Today, nearly 40 percent of all healthcare products are temperature sensitive (1). It is expected that eight of the top ten global biopharmaceutical products will require cold chain handling by 2020 (2). These sensitive products must be stored within a limited temperature range until their expiration dates to ensure they retain their effectiveness. Furthermore, many products, including those stored at room temperature (from 15°C to 25°C/60°F to 75°F), may require temperature monitoring as well, driven by stricter regulatory guidelines.
Traditional methods for shipment temperature monitoring involve USB or similar loggers which require the site staff to plug in the USB, download the PDF, upload or manually enter into the RTSM (Randomization and Trial Supply Management), also known as IRT (Interactive Response Technology) system. Site users must then email the CRA before the kit/shipment can be marked as damaged/quarantined/available. Multiple issues arise from this approach:
- Time spent on manual logger processing could mean less time for site staff to spend with patients
- Sponsors are finding site enrolment is increasingly competitive and sites prefer sponsors who “make their lives easier” by improving the arrivals process
- Lack of visibility of temperature excursions means less assurance of safety of medication
- Multiple temperature monitoring options (loggers, fridges etc.) and lack of integration between them causes delays and data errors
- The temperature logging often ends upon shipment arrival, leaving gaps in monitoring (this is often due to the logger being associated to a complete shipment not an individual pack/kit)
- Shipments/packs can be quarantined for a long time due to uncertainty around safety and the length of time to investigate the temperature excursion(s)
- It is only upon arrival at site that excursions are discovered, increasing the risk that a patient attends a visit and cannot receive medication due to quarantine
