quality and efficiency of clinical trials.
The Investigational Plan describes not only the essential background documentation related to the test article and procedural aspects of a study, but also defines how ethical and regulatory considerations will be managed during the course of the study. The CTTI Projects that fall under this category focus on innovating this preparatory phase of the clinical trial process.
Study Start-Up describes all of the activities associated with identifying, qualifying and activating investigational sites. The CTTI Projects that fall under this category are concerned with site level regulatory approvals and preparation of the site for successful enrollment.
Study Conduct describes the active data collection phase of an investigation in which patients, sites and sponsors interact to test the safety and/or efficacy of the investigational article. The CTTI Projects that fall under this category are concerned with monitoring and transfer of safety data between sites and sponsor.
Analysis and dissemination describes the phase of an investigation in which data is cleaned and analyzed, then presented and published in the public domain. The CTTI Projects that fall under this category analyze data output from clinical trial research, identify areas of improvement and focus on the dissemination of clinical trial results to the scientific community and public.