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NoyMed Corp. offer service "Data Management"

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基本信息

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子类别与细分类别

交易类型

提供服务

服务名称

Data Management

服务提供商

规格参数

  • 研究类型: 覆盖研究全生命周期的临床数据管理,从方案审查、CRF设计到数据库锁定
  • 监管合规性: 数据核查计划、edit/SAS检查程序设计及eCRF填写指导,符合GCP数据完整性要求
  • 数据管理系统: eCRF规范及程序设计,包含数据集提取、审查及结构化数据审查计划

其他信息

补充描述:

The clinical data management offering spans the full study lifecycle. Start-up work covers protocol review, CRF creation, building the data management plan, and database setup — eCRF specification and programming, a data validation plan, edit/SAS check programming, dataset extraction and review, eCRF completion guidance, and a data review plan. Once the database goes live, site training follows. During the conduct phase, the team handles single and double data entry with validation, data cleaning, query management, serious adverse event reconciliation, and the integration, verification, and reconciliation of external data, plus data transfer agreements and medical coding against WHODrug and MedDRA. Closing activities include database lock, database finalization, resolving outstanding queries, collecting eCRF e-signatures, approving medical coding, completing documentation, producing CDASH-compliant exports and reports, and final database lock and archival.
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NoyMed Corp. offer service "Data Management" | PharmaCountry