White Papers

Overview: Proponents of Risk-Based Monitoring (RBM) report a dramatic reduction in on-site monitoring costs. In addition to this cost reduction, data quality and quality oversight is significantly enhanced by effective RBM.

Overview: Study teams need to be able to access and analyze the diverse data generated in their trials in real time. That task is beyond the original remit of data warehouses but is right in the wheelhouse of data lakes.

Overview: Clinical trials are ever increasing in complexity and the regulatory bar is ever rising, so biopharmaceutical companies are turning to innovative businesses. Technological methods to address their challenges …

Overview: SAE reconciliation is a critical component of clinical trial processes, but it is time-consuming, complex and cumbersome. By improving the SAE reconciliation processes, study sponsors and CROs can drive efficiency, save time and money, improve data quality and ensure the safety of participants.