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Direct-to-Patient (DtP) Clinical Trial Logistics

Key Takeaways

  • Reducing participant burden: Time, distance and the cost of travelling to trial sites can make clinical trial participation more difficult. Bringing selected trial activities closer to participants can help reduce this burden.
  • New guidance for decentralised trials: ICH E6(R3) Annex 2, adopted in June 2026, provides additional Good Clinical Practice considerations for trials incorporating decentralised elements. Thailand also published national guidance on decentralised clinical trials in July 2026.
  • Protecting product integrity: Direct-to-Patient delivery of investigational medicinal products (IMPs) requires clearly defined processes for shipping, storage, handling, accountability, privacy and, where required, temperature control.
  • Scaling across markets: Clinical trial logistics across Asia Pacific must account for country-specific import requirements, regulations and last-mile conditions while maintaining consistent visibility across the supply chain.

What is Direct-to-Patient (DtP)?

Direct-to-Patient, or DtP, is a clinical trial logistics model in which investigational medicinal products, trial materials or other approved items are delivered directly to a trial participant rather than requiring every activity to take place at a traditional clinical site.

  • DtP is one element of a broader Decentralised Clinical Trial (DCT) model. Depending on the study design, decentralised elements may also include remote visits, digital health technologies, home healthcare or sample collection outside the investigator site. ICH E6(R3) Annex 2 specifically recognises trial-related activities conducted at participants' homes, local healthcare centres and other locations outside the investigator site.
  • For Thailand, 2026 marks an important development. On 13 July 2026, the Thai FDA published national guidance on decentralised clinical trials, developed to support the appropriate use of decentralised elements while protecting participant safety, rights and dignity and maintaining reliable trial data.

DHL Group is also investing €2 billion globally through 2030 to expand its life sciences and healthcare logistics capabilities, with 25% of the investment allocated to Asia Pacific. The programme covers infrastructure, technology, temperature-controlled logistics and specialised healthcare supply chain capabilities.

Why is participant retention a major challenge in clinical research?

Recruiting participants is only the first step. Keeping them engaged throughout a study is equally important for timelines, statistical power and the reliability of research outcomes

Participant retention remains a major challenge in clinical research. Dropout rates of around 25–30% are commonly reported, although rates vary considerably between studies. Participants may leave for many reasons, including health, treatment burden, scheduling, personal commitments and logistical challenges such as travel.

  • Travel Distance: Cancer trial patients travel a median of nearly 42 miles for Phase I studies.
  • Rural Hurdles: Participants in remote areas of Thailand often face long and challenging journeys to reach clinical sites in major cities.
  • Human Connection: Specialized couriers act as a professional and reassuring extension of the clinical site right at the participant's doorstep.
  • Supportive Experience: White-glove services go beyond simple delivery to build participant trust and confidence in the trial process.

DtP can help reduce some of this burden when the protocol and local regulations allow.

DHL Health Logistics provides the professional bridge between your laboratory and the participant. We understand that a courier is often the only face of the trial that a patient sees, and we take that responsibility very seriously.

 

What are the 2026 regulatory requirements for DtP?

Regulators are continuously updating their rules to support decentralised models. While the global ICH E6(R3) guidelines mandate a Quality by Design (QbD) approach to safeguard clinical data, local implementation in Thailand relies strictly on national Food and Drug Administration (TFDA) decrees and Good Distribution Practice (GDP) compliance.

  • Global Standards: The updated ICH E6(R3) guidelines coming into effect will be influential for trials conducted in Thailand, emphasising robust quality management.
  • Strict Accountability: The Thai Food and Drug Administration (TFDA) requires comprehensive documentation for clinical trials, including verifiable temperature records for investigational products. This means having a clear audit trail is essential for compliance.
  • Thermal Protection: Advanced shippers maintain 2 to 8°C or -20°C for up to 120 hours, protecting product integrity even during transit disruptions, such as traffic during peak travel seasons like Songkran.
  • Digital Proof: IoT sensors transmit live data to show exactly when a participant received the shipment, providing the evidence needed to satisfy quality assurance teams.

Our investment in digital tools ensures you have a full thermal audit trail. This level of transparency is a requirement for satisfying regulatory expectations in 2026.

 

How do import requirements affect DtP trials across Thailand and APAC?

Importing and distributing investigational products can involve different requirements in each market. For DtP trials operating across Thailand and other APAC countries, sponsors need to consider local regulatory requirements, customs procedures and product-specific conditions before shipments move.

  • Country-Specific Requirements: Import permits, documentation and distribution requirements can vary by market and product.
  • Import Readiness: Complete and accurate shipment information can help reduce avoidable customs and regulatory delays.
  • Local Expertise: Understanding healthcare logistics, customs procedures and local delivery conditions helps build a more resilient clinical trial supply chain.
  • Regional Consistency: Common operating standards and shipment visibility can help sponsors manage trials across multiple markets while adapting execution to local requirements.

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How do you protect investigational products during home delivery?

Moving an IMP outside a controlled clinical site increases the importance of cold-chain integrity, visibility and chain of custody.

For temperature-sensitive products, the required solution depends on the product and route. DHL's Thailand cold-chain guidance notes that passive packaging typically provides around 96–120 hours of hold time, while active systems can maintain temperature with continued power or re-icing.

A DtP logistics solution may include:

  • Temperature control: Qualified packaging selected for the required temperature range and transit duration.
  • Monitoring: Data loggers or smart sensors can provide temperature and shipment visibility.
  • Recipient control: Processes should ensure that IMPs reach the participant or another authorised recipient.
  • Privacy: Blinded shipping and secure handling can protect participant identity and trial information.
  • Exception management: Deviations such as temperature excursions or delivery delays should be visible and managed quickly.

DHL's Direct-to- and From-Patient solutions include temperature-controlled transportation, smart sensors, 24/7 monitoring and blinded shipping options for clinical trial materials.

Can you guarantee a secure chain of custody at the doorstep?

Security, privacy and correct handover are essential when investigational products are delivered to a participant's home. Delivery processes should help ensure that the shipment reaches the verified participant or another authorised recipient while maintaining confidentiality.

  • Identity Verification: We check official identification against trial records before handover, helping ensure that the shipment reaches the correct authorised recipient.
  • Point-of-Use Delivery: Where permitted and required by the study, our couriers can place the medication in the participant's designated storage area or refrigerator according to the delivery instructions.
  • Instruction Support: Where included in the delivery protocol, we can confirm that the participant understands how to handle the packaging and follow the relevant storage instructions.
  • Safe Disposal: We provide a comprehensive service that includes collecting used kits or sharp containers for medical-grade destruction.

What is the role of reverse logistics in home-based trials?

DtP logistics does not always end when a shipment reaches the participant.

Trials may also require biological samples, unused IMPs, devices or packaging to travel back to a laboratory, investigator site or another authorised location.

  • Stability Windows: Biological samples such as blood or urine may need to reach the laboratory within defined time and temperature limits to remain suitable for analysis.
  • Data Integrity: Delays or temperature excursions can affect sample quality and, in turn, the reliability of resulting trial data.
  • Remote Reach: We use specialised transport solutions and our extensive network to reach participants in all regions of Thailand, from the southern provinces to the northern highlands.
  • Unified Visibility: A clinical research associate in Bangkok should see the exact same tracking and temperature data as a sponsor in Europe or the United States.

DHL's clinical trial solutions include direct delivery to participants, collection of samples and management of returns using pre-conditioned packaging where required.

Ready to streamline your clinical trial strategy?

Direct-to-Patient logistics is no longer just a future concept. It’s the best way to improve the patient experience and protect the integrity of your valuable data. DHL Health Logistics is ready to help you scale your research across Thailand and the wider APAC region. 

Check your trial plan and reach your participants with confidence and care! 

Frequently Asked Questions

Direct-to-Patient is a logistics model in which medicines, products or approved trial materials are delivered directly to participants at home or another authorised location. This makes it much easier for patients, especially those in rural areas, to stay in the study while maintaining their daily routines.

These 2026 guidelines require sponsors to use a Quality by Design approach. For trials in Thailand, this means you must have verifiable, digital proof that your investigational products remained stable and secure throughout the entire journey to the patient.

We use real-time IoT sensors inside the shipment that transmit live location and thermal data to a central dashboard. This ensures you and our teams receive an immediate alert if the shipment ever deviates from its required temperature range.

Yes, but it requires a partner with deep expertise in handling the specific local medical licenses and import regulations in each country. Using a standardised digital platform ensures your data and processes remain consistent and comparable across diverse markets like Thailand and the Philippines.

Yes, absolutely. Our couriers perform a strict, verified delivery protocol. This includes checking the participant's official ID to ensure the sensitive medication is handed directly to the correct, authorised person.