Faster, Better, Less Expensive: Data-Driven Clinical Trials Monitoring

Clintel identified a growing need in drug development: enabling clinical development organizations to comply with FDA draft guidance on risk-based monitoring principles.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.

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 They identified a growing need in drug development: enabling clinical development organizations to comply with FDA draft guidance on risk-based monitoring principles.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.