Clinical trials are continuing to become more of a bottleneck to get products to market. As more and more products are having difficulty in the marketplace, more and more data will continue to be required to ensure the product is safe for patients. As these needs become more prevalent, current issues such as inefficient processes, poor performing sites, and lengthy clinical study report generation processes. will become exacerbated and cause even more significant delays.

It is common knowledge in the industry that about 80% of all clinical trials do not meet their original planned dates for completion. This is largely due to a lack of predictability in the Last Patient First Visit milestone. HighPoint Solutions has personnel who are skilled in setting up controls and predictors for this and other critical trial milestones.

It is imperative that the clinical enterprise architecture reflects a target state that is 100% aligned with the business goals and drivers. This is true of any enterprise, however HighPoint Solutions has personnel that understand the true target end state for a clinical enterprise. Our fully mature vision incorporates CDISC standards, business process management, service oriented architecture, portal technology, and business intelligence in a way that is completely driven by the business goals yet will reduce total cost of ownership by preventing vendor lock in.

HighPoint has researched several clinical Key Performance Indicators through our experiences that has led to the creation of several Clinical Dashboards. These dashboards allow for different source information to be integrated, and provide a coherent structure for analysis and reporting. Clinical Dashboards can illustrate enrollment/site tracking, protocol compliance and data tracking of IND to NDA performance for a specific product.