Betsy Louda, Associate Editor11.15.17
As the biopharmaceutical industry grows, so does the number of extremely temperature-sensitive medicines used in various clinical trials. This increases the opportunity for error and other issues with workflow, packaging, transporting, and storing of those drugs.
PAREXEL Inc, a global biopharmaceutical services provider, has set out to solve that problem. They have released a new feature for their ClinPhone RTSM Mobile Application that will provide beginning-to-end temperature monitoring of a medication. In addition to the live temperature reporting, the complete history of the product’s temperature from packaging until it is with the patient will be available via a Bluetooth wireless sensor system to view at any time.
In the next few years, it is expected that eight out of the top ten global biopharmaceutical products will require cold chain management, which means ensuring a constant temperature for a sensitive product. Just several degrees can make a huge difference in the safety of a medication, and research has shown that the majority of these kinds of mistakes that impact medications, occur during storage at the clinical site. Associate Product Manager at PAREXEL, Colette Thorold gave us some additional insight on the importance of their new cold chain management feature.
CP: What are the biggest challenges associated with transporting temperature-sensitive clinical trial materials?
Colette Thorold: An increase in the number of temperature-sensitive clinical trial materials creates an extra burden for site users, as they must process the arrival of shipments and ensure the data from the temperature loggers is received by the Clinical Research Associate (CRA) and/or the Interactive Response Technology (IRT) system. This is time consuming and can result in delays in the medication’s availability at sites after it has arrived.
An additional major challenge is fragmented design of current temperature monitoring processes. Traditionally, one logger is used to monitor the medication during shipment, and then the site will rely on manual checks of fridge/storage temperatures. This inevitably results in large gaps in the temperature data, as the packs move around the site without any formal temperature monitoring. It has been demonstrated that the majority of temperature excursions occur on site, so it is vital sponsors address the need for a better monitoring system, especially during this period.
CP: How can they be overcome?
Colette Thorold: Challenges can be overcome by creating a process in which the site user can wirelessly and automatically ensure the data from the loggers is received in the IRT system. This will reduce the time taken to process shipments, as well as remove any room for human error in manual data transfer. In addition, the sites will have the option to check the status of the loggers at any point during arrival and storage at site.
Through in-pack temperature loggers, sponsors have the assurance of end-to-end traceability of the temperature profile of the medication. The full temperature profile of that medication flags to sponsors any points between packaging and dispensation where the pack may have been temperature-compromised.
CP: How do technology solutions play into the various stages of drug development?
Colette Thorold: For temperature-sensitive materials, technology solutions can help at all stages, but the benefits are likely to be greater once sponsors have a larger volume of medication packs and shipments in later stage studies.
CP: How has cold chain management changed over the past few years?
Colette Thorold: There have been significant advances over the last few years in terms of packaging with Vacuum Insulating Panels (VIP) and Phase Change Materials (PCM) providing more flexible and robust protection during distribution. Sophistication and miniaturization of temperature monitoring devices have created the ability to store data for longer periods and wirelessly transmit that data either on-demand via Bluetooth to another device (gateway data collector or smart phone), or via the cellular network in near real-time to the Cloud.
CP: What are some of the services pharma/biopharma clients look for with respect to cold chain management?
Colette Thorold: Our clients are looking for complete service comprised of packing in a controlled environment, worldwide distribution in temperature-controlled packaging (VIP / PCM), continuous temperature logging, proactive management in the event of temperature excursions (i.e. intervene to restore to correct temperature, or reorder replacement product) and automated audit trail of temperature history for regulatory compliance.
Learn more about PAREXEL's mobile app here
Learn more about PAREXEL's mobile app here