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
Applying Mobile and Cloud Technologies to Temperature Management and RTSM Integration
Technologies such as smartphones and apps, more sophisticated and miniaturized temperature sensors that can use Bluetooth or GPRS to transmit temperature data to mobile devices or the cloud are enabling advances in temperature monitoring and automated temperature excursion management when combined with the RTSM system.
Such capabilities simplify medication management tasks for sites by automating the transfer of temperature data into the RTSM system and automatically determining release / quarantine status. In the case of the need to quarantine medication due to the detection of a single or cumulative temperature excursion, the RTSM system can automatically trigger a replacement supply order.There are also significant benefits for the trial sponsor and patients:
- Cost & risk reduction – wastage and trial delays can be avoided by detecting and managing temperature excursions earlier
- Patient safety is better protected by the improved ability to ensure they don’t receive temperature compromised drugs
- Regulations for temperature traceability can be better adhered to, particularly the need to produce a complete end-to-end audit trail of temperature history
Ultimately, such solutions help reduce the risk and cost of the clinical trial supply chain, create an end-to-end audit trail for better compliance, and increase the safety of your clinical trials.
To learn more, meet me at IRT 2017: CBI’s Interactive Response Technologies in Clinical Trials conference in Philadelphia, October 26-27, and attend my presentation ‘You’re Hot then You’re Cold – Temperature Management and RTSM Integration’ on day 2 at 9:25am.
1 “Global Trends in Clinical Trial Logistics: 2020 Perspective.” 2015. Corex. Accessed at
http://tiny.cc/amlu5x on November 9, 2015.
About the Author:
Associate Product Manager, Patient Technology Solutions
Colette currently works in the Product Management group for PAREXEL focusing on the ClinPhone® RTSM product. In this role, she uses market research and industry analysis to understand the end user’s goals and needs and then defines solutions to meet them. Colette has an extensive education in Mathematics from The University of Oxford specializing in its medical applications. She also achieved a Distinction in MSC Mathematical Medicine and Biology at Nottingham University in 2015 and has completed the PAREXEL Academy Postgraduate Certificate in Clinical Trial Management.