Audit

Audit

GCP audit is an indispensable part for a GCP compliant trial focusing on providing independent examinations of clinical trial related activities to assure that the data and reported results are credible, accurate and integral, and that the rights and confidentiality of subjects are protected.

VCRO provides both external GCP audits and in-house quality assurance audits for all VCRO research processes and services. Quality Assurance Unit (QAU) serves as an independent group within VCRO to help our clients meeting the international ethical and scientific standards of GCP.

For all VCRO services, QAU supports initiating, developing, implementing, maintaining, analyzing, and reporting clinical trials based on VCRO quality management systems to ensure all services meeting the standards of contracted items, namely, relevant VCRO SOPs, ICH guidelines, US FDA 21 CFR Part 11, US FDA 21 CFR Part 58, US FDA 21 CFR Part 312, OECD GLP, TFDA GLP requirements and applicable country regulations.

  • Phase I - IV GCP audits
  • Site audits
  • Investigational product labeling and packaging process audits
  • VCRO clinical database audits
  • VCRO bioanalytical laboratory GLP audits
  • VCRO operational vendor audits
  • Internal system and process audits
  • Essential documents audits
推拉棋牌下载 辽宁快乐12网站 天津时时彩计划软件一首页 bg视讯做假 浙江11选5 新疆11选5购买 期货风险控制策略 qq麻将游戏大厅 最火可以兑换现金麻将 体彩大乐透开奖结果 283打鱼李逵劈鱼外挂 斗牛比赛规则 五百万彩票官网 pc蛋蛋近500期走势图 辛运28赌单双技巧 陕西快乐10分走势图彩经网 皇冠体育平台