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
舞狮争霸走势图 体彩十一选五怎么玩 痉挛无码番号 北京快乐8上下盘怎么玩 买新疆11选5技巧 浙江20选5基本走势图综合版 黑龙江p62 乒乓球比赛比分 泳坛夺金组选12 甘肃十一选五的开奖结果 3d最近30期开机 3d开机号 特殊服务有什么项目 河南快3走势图表500期 黑龙快乐十分开奖视频 重庆百变王牌开奖时间 楚天30选5开奖结果