CTMS
clinIT’s CTMS is an internet platform fully integrated in our EDC system and linked with the IVR/IWR System, IMP logistics, all data collection, data management processes and reporting system.
The CTMS tracks, schedules and manages virtually all clinical operations activities from the first to the last contact to investigational sites, including all regulatory processes, site monitoring and IMP logistics.
Our CTMS enables your team to conduct clinical studies very efficiently and facilitates optimal integration of essential QC processes and QRM, including
- Site feasibility and selection, pre-study activities and site initiation
- Management of essential documents and forms
- Recruitment status surveillance
- IRB/IEC and HA submission and approval processes
- Site monitoring and SDV, including reporting of all site activities
- Data management and query management
- Site close out activities and data base closure
- Drug supply, on site drug accountability and drug return
- Management and tracking of patient fees and other payments
- Safety management and SAE processing and reporting
