable quality level, with an associated sampling plan, that are necessary for making a decision to accept or reject a lot or batch (or any other convenient subgroups of manufa...
Our Clinical Trial Managers (CTMs) ensure timely progress and overall quality of the deliverables for each trial. Working closely with our cross-functional project team, and other vendors, the CTM strategizes, plans, and coordinates all project activities to seamlessly execute the trial. Like the ...
“Your clinical trial management system name is very true — simple and intuitive, yet full featured and sophisticated behind the scenes.” –PROJECT DIRECTORWhat is a CTMS? The Clinical Trial Management System is the essential set of tools to effectively plan, manage and track your clinical stud...