Data Management Services

The Cell Therapy Catapult is managing the conduct of a clinical trial to test the early safety and efficacy of a cell therapy product in patients with ARDS. Data management services are required to cover standard clinical trial tasks (e.g. CRF design, database building and others) in compliance with ICH GCP.

Data to be collected during the study include adverse events, vital signs, safety laboratories, respiratory measures, exploratory blood biomarkers, hospitalisation data (number of days in ICU, days as in-patient, and days on ventilator). A data safety monitoring board will convene on approximately 4 occasions to review interim, unblinded safety data. Key study operational team members will remain blinded to treatment assignment until completion of the trial at which point full trial analysis will be performed with an addendum CSR generated