RFI

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    Two people discussing and signing documents related to audits in clinical trials of medicinal products and medical devices. The discussion focuses on compliance with the valid law and guidelines concerning Good Clinical Practice (GCP). Audits are a crucial element of the quality assurance system that each Sponsor of a clinical trial must manage. SciencePharma’s team of qualified auditors, with extensive knowledge in clinical trials, conducts independent assessments at every stage of a project or study. Services include conducting systemic audits, verifying standard operating procedures, assessing potential vendors, processes or contracting activities, and audits associated with clinical trials during or after completion. To improve quality, appropriate preventive or corrective actions are proposed.

    GCP-药物临床试验质量管理规范

    根据有关药物临床试验质量管理规范(GCP)的有效法律和指南,药品和医疗器械临床试验中的审计是质量保证体系的重要组成部分,临床试验的每个赞助商都必须负责。

    SciencePharma拥有一支合格的审计团队,他们在临床试验方面拥有广泛的知识。所获得的经验使我们能够对开发项目/研究的每个阶段进行独立评估。

    我们提供系统审计,在此期间,我们验证标准操作程序和其他质量文件,评估潜在供应商、流程或承包活动,在临床试验进行期间或完成后进行与临床试验相关的审计。为了提高质量,我们可以建议引入适当的预防或纠正措施。

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      请注意,在上述表格中输入的个人数据的管理员是SciencePharma Sp. z o.o. 注册办事处位于Warsaw, Chełmska 30/34. 处理这些数据是为了接收收到的信件并对其作出回应。提供个人数据是自愿的,但对于发送表格是必要的。每个人都有权访问他们的数据并对其进行更正。

      您可以查看有关个人数据保护的详细信息点击这里.