CSA

CSA

Enabling more insightful clinical trial reviews

Monitoring and reviewing clinical trial data is a critical step to ensuring the success of any clinical development plan. But today’s manual processes can often result in errors, compromising data quality and incurring costly study delays.

Medidata Centralized Statistical Analytics (CSA) provides immediate insight into clinical trial site performance and data quality. An integral part of Medidata Clinical Cloud, CSA integrates data from different systems and provides a comprehensive report for each subject, making it easier for teams to detect and track critical data changes throughout trial execution. 

The advanced and robust statistical algorithms in Medidata CSA provide a comprehensive scan of a clinical trial database for inconsistencies across data domains, sites and patients. With templates for SDTM data, automated processes can be setup so that every clinical study submitted to the FDA can have a study grade calculated for data quality. The overall study grade can be a measure of overall data consistency, and be compared across sponsors, studies, indications and disease areas. Individual site grades can be used to measure data quality within the site, and identify studies and sites at high-risk for procedural problems and data errors.

作为战略咨询服务副总裁,Rajesh Patel 领导一个由行业经验丰富的咨询顾问组成的全球化团队,通过战略服务和转型服务最大限度地增加 Medidata 客户投资的价值。

Rajesh 具有超过 24 年的多元化临床研究和开发经验,职位涵盖临床运营、数据管理和咨询服务等。

在加入 Medidata 之前,Rajesh 曾在 eTrials、Covance、宝洁、诺华和葛兰素史克等公司担任不同的关键领导职位,专注于尖端技术解决方案在临床试验中应用。 

作为 Medidata 战略咨询部首席,Kyle 负责风险监查咨询。Kyle 拥有 20 多年的临床研究经验,是包括风险监查在内的运营效率模式领域公认的专家。

在加入 Medidata 之前,Kyle 是 Research Pharmaceutical Services (RPS) 的执行副总裁。任期内,他与大中型制药企业携手设计、实施和强化全球研究机构管理,并通过过程、技术和高级业务分析来监查各机构。在加入 RPS 之前,Kyle 领导赛诺菲的美国临床研究运营团队。

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