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.
To monitor temperatures during shipping, nearly all temperature-sensitive shipments include a validated temperature logger. Such loggers are activated manually at point A, deactivated, read and reactivated at point B, and so on from location to location until they reach the investigational site. Data or PDF downloads collected from those loggers are often entered manually into a spreadsheet or database and then they are sent via e-mail to the sponsor to facilitate manual drug release procedures to the investigational site.
Typically, data are not collected or reported in real time. Therefore, products can be out of their temperature window for a considerable time before it’s detected. Resupplying material can be costly and cause delays in getting drug to sites and patients. It’s also difficult to get an aggregated view of temperature data throughout the entire ‘supply chain of custody’ – from the manufacturer to the patient.
It is also becoming essential to know where all of your Investigational Medicinal Products (IMP) are at all times, but particularly for high-value or controlled substances. The World Health Organization (WHO) - Annex 9 - Model guidance for the storage and transport of time and temperature-sensitive pharmaceutical products (TTSPPs) states: “Ensure that stock and distribution records enable traceability or stock tracing of TTSPPs from the point of supply to the end-user or patient. Traceability should include records of temperature exposure of the product during internal shipping and storage.”
Proactive supply chain management using near real-time data
You can detect and respond to delays, temperature excursions, damage and other environmental obstacles throughout the chain of custody With temperature and location devices, both mobile and in storage units, that transmit data regularly to a central cloud data server, . This capability also provides the possibility to aggregate IMP temperature data across that entire chain to enable calculation of mean kinetic temperature (MKT). This enables a more informed proactive approach to managing the clinical trial supply chain with the benefits of:
- Traceability – the location of your IMP is known at all times
- Cost & risk reduction – wastage and trial delays can be avoided by detecting temperature excursions early; deviations from shipment routes or unexpected removal of drug from facilities can be detected
- Patient safety is better protected by increased ability to ensure they don’t receive compromised drugs or get impacted by shipment delays
- Regulations for temperature monitoring and traceability can be better adhered to, particularly the need to produce a complete end-to-end audit trail of location and condition of drugs
Ultimately, such a solution helps reduce the risk and cost of the clinical trial supply chain, create an end-to-end audit trail for better compliance, and increase the security and safety of your products. Helping your products and you to keep your cool. To read more about the temperature management and traceability challenges of the clinical trial supply chain and how mobile and cloud technologies can be applied to help, download the white paper ‘Applying the Internet Of Things to the Clinical Trial Supply Cold Chain’
1 “Global Trends in Clinical Trial Logistics: 2020 Perspective.” 2015. Corex. Accessed at http://tiny.cc/amlu5x on November 9, 2015.
Sanjay Vyas, Corporate Vice President, Global Head of Clinical Trial Supplies & Logistics
Sanjay Vyas leads PAREXEL’s Clinical Trial Supplies & Logistics organization.
Sanjay brings more than 20 years of global experience and expertise across various service industries. Most recently, he worked at DHL in Singapore as Vice President, Asia Pacific, Life Sciences & Healthcare. There, he managed and led the company’s regional logistics and supply chain business and supported large healthcare industry clients.