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Endpoint Clinical Enhances Audit Data Submission Compliance with Egnyte
技术
- 网络安全和隐私 - 端点安全
- 网络安全和隐私 - 安全合规
适用行业
- 生命科学
- 运输
适用功能
- 物流运输
- 质量保证
用例
- 租赁金融自动化
- 监管合规监控
服务
- 云规划/设计/实施服务
- 系统集成
挑战
Endpoint Clinical 是一家交互式响应技术 (IRT) 提供商,面临着在试验结束时保持数据完整性的挑战。该公司通常通过充当中间人的试验申办者向研究人员提供审计数据。然而,由于申办者在获得所研究产品的市场批准方面拥有既得利益,因此存在潜在的利益冲突,因此这一过程引起了对数据完整性的监管担忧。监管机构倾向于将审计日志数据限制为更中立的各方,以避免任何数据被修改以支持批准的可能性。然而,将发起人完全排除在流程之外并不是一个可行的解决方案,因为他们仍然需要对整个流程进行监督。 Endpoint Clinical 的任务是找到一种方法,在为申办者提供所需的监督而又不让监管机构感到不舒服之间取得平衡。
关于客户
Endpoint Clinical 是一家交互式响应技术 (IRT) 提供商,总部位于马萨诸塞州韦克菲尔德。该公司拥有 600 名员工,从事生命科学行业。 Endpoint Clinical 的客户参与临床试验,该公司的作用是在日益计算机化的临床试验环境中简化向研究人员和监管机构提供审计跟踪数据的过程。这样做的目的是为所有利益相关者实现更有效和准确的合规性。该公司面临的挑战是降低试验结束时数据完整性的风险,同时保持试验申办者的必要监督。
解决方案
为了应对这一挑战,Endpoint Clinical 与 Egnyte 合作构建了一个平台,使他们能够直接向研究人员提供审计跟踪数据,而无需申办者亲自参与。审计数据管理平台由 Egnyte 的云文件解决方案提供支持,具有三个主要优势。首先,它通过捕获可追踪、负责和完整的数据来确保 GxP 合规性,并提供对数据如何更改以及谁访问了数据的全面可见性。其次,它提供对特定于站点的数据的受控访问,并具有精细的权限控制,确保数据只能由适当的利益相关者以适当的方式访问。最后,它通过提供审计日志已分发给调查员的书面证据来让申办者安心,确认一切都在没有他们直接参与的情况下得到了正确处理。
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