生物统计泰格医药科技有限公司

技术服务详细描述

Biostatistics

生物统计

泰格医药的生物统计部门由国内最权威的生物统计学家主持，在数据管理和统计分析方面具有丰富的实践经验。作为泰格团队的重要部分，从方案设计开始，全程参与临床项目的管理，确保我们的服务准确、及时、高效地满足客户的需求。

数据管理部门拥有符合ICH GCP 和美国FDA 21 CFR Part 11 要求的数据管理系统，确保临床数据和统计分析结果精确、完整、可靠。

The Department of Biostatistics of Tigermed is headed by the former chief statistician of the SFDA Drug Evaluation Committee. As an important part of Tigermed, our experienced team of professionals in Data Management and Statistical Analysis are in-process-involved in clinical project and committed to provide accurate, timely, and cost-effective services to meet customer needs and support regulatory filing.

The validated Clinical Data Management system in Tigermed complies with ICH GCP and the US FDA 21 CFR Part II requirements, which ensures the accuracy, integrity and credibility of clinical data and statistical results.

数据管理

Data Management

建立符合ICH GCP 和美国FDA 21 CFR Part 11 要求，具有数据痕迹管理的数据库

Study Database Setup according to ICH GCP and the US FDA 21 CFR Part 11 (Electronic Records & Signatures)

数据双份输入

Double Data Entry

程序化数据检查

Computerized Edit Check

医学编码

Medical Coding

发疑问表并更新数据

Discrepancy Generation and Resolution

盲态审查、锁定数据

Blind Review and Database Lock

统计分析

Statistical Analysis

统计专家参与方案制定及样本量的估计

Statistical Considerations and Sample Size Calculation in Protocol Development

盲底产生和药物编盲

Randomization List Generation

制定统计分析计划书

Statistical Analysis Plan Development

编制SAS程序，生成统计学图表

SAS Programming of Statistical Tables, Listings and Figures

完成统计分析报告

Statistical Analysis Report Writing

统计学家对总结报告的审阅

Final Report Review by Statistican

Biostatistics

The Department of Biostatistics of Tigermed is headed by the former chief statistician of the SFDA Drug Evaluation Committee. As an important part of Tigermed, our experienced team of professionals in Data Management and Statistical Analysis are in-process-involved in clinical project and committed to provide accurate, timely, and cost-effective services to meet customer needs and support regulatory filing.

The validated Clinical Data Management system in Tigermed complies with ICH GCP and the US FDA 21 CFR Part II requirements, which ensures the accuracy, integrity and credibility of clinical data and statistical results.

Data Management

Study Database Setup according to ICH GCP and the US FDA 21 CFR Part 11 (Electronic Records & Signatures)

Double Data Entry

Computerized Edit Check

Medical Coding

Discrepancy Generation and Resolution

Blind Review and Database Lock

Statistical Analysis

Statistical Considerations and Sample Size Calculation in Protocol Development

Randomization List Generation

Statistical Analysis Plan Development

SAS Programming of Statistical Tables, Listings and Figures

Statistical Analysis Report Writing

Final Report Review by Statistican

Tel: +86-21-32503700-845

Fax: +86-21-32503707

E-mail: na.gao@tigermed.net

www.tigermed.net