Lab Sample Tracking Tool
Agilis Sample Tracking Tool for clinical trials is a software allowing the efficient tracking of lab samples from initial on-site requisition from study participants, to delivery and collection by laboratories of sample batches, to receiving of analysis results from labs.
The system allows the tracking of individual samples at all points in their life cycle from clinical site to laboratory, the generation of formal documents such as electronically signed dispatch manifests and receipt forms as well as the detection and reconciliation of discrepancies.
The system can be integrated with the clinical database of a clinical study, ensuring data integrity, regulatory compliance and reducing the effort needed for reconciliation.
The functionality offered includes:
- Barcode-based sample requisition, with display of blinded subject reconciliation data to ensure correct assignment of subject id to sample code
- Handling of different types of samples according to the study protocol, different types of storage locations and different dispatch routes
- Real-time monitoring and reporting of samples kept in specified locations (such as clinical site, intermediate collection centre, laboratory)
- Real-time tracking of individual samples, dispatches etc.
- Preparation and logging of sample dispatches and generation of electronically signed dispatch manifests / shipment forms, with automatic e-mail notification of the site that will receive the sample batch.
- Bar-code based electronically signed batch receipt with detection of potential discrepancies between dispatch manifest and actual contents of the batch received as well as handling and reconciliation of discrepancies, marking of damaged samples etc.
- Upload of analysis results by the laboratory in predefined electronic formats, checking and reconciliation of results and linking to the clinical database.
- Chain of custody of samples
- Detailed definition of user access rights depending on user role
- Detailed reporting and monitoring
The system is compliant to 21CFR Part 11 regulation for electronic records and electronic signatures.
Agilis Sample Tracking Tool is provided as a Cloud Software Service in a secure ISO 27001 certified technical environment ensuring data protection, confidentiality and security. The software is developed according to our ISO9001 certified and audited Software Development Life Cycle (SDLC) procedures and is validate to ensure regulatory compliance to clinical trial regulations.