Direct to patient delivery in trials: FAQs explained — part two

Q: How can we book our shipments?

A: As part of our ongoing commitment to continuously improving the service you receive from World Courier, we have numerous methods that can be leveraged to initiate direct to patient delivery. The appropriate method can be discussed during the onboarding of your project. The Customer Portal is one such tool, there have been several enhancements to this platform over the years with DtP in mind. 

The Customer Portal allows us to develop new, value-adding functionality to enhance your online experience with World Courier.

The Portal’s benefits include:

• Compatibility with most devices — access on any internet-connected desktop, mobile device, or tablet.
• Streamlined order entry process — a quick five-step process to place every order. 
• Customizable experience — the option to select from up to 12 types of email notifications and have them delivered to the shipper, consignee, or other contacts.

You can access the Customer Portal here. Further to this we can support bookings by email and phone. 

Also available is our proprietary clinical trial tool called BioSTAR Next Generation (BSNG) which allows the details of the study to be saved and the bookings made by phone which is a model used where local nurses or sites make bookings. Thus, enabling a series of verifications so the booking can be captured correctly.

Ahead of any bookings, we would be looking to work through a statement of work (SOW) to capture all of the study parameters and these would be entered into the relevant system ready for the shipment orders. 

Q: What does World Courier’s digital landscape for DCTs look like?

A: To deliver DCT services and depot-to-patient, World Courier seamlessly integrates with industry-leading Interactive Response Technology (IRT) platforms, enabling efficient clinical trial management.

The benefits of IRT platforms include automation and reducing potential barriers, thereby minimizing manual intervention. Our team is fully prepared with integrations, necessary paperwork, and non-disclosure agreements (NDAs) already in place to ensure a smooth and secure process.

Not only is the drug dispensing automated, but logistics management is also streamlined. Collections and deliveries can be automatically initiated ensuring efficient and timely investigation medicinal product (IMP) and sample handling.

Q: How does World Courier observe data privacy?

A: World Courier meticulously adheres to national and international data privacy regulations, like the Health Insurance Portability and Accountability Act (HIPAA) in the U.S. and the EU’s General Data Protection Regulation (GDPR). This ensures legal compliance across jurisdictions, providing peace of mind. Beyond that, the data needed to process a shipment requires basic information to execute this, such as collection and delivery addresses. The patient’s name is not required as an agreed form of verification can be indicated in the SOW which could detail patient ID. Where a nurse is involved, we can hold their name, or we can blind details throughout the shipment journey all the way through to proof of delivery (POD) which is most typical. 

The standard operating procedures (SOPs) we have in place give clear guardrails for the staff that will be interacting with the sites and patients, healthcare professionals, and care givers. 

World Courier’s team of experts is well-versed in local patient privacy requirements worldwide. It leverages this knowledge to uphold privacy standards consistently within DCT services, ensuring compliance and protecting patient information. 

Q: How does World Courier manage patient data?

World Courier does not hold or manage sensitive patient data. We only access basic information necessary to successfully execute the shipment, such as address details. The information we do hold we manage carefully in the following ways:

• Adhering to global SOPs that include defined measures for securely handling confidential patient information throughout the logistics process.
• Dedicated resources with specialized training for customer service, operations, and transport to handle patient data with the utmost care to help prevent unauthorized access or breaches.

Local expertise:

• Throughout the network, World Courier has a local representative for our personalized supply chain service, and they support DCT and cell and gene therapy (CGT) inquiries. These experts are part of the team helping effectively navigate country-specific requirements. 

Over and above this we have compliance team ensuring that patient data management is compliant at every stage of a DCT supply chain along with our quality and PSC leads. 

Q: How is temperature control maintained?

A: DCTs can offer greater temperature control than standard approaches. In traditional methods, patients may collect their IMP from the pharmacy and then potentially carry it around before going home to store. Essentially once this is handed over at the site the temperature control element has ceased.

By directly delivering the IMP to the patients’ homes, temperature control is extended from the site in our qualified packaging. The deliveries can be coordinated to coincide with a nurse being present or just to ensure we are arriving when the patient is home and in line with dosing schedule requirements. Where a nurse is not present, the patient can transfer them to the appropriate home-storage setting. This minimizes exposure to unregulated temperatures and ensures the drug’s integrity and effectiveness.

The same principle applies to samples in a DfP model. Samples are taken directly from the patients’ residence, with either a nurse supporting this or the patient providing their sample in the pots or kits provided to them. These are placed into the packaging provided by World Courier which can be temperature controlled or uncontrolled depending on the type of sample or returns.  

Related content: Eliminating the variables in decentralized clinical trials

Q: Why partner with World Courier for DCTs?

A: To ensure a successful DCT model, there are several areas of complexity that must be addressed. Partnering with an experienced logistics provider capable of fully integrating with your team who can facilitate successful planning and delivery of depot, site, or central dispensing solutions. 

World Courier, with its global reach, is equipped to meet any clinical trial sponsor’s DCT  requirements. Our agility allows us to respond promptly to any necessary changes. Additionally, our extensive experience in providing DCT logistics and storage solutions for DCTs worldwide enables us to support clinical trial sponsors in delivering successful decentralized trials.

Contact us to find out how we can assist you in meeting your DCT needs.