Computer-assisted method for adaptive, risk-based monitoring of clinical studies
US10489379B2 · kind B2 · utility
Inventor
Key dates
| Filing date | Jul 8, 2016 |
| Grant date | Nov 26, 2019 |
| Priority date | — |
| Expiry date | Dec 25, 2037 |
Classification
- Technology area (CPC G)Physics
- CPC primaryG16H70/60
- WIPO fieldComputer technology
- WIPO sectorElectrical engineering
Abstract
A method and system are described for continuously assessing the quality of field data in a clinical study, identifying clinical sites with weaker performance than other sites, and flexibly allocating resources to address the problems, including the need to send field monitors to a site. The sites are compared with respect to the number of database entries requiring verification, and a higher priority (for allocation of management resources) is given to sites that have generated higher numbers of unverified database entries. The invention is particularly useful in the conduct of adaptive clinical trials of pharmaceutical products.
Source: USPTO / EPO open patent data. Objective bibliographic and citation counts.