As decentralized and flexible clinical trial models mature, they have become an established component of research and development strategies that meet patient expectations for flexibility, ease site burdens and expand access to broader patient populations. While digital enablement remains a key focus, the physical supply chain also plays a critical role and warrants careful consideration during DCT trial planning.

Nowhere is this more evident than at the intersection of central laboratory DCT services and remote clinician delivery models. When these services are planned independently, coordination challenges can arise during study execution. As experience with decentralized models grows, sponsors are recognizing that successful implementation requires planning trial infrastructure. 

From “Rescue Mode” to Intentional Design 

Immediately postCOVID, decentralized capabilities were often deployed reactively to keep trials moving. Remote research clinicians were added mid-study, and home specimen collection was layered on top of site-centric lab workflows. These approaches highlighted the need for stronger coordination—from aligning courier schedules with home visits to ensuring consistent sample handling and clear ownership—while also revealing how earlier planning could reduce reliance on real-time adjustments once visits started.

In 2026, the industry has transitioned from crisis response to intentional trial design. Sponsors recognize that decentralized elements work best when logistics are addressed early in protocol development. This “frontloaded” approach allows trial teams to answer critical questions upfront, such as:

• Which visits can safely occur at home?
• Which specimens can tolerate decentralized collection?
• How will trial supplies, samples, clinicians and couriers be synchronized?

Delayed decisions around logistics, collection methods or courier strategy often surface during visits, disrupting patient schedules or study timelines. Experience shows how coordination gaps emerge when these relationships are not clearly defined, particularly in studies with frequent in-home visits, time-sensitive collections or complex populations. As a result, decentralized models increasingly rely on an integrated operational ecosystem in which clinician scheduling, supply delivery, documentation and quality oversight are aligned. 

Evolving Central Labs in a Patient-Proximate Landscape 

Central labs continue to play a foundational role in clinical research, but their responsibilities have expanded. In DCTs, labs now support sample collection across a broader range of settings, including patient homes and community locations. Early lab engagement in trial design is critical because changes to collection strategies, kits or transport pathways can be difficult once studies begin. For example, kits must now accommodate not only non-clinical environments but also differences regarding in-country acceptance of collection devices, materials and instructions. Ensuring that kits are intuitive, durable and appropriate for local use supports consistency across decentralized settings.

Transport validation becomes more complex when samples move through decentralized courier networks rather than predictable site-to-lab routes. Temperature control is particularly important as specimens and investigational products move beyond traditional environments, requiring tighter coordination between labs, couriers and remote clinicians to ensure requirements are maintained.

To preserve data integrity, central labs are increasingly adopting hybrid operating models. Standardized test menus, harmonized reference ranges and global lab manuals remain centrally managed, while specimen collection moves closer to patients. When logistics are thoughtfully coordinated, this balance supports regulatory rigor while reducing patient burden.

The Remote Research Clinician as a Supply Chain Node 

Remote research clinicians, such as nurses, phlebotomists, registered dieticians and others, are now integral to DCT delivery. Beyond remote patient care, they execute critical activities including specimen collection, investigational product administration and source documentation in the field.

Across decentralized trial scenarios, remote research clinicians serve as a critical execution point within trial workflow. Their visits translate upstream planning into real-world delivery. Many supply chain challenges first surface during visits, when clinician availability, patient readiness and courier timing converge, often testing whether decentralized plans hold up under real-world conditions. This includes coordinating specimen collection, immediate processing where required and documentation while interacting directly with patients. This role becomes especially important in studies with high visit frequency or limited site infrastructure. 

As a result, remote research clinicians are increasingly embedded within the operational flow of DCTs, including in the supply chain. Their scheduled visits must align precisely with the availability of kits, samples and investigational product. 

Field experience shows that even minor misalignment, such as delayed supplies or incomplete kits, can cascade into missed visit windows, increased patient burden and frustration, loss of site confidence and downstream protocol deviations. 

Within operational strategy and responsibility, one lesson emerging clearly is the importance of allowing clinicians to focus on clinical care. When they are asked to improvise logistical tasks like managing investigational product transport or responding to courier disruptions, it can introduce unnecessary risk and distraction. More effective decentralized models place responsibility for logistics with dedicated operational teams, ensuring clinicians arrive fully equipped and able to keep focus on patient safety and data quality. Trial programs that separate these responsibilities have been better positioned to maintain visit consistency and participant engagement. 

Coordination: The New Currency for DCT Stakeholders

Experience suggests that execution quality is driven more by coordination across labs, clinicians and logistics partners than by individual vendor performance. Clear handoffs between these functions help reduce fragmentation and support more reliable execution.

This is especially critical when labs and remote clinician teams share responsibility for supplies and transport. Using the same kits a site would use, applying the same lab manuals and following the same documentation standards helps ensure continuity for patients and investigators. 

From the patient’s perspective, a home visit should feel equivalent to a site visit, not a compromise. 

For sponsors, this underscores the need for clear ownership and escalation pathways. In decentralized models, timely issue resolution requires explicit responsibilities and clear coordination across service providers.

Trial Globalization Raises the Stakes

Scaling decentralized models globally adds complexity. Import and export restrictions, customs delays and regional courier limitations can derail even well-designed trials. For example, in Latin America and parts of the Asia-Pacific, import timelines can stretch for weeks, making just-in-time shipping from a hub in the U.S. or elsewhere impractical.

To mitigate this, DCT programs are increasingly leveraging regional depots and local expertise. Positioning supplies closer to patients reduces transit time and mitigates regulatory bottlenecks, but it is equally important to employ local coordinators who understand cultural nuances, language and regulatory expectations to minimize miscommunication and improve execution.

Standardization remains important, though it increasingly needs to be applied with flexibility across regions. In practice, training for remote clinicians and laboratory personnel is often developed as a global framework and then adapted locally. This helps maintain consistency while aligning with regional requirements.

Putting Patients and Sites First 

At its core, decentralization is about improving the patient experience. Home visits reduce travel burden, expand access and often improve retention, but only when execution is seamless. Missed appointments, delayed kits or inconsistent processes can quickly erode trust. When clinicians arrive prepared and supported, decentralized visits tend to feel familiar and reliable.

Sites must also be protected from added burden. Decentralized models should function as an extension of the site, not an additional administrative layer. When visit scheduling and logistics coordination are handled by centralized operational teams working closely alongside remote research clinicians, site staff can attend to oversight and patient care, and clinicians can focus fully on their clinical responsibilities.

As DCTs Mature 

Industry experience has reinforced that DCT success extends beyond technology adoption. It requires re-designing the supply chain around the realities of patient-centric research. Central labs and remote clinicians sit at the heart of this transformation. When addressed together, they can deliver high-quality data, resilient operations and positive patient experiences, even in the most complex global trials. 

Looking forward, the differentiator will not be whether a trial is decentralized but whether its supply chain is designed for decentralization from the start.

Kelli Aufderheide brings a strategic approach to trial design and execution, working closely with cross-functional teams to ensure that studies are efficient, effective and consistent with the needs of both sponsors and participants. Kelli is a passionate advocate for patient-centric research and is dedicated to advancing the field of decentralized trial solutions through ongoing innovation and collaboration. With more than 19 years with IQVIA Laboratories, Kelli is deeply experienced in process and systems improvement, including project management, project setup, line management and IT.

Michael Marino is an operations and business development leader with more than three decades of global logistics experience, including a long tenure at UPS. As Associate Director for Remote Research Clinicians at IQVIA, he specializes in supply chain strategy, logistics, vendor management and financial stewardship across decentralized and hybrid clinical trial models. Michael works closely with cross-functional teams to optimize operational processes that strengthen quality, reduce patient burden, support scalable remote care delivery and prioritize patient safety.