Monitoring
C-TASC—as an independent organization—can effectively monitor client studies, including study quality control, clinical site visits, interim monitoring, adverse event (AE) reporting, data safety monitoring board (DSMB) reporting, AE comparison across treatment arms, and unmasking of study treatments.
We conduct site visits through the use of a specially developed in-house technology: the Site Visit System (SVS). Through this system, our team has virtually eliminated paperwork from the site visit process, integrated site visit work into the overall data management system, and reduced the typical site visit timeframe by 40% or more—all the while streamlining individual processes and simplifying the overall procedure.
Our staff of highly experienced CRAs and CCRPs conduct all types of site visits including site initiation and certification, audit and study closeout.
We also have experience acting as an independent DSMB analysis center including managing the counting process for adverse events and sequential analysis of primary endpoints.