What is the Direct to Patient model? That is, logistics in clinical trials.
Until recently, participation in clinical trials meant that patients had to make regular visits to the research centre. Today, thanks to the Direct to Patient (DTP) model, this process looks completely different. In this article, you will read about what DTP is and how logistics affects the availability of clinical trials and medicines.
What is the Direct to Patient (DTP) model?
In the Direct to Patient model, medicines or research materials are delivered directly from the clinical trial centre to the patient, bypassing intermediate distribution points. This means that you can receive your treatment at home, significantly reducing the need for visits to the clinic. Transport is fully controlled and complies with pharmaceutical regulations.
DTP sets a new standard of care in clinical trials. What are the benefits for patients?
1. It ensures greater continuity of treatment.
2. It reduces the risk of logistical errors.
3. It enables people who are unable to travel to the trial site themselves for health or geographical reasons to participate in the trial.
In other words, thanks to logistics, clinical trials can be accessible everywhere and to everyone.
How does the Direct to Patient process work step by step?
At MediLogix, we carry out each stage of DTP transport in accordance with pharmaceutical transport safety standards. How do we prepare your shipment and how does it get delivered directly to you? Let's explain it step by step.
1. Preparation and qualification of the shipment
We start by qualifying the material. What does that mean?
First, we analyse what we are shipping, i.e. whether it is medicines, vaccines or biologics, for example. Then we select the temperature of the shipment, precisely adjusted to the temperature range required in pharmaceuticals and medicine. These are:
- +15°C to +25°C - standard range for most medicines.
- +2°C to +8°C - refrigerated transport for vaccines and biologics.
At the customer's request, we can also arrange transport in other specialised temperature ranges - always in accordance with applicable regulations and safety rules
Next, we determine the delivery time, transport route and the amount of materials to be transported. In response to all this, at MediLogix we have various methods of transport at our disposal: road and air. And for more complex shipments, we have the option of transporting them in temperature-controlled vehicles (TCV).
2. Selection of specialised packaging
Before the shipment is sent directly to you, we must pack it properly. To this end, we select thermally insulated, certified packaging for your shipment.
Our packaging is tested under extreme temperature conditions. In addition, it is certified for the transport of pharmaceutical materials. We also adapt it to your individual requirements. Why all this? Because the effectiveness of the delivery largely depends on the quality of the packaging.
3. Real-time monitoring
Our shipment can set off on its journey. However, we will not leave it unattended.
We equip every DTP transport with a temperature logger that records the transport conditions with minute-by-minute accuracy. In addition, we include a GPS system that allows you to track the location of your shipment in real time. This gives our operations team full control over every stage of the journey.
What if, for example, the temperature of the shipment suddenly changes? In this case, the system automatically generates an alert, and the coordinator reacts immediately, minimising the risk of product instability.
4. Delivery to the patient
The shipment is delivered directly to you, with confidentiality and security of personal data guaranteed.
Is that all? Not yet.
5. Final report and data archiving
After delivery, a full order completion report is generated. It includes temperature data from the logger, travel time and checkpoints, confirmation of shipment receipt, operational notes (e.g. about opening the package, communication with the patient), and a certificate of compliance with GDP procedures and the test protocol.
We archive all data in our system. Why? Because it allows you to gain insight into how your shipment was transported.
Why does all this matter? The answer is simple. If you receive your shipment too late or at the wrong temperature, the trial may be interrupted. That is why Direct To Patient requires a precise plan. We are aware of the responsibility of this process. We do not just deliver shipments. We help save lives.
Why is Direct to Patient so important for modern pharmacy?
Clinical trials are moving beyond laboratories. The development of remote therapies, personalised medicine and telemedicine means that patients are becoming active participants in the process, rather than just recipients.
The DTP model meets the needs of patients by increasing the availability of therapies, reducing the risk of delays, improving the quality of clinical data and increasing patient comfort. All of this directly affects the effectiveness of research.
Who benefits from Direct to Patient logistics?
The DTP model was not created exclusively for patients. We transport medicines and medical devices in accordance with PHARMA and BIOPHARMA standards for:
- retail pharmacies,
- clinical centres,
- pharmaceutical wholesalers,
- distribution centres,
- hospitals,
- and medical facilities.
As you can see, Direct To Patient is a comprehensive solution that can support the entire healthcare system.
Is the Direct to Patient model the future of clinical trials?
DTP certainly responds to the growing expectations of patients and the requirements of the medical market.
It is a logistics solution that increases the effectiveness of therapy and accelerates the development of innovation in pharmacy.
At MediLogix, we believe that the future of clinical trials lies in patient-oriented models. That is why we invest in technologies, processes and a team that understands that someone's health is behind every shipment.