Faster, Better, Less Expensive: Data-Driven Clinical Trials Monitoring
公司规模
11-200
地区
- America
国家
- United States
产品
- Tableau
- Microsoft SQL Server
- Microsoft Reporting Services
技术栈
- Tableau
- Microsoft SQL Server
- Microsoft Reporting Services
实施规模
- Enterprise-wide Deployment
影响指标
- Cost Savings
- Productivity Improvements
技术
- 分析与建模 - 数据即服务
- 分析与建模 - 实时分析
适用行业
- 医疗保健和医院
- 药品
适用功能
- 产品研发
- 质量保证
用例
- 质量预测分析
- 监管合规监控
服务
- 数据科学服务
- 系统集成
关于客户
Clintel is a company that offers its industry expertise to help pharmaceutical, biotech, and medical device clients develop and launch products faster and more cost-effectively. The company was founded in 2003 and is headquartered in Westlake Village, CA. Clintel has a decade of experience offering electronic data collection system services for companies engaged in the clinical trials process. They identified a growing need in drug development: enabling clinical development organizations to comply with FDA draft guidance on risk-based monitoring principles. They saw the potential to develop easy-to-use tools that could also improve quality and significantly reduce costs.
挑战
Clintel identified a growing need in drug development: enabling clinical development organizations to comply with FDA draft guidance on risk-based monitoring principles. They saw the potential to develop easy-to-use tools that could also improve quality and significantly reduce costs. The FDA advocates alternatives to regular, frequent onsite visits and verification of all data, which involve costly travel and provide little added benefit. Instead, they recommend approaches that identify risks to patient safety by utilizing critical data elements gathered in clinical data systems as a method of determining which sites warrant additional attention from clinical research associates (CRAs). The problem lies in getting that information to the right people at the right time, and in their language. Despite these issues, spreadsheets have become the default report technology for many business users because they have simply had no other option.
解决方案
Clintel has developed a data analysis solution and services set that is currently rolled out to several customers conducting phase ll and phase lll studies. Clintel’s Tableau implementations connect to multiple data systems, including clinical trial management systems (CTMS) and electronic data capture (EDC) systems. The ability to connect to cloud data sources also plays a big part in the solution. Clintel is currently working with customers who prefer the cloud-based model as it limits their maintenance and equipment burden. Clintel analyzes customer data, creating Tableau visualizations that they can embed into customers’ SharePoint sites. User access is managed through Active Directory or Trusted Tickets, depending upon the customer’s preference. The solution is secure and 21 CFR Part 11 compliant.
运营影响
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