When is it time to switch to a biopharma-specialized courier?

5 questions to ask yourself to choose the right partner

With so many courier services to choose from, a drug developer might struggle to decide which is the best for its clinical trials. This is exacerbated by the fact that, while many courier services may offer biopharma capabilities, they do not have specialized clinical trial expertise. How, then, can developers be sure that their logistical partner will fulfill their needs?

Drug developers evaluating courier partners should look for several specific practices and standards in their courier partners to ensure the rigorous product quality and patient privacy required for clinical trials. Here, we explore some of the most important questions to ask when considering a potential courier company.

Can the courier guarantee GMP-level storage and shipping conditions?

Clinical trial products, particularly investigational therapies, often have different environmental requirements than standard goods. Any courier involved in clinical development should be equipped to maintain and monitor those conditions, not only in transit, but also in storage while waiting for shipment. Such a courier should utilize Good Manufacturing Practice-compliant facilities with backup generators to safeguard stored drugs, and employ real-time monitoring for critical factors such as light, humidity, and temperature.

Does the courier provide temperature-control infrastructure built for clinical trials?

There are a wide range of clinical trial materials that are temperature sensitive, including biologics, cell and gene therapies, and some vaccines. The required infrastructure to protect shipments of these items can be extensive, ranging from specialized equipment and packaging, such as liquid nitrogen dewars and dry shippers, to temperature monitoring technology, such as data loggers.  For temperature-sensitive clinical materials, a courier must not only use validated equipment that prevents excursions, but also maintain consistent, network-wide availability of that equipment so shipments are never delayed due to shortages or long lead times.

Can the courier handle complex direct-to-patient and direct-from-patient coordination?

For many decentralized clinical trials, handoff of time- or temperature-sensitive materials — whether drop off of a drug or pickup of patient samples for analysis — requires strong communication with home health professionals or patients themselves. Timing must be properly aligned to reduce the risk of missed connections or delays, and to protect the viability of the materials. Often, this requires a local representative who can coordinate with patients or their home care teams to meet their individual needs. It also calls for flexibility in the delivery schedule and location, including outside of typical business hours.

Can the courier ensure blinding in decentralized clinical trials?

Most standard couriers don’t have to be concerned about whether recipients know the contents of their shipment. In the case of clinical trials, however, protecting that information can be critical to maintaining a blinded study, as it can reveal whether a patient is receiving a placebo or an investigational product. Couriers involved with clinical trials must have strict, documented processes to protect blinding, such as controlled document handling and patient-neutral packaging.

Is the courier fully aligned with global clinical trial regulations?

Clinical trials must meet a variety of specific requirements for approval, many of which are relevant to the transport of materials, such as maintaining proper conditions or a chain of custody. When couriers do not fully understand regulatory requirements and trial protocols, there is much greater likelihood of missteps or unintentional omissions. Specialized couriers, however, have much deeper experience in meeting biopharma-specific requirements, a better appreciation for the stakes of any breach in protocol, and staff that have been trained in such processes as Good Distribution Practice. Additionally, investigational products often have particular requirements for customs clearance and import to other countries, making it critical for a courier for international trials to be able to anticipate and navigate these requirements in a timely manner. 

Evaluate your trial needs carefully before choosing a partner

Each clinical trial will have its own unique needs and priorities, which drug developers must assess on a case-by-case basis. However, if any answer to the above questions is “no,” it is a strong indication that a more specialized partner, such as Yourway, may be required to help ensure that trial materials are handled with the care and expertise they require.