Clinical trial sites are increasingly under pressure to increase the pace of drug development and reduce costs for sponsors, against a backdrop of increasing regulatory compliance. Inefficiencies in the local lab contribute to this through
- Inefficient and paper-based logs and processes
- Inability to manage and track samples within the lab, and with outside suppliers and couriers
- Difficultly in managing time-sensitive processing and storage of samples
- Inability to properly manage stock in freezers
- Excessive time expended manually reporting and logging samples for traceability and auditing.
HealthRFID’s ClinicalControl solution provides:
- Automation of manual processes at the local lab, including kit management, sample processing, storage and shipment
- Real time tracking of sample collection and processing, including interactive dashboards
- Short or long-term storage management
- Proof of delivery with real time tracking and alerts for samples within the lab and for outsourced testing
- Complete electronic audit trail of who completed every step in the process, and the journey of each sample
- Compliance with CFR 12 Part 11