技术
- 应用基础设施与中间件 - 数据交换与集成
- 平台即服务 (PaaS) - 应用开发平台
适用行业
- 生命科学
- 药品
适用功能
- 质量保证
用例
- 库存管理
- 监管合规监控
服务
- 系统集成
关于客户
Decibel Therapeutics 是一家成立于 2015 年的临床阶段生物技术公司。该公司致力于发现和开发用于恢复和改善听力和平衡的变革性治疗方法。作为一家成长阶段的生物技术公司,Decibel 一直是支持临床和监管运营、医学写作、生物统计学和数据管理团队的重要合作伙伴,它拥有一个存储库,用于存储从 CRO 收集并提交给 FDA 和其他监管机构的所有文档。该公司于 2021 年上市,严重依赖全球合同研究组织 (CRO) 网络来进行全面的临床试验。
挑战
Decibel Therapeutics 成立于 2015 年,是一家临床阶段的生物技术公司,专注于开发变革性治疗方法,以恢复和改善听力和平衡。随着公司的发展并于 2021 年上市,它越来越依赖全球合同研究组织 (CRO) 网络来进行全面的临床试验。这些 CRO 收集了各种数据,包括就诊时间和日期、检测结果、不良事件信息、患者状态等。收集的数据量巨大,需要一种解决方案,不仅能够确保从 CRO 准确获取数据,而且能够根据良好临床实践 (GCP) 对数据进行严格的治理。此外,该解决方案需要支持外部第三方之间安全共享临床试验数据。
解决方案
Decibel 将 Egnyte 部署为所有受监管文档的唯一事实来源。对于来自 CRO 的大型数据集,Decibel 使用 Egnyte 的安全上传链接,该链接与内部文件共享系统的其余部分分开。文件夹权限和链接到期日期用于附加控制。当 Decibel 参与小型学术合作时,它会利用 Egnyte 的文件结构来存储文档,而不是成熟的 TMF。 Decibel 团队还受益于 Egnyte 与 Microsoft Teams 等业务应用程序的集成。 Teams 内共享的任何文件最终均由 Egnyte 管理,因此保持合规性。两个平台之间的集成为该团队节省了大量时间,因为员工不再需要追着团队成员在 Teams 中寻找最新文档。
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