Study File Setup

TCA's highly qualified team has the skills, knowledge and hands-on experience to complete key set-up tasks so the clinical trial can begin on a solid footing. TCA-designed studies strictly conform to the most rigorous standards and guidelines (including GCP standards as required by the CHI guidelines), whilst skillfully navigating all regulatory complexities. The clinical research protocol is the source for all data and resulting knowledge produced during the study. TCA demands extreme precision to avoid any protocol errors that could harm all the information systems and subsequent research operations (such as data collection, trial management, data analysis and reporting systems). All key documents and discussions with sponsors and investigational sites are documented at the most initial stages for the early identification of any potential issues. Additionally, all trial management and monitoring details are processed throughout the trial to ensure full transparency and readiness for an external audit.