Project Management

Performance indicators permit focused monitoring, prompt remedial action and on-target completion.

Traditional site monitoring is often one of the least efficient components of large clinical trials, typically consuming up to a third of study budgets. Our systems improve on traditional monitoring by allowing for more intense monitoring when warranted by performance indicators such as the quality and quantity of data from a site and its query response time. This approach permits close attention to lagging sites, identification of problems in days rather than months, and prompt remedial action when necessary.

Our proprietary in-house monitoring software, Smart Monitor, optimizes the functions of assuring GCP compliance and source data validity while focusing on project management at the site level. By relieving monitors of many tedious tasks, Smart Monitor allows monitors to focus on building relationships with site personnel, training staff to address common errors, and proactively managing the study rather than merely reacting to problems after they become apparent.

The timely flow and rapid processing of incoming information allow monitors to function more effectively as site managers, focusing their efforts on the most strategic issues. Up-to-date site performance information, such as enrollment, safety data and query rates, is available 24/7 over the web, and is benchmarked against projected performance for the individual site and actual performance of other study sites. Additional site-specific information and metrics can be made available on request.