Faster, Better, Less Expensive: Data-Driven Clinical Trials Monitoring
Customer Company Size
SME
Region
- America
Country
- United States
Product
- Tableau
- Microsoft SQL Server
- Microsoft Reporting Services
Tech Stack
- Tableau
- Microsoft SQL Server
- Microsoft Reporting Services
Implementation Scale
- Enterprise-wide Deployment
Impact Metrics
- Cost Savings
- Productivity Improvements
Technology Category
- Analytics & Modeling - Data-as-a-Service
- Analytics & Modeling - Real Time Analytics
Applicable Industries
- Pharmaceuticals
- Healthcare & Hospitals
Applicable Functions
- Product Research & Development
- Quality Assurance
Use Cases
- Predictive Quality Analytics
- Regulatory Compliance Monitoring
Services
- Data Science Services
- System Integration
About The Customer
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 They identified a growing need in drug development: enabling clinical development organizations to comply with FDA draft guidance on risk-based monitoring principles.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.
The Challenge
Clintel identified a growing need in drug development: enabling clinical development organizations to comply with FDA draft guidance on risk-based monitoring principles.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.
The Solution
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.
Operational Impact
Quantitative Benefit
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