必赢亚娱乐官网(中国)有限公司

您当前位置:奥咨达医疗器械服务集团 >> 资讯中心 >> 医械常识 >> 浏览文章

【奥译言】CRO选择有困难?以下技巧助你解决选择难题

阅读: 2017年04月07日

【奥译言】CRO选择有困难?以下技巧助你解决选择难题


将所有或部分临床试验活动外包给合同研究组织(Contract Research Organization, CRO)会带到很大的优势。对于申办方而言,如果只有一名或几名内部员工专门从事临床活动,又或者员工缺乏合适的经验来有效管理一项完整临床试验,那么,外包服务供应商可能会有所帮助。但是,如何选择最适合自己的临床试验的CRO呢?

作为一名临床监查员,我曾与几个申办方和CRO企业合作,并亲身体会到,CRO和申办方之间配合良好不是理所当然的。语言和学问障碍、企业特定程序和习惯、可用资源、企业规模等各种各样的因素都可能对申办方和CRO的关系产生影响。好的CRO甄选过程可以帮助申办方避免其中一些困难。让大家看一下这个过程都包括那些内容吧。

 
申请


像处理新员工工作申请流程一样开始CRO的选择过程。在某种程度上,就像是通过外包的形式增加“员工”到项目当中。该一过程是有可比性的。在工作描述中,你提到了该项工作的职责和任务以及你所要求的技能和资质。你会发现,选择CRO也要进行同样的步骤。

 
关系


与CRO企业的合作最好是长期的,或者持续到整个试验过程。两者都必须愿意投资时间和精力到这段关系中,去了解对方的习惯和程序。你可能更倾向于与专门负责你试验的同一联系人进行沟通。员工流失率高会带来不利的影响。要敢于询问CRO企业的员工流失率以及过往的经验。通过这些问题的回答,就能发现你对这段关系和投入意愿的直觉。

 
资质


大型CRO企业可以提供广泛的服务,但这些服务你全都需要吗?一些CRO在世界各地均设有办事处;你需要在2个欧洲国家的5家中心开展临床试验吗?另一方面,如果你的监管策略是在中国收集数据,那么,你的CRO在中国也应设有办事处。就好像工作申请一样,你不会选择不合资格的员工,但选择资质过高的员工也有不利之处。这同样也适用于你的CRO企业。找多个CRO企业,询问他们能够提供哪些服务,以及他们将如何提供这些服务。审查他们的处理方式是否符合你所指定的职责、技能和资质以及你的企业学问。 

 
完成交易


最后一个要点是,成本。成本是选择CRO的重要标准。对申办方来说,重要的是要合乎现实。要客观地考虑工作量。如果你自己进行所有的活动,这也是需要资源的。

CRO提供的服务过多可能会增加项目不必要的支出;CRO的资质不够或者所提供的服务太少也可能在低价格上显现出来。当然,范畴和内部管理决策可能会起到一定的作用,特别是在成本方面。根据以往的经验,我知道申办方和CRO配合不好会增加整个项目的成本。例如,(大型)CRO企业根据其特定的SOP开展活动,而这对于特定的小项目来说又是非必需的。又或者是申办方希望CRO进行某些未包含在合同的活动,那就需要修改合同了。  


如果你和你选定的CRO就任务、职责和成本达成协议,必须在合同中列出这些所有内容。什么活动委托给CRO企业?谁负责什么?其中包括:保密性、进度计划、费用等等。毫无疑问,合同是很重要且有价值的,也是绝对有必要的。但实际上,如果你和你的CRO不仅不合拍,还出现困难,那么,合同也不能化解困境。信任、团队协作与沟通是关键词。

总而言之,对于你的临床试验来说,存在着许多有利及不利的因素。其中一些因素很难改变,但选择一个好的CRO企业是一个至关重要的过程。不仅对你目前的试验很重要,更是建立一种基于信任和友谊的长期关系。

如果外包已经是或即将成为你组织内的普遍活动,那么,编写外包流程和供应商订约方案的标准操作程序(SOP)将会是一个很好的方法。使用表格和检查清单来引导并记录决策的形成。在项目结束时与你的CRO一起实行评价活动。双方一起讨论进展顺利的地方以及未来可以改善的方面。

与工作申请一样,如果你的投资是长期、合适、高质量且具有竞争力的,你也会感觉到心满意足。


英语原文    


CRO selection a hurdle? Not with these tips to support a smooth selection process

Outsourcing all -or some- of yourclinical trial activities to a contract research organization (CRO) can havelarge advantages. If you, as a sponsor, only have one or few internal employeesdedicated to clinical activities, or have employees lacking the rightexperience to efficiently manage a complete clinical trial, a vendor can behelpful. But how do you select the one that fits your trial best?

 

Asa clinical research associate I worked with several sponsors and CROs andexperienced that a good CRO/Sponsor fit is not for granted. Language andcultural barriers, company specific procedures and habits, available resources,company sizes, all kind of aspects can have influence on the Sponsor/CROrelationship. The Sponsor can prevent some of these difficulties byimplementing a good CRO selection process. Let’s walk through this processstep-by-step.

 

The application

Approachthe process of CRO selection in the same way you approach a job applicationprocess for a new employee. In some way you are adding ‘employees’ to yourproject by outsourcing, so the process is comparable. In a job description youdescribe the responsibilities and tasks of the job, skills and qualificationsyou require. You will find yourself doing the same for CRO selection.

 

Relationship

Thecooperation with your CRO will preferably be long-term, or at least theduration of your trial. You both have to be willing to invest in therelationship, getting to know each other’s habits and procedures. Probably youprefer to communicate with one and the same contact person dedicated to yourtrial. High staff turnover rates are unfavorable. Dare to ask for turnoverrates and previous experience. The reaction to these kinds of questions canalready give you a gut feeling about the relationship and the willingness toinvest.

 

Qualifications

LargeCRO’s offer a broad range of activities and services, but do you need all? SomeCRO’s are represented all over the world; is that necessary for your trial thatincludes 5 sites, located in 2 European countries? On the other hand, if it isyour regulatory strategy to collect data in China, your CRO should berepresented there as well. When you compare with the job application; you willnot select underqualified employees but selecting overqualified employees hasdisadvantages as well. The same applies for your CRO. Ask multiple CRO’s whatservices they offer and how they will deliver these. Review if their approachis in line with the duties, skills and qualifications you have specified andwith your company culture.

 

Closing the deal

Lastbut not least, the costs. Costs are an important criterion in CRO selection.Important for a sponsor is to be realistic. Consider the amount of work to bedone objectively. If you do all activities internally it will require resourcesas well.

 

Toomuch services offered can make the project more expensive than necessary, toolittle qualifications and services offered might be visible in a low price. Ofcourse there are boundaries and internal management decisions that might play arole, especially in costs. From experience I know that a poor Sponsor/CRO matchwill increased the costs throughout the project. For example because the(large) CRO performs activities according to their SOPs that are not necessaryfor the specific, small project. Or the Sponsor expects certain activities fromthe CRO but these were not contracted, which requires a contractamendment. 

 

Ifyou and your selected CRO agree on tasks, duties and costs you have to outlineall in the contract. What is delegated to the CRO? Who is responsible for what?Include; confidentiality, milestones, costs etc. A contract is important,valuable and an absolute necessity, no doubt. However, in practice, if you andyour CRO are not a good fit and difficulties arise, the contract will not savethe day. Trust, teamwork, communication and collaboration are the key words.

 

Tosummarize, there are many aspect that can support or weaken your trial. Some ofthese are hard to change, but a good CRO selection is a vital process. Not onlyfor your current trial but also to build a long term relationship, based ontrust and companionship.

 

Ifoutsourcing is, or will become, a common activity within your organization itmight be a good idea to describe the outsourcing process and the vendorcontracting in a standard operating procedure (SOP). Use forms and checklist toguide and document the decision making. Evaluate together with your CRO at theend of the project. Discuss what went well and which aspects can be improvedfor the future.

 

Aswith the job application, you will be most satisfied if your investment is longterm, a good fit, of high quality and competitive as well.





内容来自: Qserve Group

整理翻译:奥咨达



奥咨达翻译服务

奥咨达翻译团队根植于中国,面向全球,专注为医疗器械领域的企业提供专业、高效的翻译解决方案。翻译领域包括医疗器械的研发、注册、临床、上市后监督、营销、管理、培训等,译稿已涵盖医疗器械领域的所有类型。


奥咨达翻译组联系方式:

邮箱:trans@osmundacn.com





(编辑:佚名 来源:本站原创)
分享按钮:
上一篇:《医疗器械网络安全注册技术审查引导原则》延伸解读(1)——App分类
下一篇:您准备好了吗?医疗器械免费检测,要求更高!

常用查询

    评审进度查询       |         医疗器械标准目录库       |         临床试验机构目录库       |         检测中心承检目录库

    医疗器械分类目录      |       医疗器械检测中心受检目录      |      国产必赢亚娱乐官网查询      |       进口必赢亚娱乐官网查询

更多>>

专家解读

奥咨达服务项目流程

临床试验
体外诊断试剂
进口注册
中国注册
质量管理体系
医械咨询
欧盟CE认证
美国FDA注册
海外注册
  • 经验丰富

    3000+医械客户,标准服务

  • 安全保障

    签订业务合同,资料专人管理

  • 合作无忧

    200+专业顾问,保质完成服务

  • 信誉卓著

    高新技术企业,信誉保障

  • 必赢亚娱乐官网|必赢亚娱乐官网

    XML 地图 | Sitemap 地图