Never underestimate the importance of mitigating risk for clinical supplies, whether at rest or in motion, It’s especially true when a high percentage of temperature-sensitive, small supply high-value biologics are being transported to reach specific sub-populations in difficult-to-reach geographical areas.
Many factors contribute to the challenges we face:
- Shipper temperature
- Are you using a shipper that a manufacturer has certified will maintain a specific temperature range? e.g. <-15°C (Frozen) 2°C to 8°C (Refrigerated), 15°C to 25°C (Controlled Room Temperature - CRT)
- What is the ‘hold’ time for that shipper, and is it sufficient to protect materials from the time they are picked up at point of origin through delivery to final destination? e.g. 24-hr., 48-hr., 96-hr.
- External climate (political as well as temperature)
- Is the external temperature so cold that you need to avoid water-based coolants at risk they will freeze and risk product integrity? Or is it so hot that you need special protection just to maintain ambient temperatures?
- Are there risks of civil / labor unrest that might require you consider alternate routing?
- Will you need to clear customs and, if so, do you have the required regulatory knowledge to ensure all documentation is completed correctly?
- Are you willing or able to act as Importer of Record?
- Value of the product
- What is the cost associated with loss of product due to a temperature excursion and/or lost shipment?
- What is the patient impact should the shipment be delayed or lost?
- Fragility of the product
- Will you need proactive intervention to ensure the temperature is maintained in the event of an unexpected delay?
- Do you need to monitor humidity, orientation and/or light exposure?
Clinical supply chains are increasingly complex. Challenges along the way can significantly impact the cost and success of a clinical trial. Issues that must be addressed include GDP regulations, courier choice, the number of hand-offs across the supply chain, customs clearance, documentation queries, and chain of custody responsibilities. This list is not exhaustive!
A proactive risk-planning strategy is required to account for the many variables involved in moving high-value sensitive products across geographies, temperature and time zones. At the end of the day there is still one over-arching goal we must satisfy – moving clinical trial materials on time, in full, and at temperature without impact to the patient.