了解分散式临床试验中的供应商管理挑战（DCT，AKA混合和虚拟试验）- Insights From Our Labs to Yours

分散性临床试验（DCT）的声称益处包括加速入学，减少患者负担和改善保留率以及其他效率。将虚拟元素合并到传统的试用模式中，需要对支持这些努力的技术，平台和其他“较少”元素进行明确的愿景;但是，管理多个供应商的潜在挑战通常被忽视。本文讨论了当今不断发展的临床试验景观中供应商管理，审计和可扩展性的关键考虑因素。

跟踪分散临床试验中的供应商可行性（DCT，AKA混合和虚拟试验）模型

在DCT模型中，供应商不能被视为静态元素。就像他们支持的试验一样，供应商必须保持灵活性，并响应于调整他们的赞助商的特定要求。鉴于他们的服务可以代表研究的主要组成部分，例如监督患者的安全和隐私，数据收集和确保监护权的调查产品链，供应商可以对研究行为产生重大影响。

当CRO与供应商合同支持赞助商的DCT元素时，CRO必须履行尽职调查，并为供应商的绩效提供适当的供应商监督。为确保供应商可以满足监管标准并遵循最佳实践，CRO将执行审计，并确保适用于以下指导文件的协调：

While some of these documents are U.S.-centric, many trials also include global study sites. Vendors need to understand how specific regulations can affect their work across different countries and regions.

实现效益和limitation of audits

Vendor auditing is a detailed process carried out with appropriate due diligence to ensure that the vendors have the appropriate capabilities, skills and quality systems necessary to perform the services required. Following guidance documents can provide a good baseline for ensuring quality results, but in reality, an audit cannot cover all aspects of the vendor’s operations – it is only a snapshot at a single point in time.

The auditing process must also account for vendors that operate in multiple global locations. If a vendor utilizes the same Quality Management System in each location, this can assist the CRO to assess risk when overseeing global DCTs.

As DCT services continue to evolve, CROs will gain experience with these types of trials, but must keep pace with technological advances and align with input from regulatory agencies. CROs must also remain nimble to respond to ongoing assessments of vendors as they develop new systems, services or update current ones. Once qualified, a vendor can be requalified via questionnaires or remote auditing tools, but a CRO needs to determine which factors influence decisions to audit/assess onsite for any new vendor service.

Finding a balanced approach to auditing

审核的平衡方法可以通过对供应商的风险类别进行分类来应用基于风险的管理原则，以增加审计过程的效率。

高风险供应商与研究受试者/患者进行直接互动;它们负责收集有助于初级和次要疗效或安全变量的数据
Medium-risk vendorshave the potential to influence study conduct (e.g., translation vendors, equipment suppliers)
低风险供应商不要与患者携带或提供审判的数据。他们支持辅助任务（例如，会议规划师，广告商）

高风险的供应商通常需要一个人的审计。可以使用远程审计或调查问卷进行评估低至中等风险供应商，以帮助验证适当的进程，程序和文档控制系统到位。

即使供应商被认为是低风险，标准操作过程系统的组件，培训计划和质量管理系统仍然很重要。对于那些通过审计的供应商，它并不意味着未来的跟进是不必要的。项目团队的任何绩效问题或投诉都可以触发额外的审计活动。

Meeting increasing demands for services

随着DCT获得验收和流行的，对供应商服务的需求增加。学习赞助商和CRO必须考虑其合格的供应商的持续可用性。一些企业一直在获取供应商团体的独家使用，这可以在其他人中创造暂时的差距，因为其他人必须找到和评估新供应商。

Even with a reliable vendor, scalability is another consideration as the market grows. Some vendors handle their increased volume of work by hiring third-party groups, for example, to provide home health nursing or mobile phlebotomists.

Is the CRO then responsible for verifying the work of the third party as well and assuming the oversight and due diligence on behalf of the study sponsor? Will the CRO know if the vendor appropriately qualified their own vendors? To ensure milestones and deliverables are met, CROs need to understand the level of oversight taking place and determine if the depth of auditing performed within the layers of sub-contractors presents an inherent risk to the sponsor, the clinical trial and even the study subjects.

展望未来的分散临床试验景观

赞助商预计，当他们与CRO合作时，他们审判的所有合同方面都得到了管理，包括任何供应商及其第三方承包商。CRO需要找到一个可管理的方法来评估各方的各方，同时考虑到审判的审判分散要素。随着DCT的变得更加普遍，我们的行业需要准备好适应寻找合格的供应商的要求，并确保这些供应商可以与全球法规对齐，产生质量数据，随着需求规模并促进成功的审判。

在密卡斯，我们投资于制定严谨的供应商ID，资格和监督计划。我们的使命是我们管理赞助商的试验中的卓越执行。我们严格的方法将我们作为DCT思想领袖和合作伙伴的深入体验，以便识别和减轻您的计划风险。

要了解更多关于Covance如何帮助您建立分散的临床试验的效率，请访问景。com。

您还可以找到诸如案例研究，白皮书，科学文章等额外资源www.wfliji.com/DCTeducation。