Sponsor companies, investigators, and contract research organizations are challenged to reinvent the clinical trial logistics for innovative and complex trials. A trend towards patient centric clinical trials and the need for shorter time to market has resulted into development of individualized therapies requiring Direct-to-Patient delivery of clinical trial medication. Advanced solutions are needed for controlling the investigational medication during shipment and storage from bench to the patient, while adhering to compliance regulations.
AntTail offers a state-of-the-art IoT solution for the monitoring of investigational medication by applying fully automated wireless sensors that are small and easy to use, fitting inside patient kits or larger shipment boxes. Data reports, medication location and arrival information are directly available to Sponsor companies, investigators and contract research organizations. Compliant shipment and storage data is being collected automatically in a protected cloud environment, the AntCloud. The AntCloud enables central oversight of investigational medication that is stored at the sites, at patients or in warehouses/storage depots.
AntTail sensors in clinical trials
AntTail sensors can be included in a patient kit or medication box. They monitor temperature during the complete logistic chain, from packaging up to and including storage at the patient’s home. Real-time temperature data is obtained easily by gateways that are placed at packaging, manufacturing, warehouse or clinical sites. In addition, the smartphone app can be used to obtain and synchronize the data. Optionally, a lux sensor (ANTlux) can be added in the box to monitor box integrity or adherence.
When a shipment arrives at a clinical site or at a patient’s home, the patient or healthcare professional can use the smartphone app to read out the sensor and generate the shipment delivery report. After scanning the patient kit barcode label, encrypted sensor-data is read out directly and sent to the AntCloud where alarm evaluation takes place. Results are shown on the smartphone and directly sent to other stakeholders.
Regulations for clinical trials require a documented temperature control for the storage of investigational medicinal products. The audit trail serves as evidence for compliance of the temperature conditions and should cover the clinical supply chain from manufacturer to the patient and, during storage at the patient’s home. Compliance and audit trails are easily generated with AntTail’s solution with the following advantages:
- 24/7 Storage monitoring via gateway’s
- Shipping reports readily available
- Control over alarms & stability budgets
- Central information acces via AntCloud
- Automatic read out of sensor data and collection of data in the AntCloud, i.e. no time-consuming human actions required to obtain all data extracts from USB loggers.
- No need to puzzle with different and multiple sensors of different locations, all temperature data for a patient kit is available in one central location.
- Data storage in the AntCloud is compliant with CRF 21 part 11 making storage traceable. Data manipulation is impossible.