The success of a clinical study depends on the CRO’s or sponsor’s ability to bring together people, processes and technology in a coordinated effort to improve patient outcomes, one case at a time.
Logistics partners play a similar central role in the process by transporting medications and bio-materials between laboratories, apheresis centers, manufacturers and clinical sites around the world. The logistics partner’s role is critical to the success of the study as a whole, and never more important than in studies of personalized medicines, such as cell and gene therapies.
As logistics providers, of course, we can’t control the effectiveness of therapies, but we can give them the best possible chance of success. Our job is to make sure those samples and therapies arrive where they are needed, when they’re needed and in the same condition they left the lab or collection site.
Key indicators of successful logistics performance
Measuring logistics performance is important to everyone involved. For the logistics provider, measurement helps identify areas for improvement and refine future performance. For the trial sponsor or CRO, measurement hones in on specific reasons for trial delays or other unwanted results. It also helps in deciding whether you want to partner with that logistics provider again.
Logistics performance can affect the outcome of every aspect of clinical trials, from lab to therapy delivery to study costs and regulatory approvals. Six key indicators of successful logistics performance include:
- Minimizing temperature excursions
- Maintaining quality standards
- Optimizing production
- Ensuring on-time delivery of product
- Minimizing overages and shortages
- Maintaining regulatory compliance
Key questions to ask your logistics partner
When the shipment is an ultrasensitive cell or gene therapy, or the bio-materials used to manufacture personalized medicines, then the stakes can be much higher than with everyday deliveries. There is no room for error. Late arrival, temperature variation, sometimes even package tilt can damage the samples and ultimately risk the health of the patient and the outcome of the trial.
Five questions essential in your cell and gene therapy logistics journey are:
- What is their experience with customs in the countries your shipments will leave and arrive?
- What is their experience in specific countries, with different airlines,and how will they deal with unforeseen challenges?
- How do they create and enforce standard operating practices globally?
- How do they assure your bio-materials reach their foreign destination on time and in perfect condition?
- What kind of global logistics team do they have on the ground with experience handling gene and cell therapies or bio-materials?
Shipments must be handled with the same skill, knowledge and urgency, regardless of their destination. To assure that they are, your logistics partner has to work with local operatives, speaking the local language, trained to the same standards in every study site location. Your team abroad must understand that there are patients waiting for your medicines – in some cases, those therapies could save a life.