Clinical Trial organisations are looking to solve several current issues, including the need to increase the service levels provided to their sponsors, the need to increase efficiency through the automation of manual systems, and ensuring compliance with standards such as FDA: 21 CFR Part 11.
HealthRFID Specimen tracking system can be used to manage all facets of the supply chain from the setting up of the study, the management of the study, the collection of the tests through to the sponsor reporting. The system can provide seamless integration with other systems and provide the organisation with an audit trial for every test item, thus ensuring compliance with the relevant standards.
The HealthRFID Specimen tracking system enables:
- Efficiency – The system will provide a significant reduction in staff time associated with recording of specimen status changes, and all the associated manual paperwork. Through software business rules, the scanning of individual specimens and the provision of alerts and notification based on specific criteria, staff will have more time to focus on managing their processes and optimise sponsor service levels.
- Compliance – For the first time a full audit trial will be available for every test, and the studies will be updated in real-time thus ensuring compliance with all required standards.