Yesterday we were happy to watch on our screens the first batch of laboratory samples of a clinical study involving several thousands subjects arrive at their final destination in a laboratory in the United States. The samples were taken from study participants in several hospitals all over Greece, collected and controlled in a central collection centre in Athens and from there dispatched to their final destination in the US. At each hop they were recorded and reconciled using our brand new sample tracking module of our clinical database system. We will be equally thrilled to see the lab upload their analysis results for automatic validation, reconciliation and integration into the clinical database of the study.
Our lab sample tracking software has been designed to allow sample data to be integrated with clinical data in all their life-cycle, from initial requisition, to dispatch and shipment, to receipt and integration of analysis results in the clinical database. The system allows recording of requisition, shipment preparation and receipt using barcode scanners, reconciliation at each step, detection of discrepancies and discrepancy resolution by the clinical study monitor. Since sample data are connected to the clinical database, data integrity is ensured and the burden of reconciliation minimised. A safe journey of samples instead of an Odyssey of data file exchanges and manual reconciliations.
Real-time indicators calculated for each storage location to support risk management, 21 CFR Part 11 compliant electronic signatures, audit trails, signed shipment manifests sent electronically, e-mail notifications, dataset downloads, allow the management and oversight of the entire process from initial requisition to validated results ready for analysis.
The system is an integral part of our eCRF / CTMS clinical software but has been designed so as to be able to be easily integrated with any third-party EDC software possessing an API for subject data retrieval.
Our next on-the-field endeavour will be the usage of the system in a large phase III survey we have undertaken, which will take place in several countries in Africa and requires several laboratory tests for each subject in different laboratories. But our development roadmap has milestones ahead: we are developing a dashboard of elaborate statistical indicators for early risk detection, an API for data exchange and a special version of the tool for IMP logistics and general trial logistics management.
For more information visit https://moneta.agilis.gr/r/o9S or e-mail [email protected].