PPD™ Clinical Research Business of Thermo Fisher Scientific
linical trials drive medical innovation and transform patient care—but success often hinges on more than science alone. The movement of drugs, supplies, data, and even people across borders is a puzzle that can determine whether a trial stays on track or stalls. The import, export, and local transit of clinical supplies and study medications are some of the most complex pieces of that puzzle.
Drawing on experiences from clinical project leads and global clinical supply managers, this article explores real-world challenges and the strategies used to overcome them. Insights from Argentina, Turkey, and elsewhere can guide sponsors, clinical research groups, and sites toward more efficient, resilient, and compliant clinical supply management.
Managing Clinical Supplies Across Diverse Regulatory Landscapes
The provision of clinical supplies in Argentina and Turkey, as representative examples, present a complex mix of regulatory, logistical, and operational challenges. Each country brings its own structure and interpretation to clinical trial oversight—from Ethics Committee-dependent review processes to the geographic and infrastructural realities that influence delivery. These variables can significantly affect timelines, sometimes delaying the arrival of critical supplies and, ultimately, impacting patient care and study continuity. These challenges become even more pronounced in decentralized trial models, where shipments are made directly to patients’ homes. To manage this complexity, clinical research teams rely on robust supply strategies built on global and local partnerships, transparent processes, and effective communication.
Argentina: The Regulatory Impact on Clinical Supplies from Import License to Last Mile
In Argentina, clinical trial oversight is governed by the National Administration of Drugs, Foods and Medical Devices (ANMAT), with additional layers of local and provincial engagement that influence operational execution. The import license process is one of the most significant factors shaping study timelines. Each investigational product shipment requires formal review and authorization, supported by detailed documentation submitted to ANMAT and coordinated through local representatives.
This structured oversight reinforces regulatory integrity and traceability; however, it also introduces procedural sensitivity to change. Any modification to shipment contents—including adjustments to quantity, ancillary materials, or product configuration—typically requires submission of a revised import license. Each revision must undergo review and approval before it is released, and even minor updates can extend timelines by several weeks. In practice, this necessitates conservative forecasting and disciplined change control during study start up and throughout enrollment.
Operational experience further demonstrates that sourcing strategy and regulatory eligibility are closely intertwined. In one program, globally approved vendors were unable to supply a sterile water product that met Argentina’s specific authorization requirements. Conversely, certain local suppliers had the product available but lacked the certifications required to distribute under clinical trial import conditions. To resolve this situation, the study team expanded its regional vendor assessment to identify and include a supplier with both the necessary regulatory approvals and distribution credentials. Establishing this alternative supply pathway preserved continuity of treatment and maintained compliance with ANMAT import provisions.
This experience reinforced another operational principle: Vendor qualification must extend beyond sourcing capability to include confirmation of regulatory authorization status and familiarity with Argentina’s import controls. These interdependencies, combined with rigorous documentation standards and multilayer review, illustrate how Argentina’s regulatory framework directly (and positively) influences its clinical supply strategy, shipment cadence, and study continuity.
Turkey: When Clinical Timelines Meet Regulatory Reality
In Turkey, the import license review process for investigational medicinal products generally proceeds more efficiently than in Argentina, reflecting the efficiencies of centralized national oversight. However, the range of products with existing local approvals may be narrower, occasionally constraining sourcing flexibility and requiring earlier strategic feasibility assessments.
Under the current regulatory model, Ethics Committee approval must be secured prior to Ministry authorization, establishing a sequential review pathway that directly shapes study start-up timelines. While this structure reinforces alignment between governing bodies and supports layered oversight, it limits opportunities for parallel submission strategies and requires deliberate coordination of milestones to avoid avoidable delays.
In Turkey, clinical trial oversight is centralized under the Turkish Medicines and Medical Devices Agency (TİTCK) within the Ministry of Health and governed by the Regulation on Clinical Trials and related implementing guidance. The framework delineates responsibilities between Ethics Committees and the Ministry, with nationally codified submission requirements and defined authorization procedures for both study approval and investigational product importation. This centralized model creates a structured review pathway and a clear institutional hierarchy for sponsors navigating the process.
Although the regulatory framework is formally established, certain operational elements—particularly those involving specialized supply scenarios or nonroutine import circumstances—require practical engagement with the authority. Written provisions are sometimes articulated as principles rather than prescriptive instruction. In practice, this can introduce variability in how documentation or procedural details are interpreted and assessed.
Language considerations remain operationally significant. Turkish-language documentation is required, and even minor variations in translation—particularly for technical or specialized procedural descriptions—can influence interpretation. Engaging local regulatory specialists familiar with both Ethics Committee and TİTCK expectations has consistently reduced clarification cycles and supported smoother progression through the formal review pathway.
Collaborative Solutions and Regional Insight
These experiences in Argentina and Turkey show that success depends on early planning, solid regulatory awareness, and open communication among all involved parties. Local specialists are essential for interpreting national requirements, ensuring accurate documentation, and managing approvals efficiently.
Collaboration with qualified vendors and couriers continues to be one of the most consequential actions for reducing complexity. Local partners often possess firsthand knowledge of regional approval requirements, import expectations, and sourcing networks. In Argentina, for instance, entrusting licensed couriers with end-to-end logistics has helped streamline the process and maintain compliance.
Finally, consistent communication among sponsors, depots, vendors, and regulators prevents gaps that can lead to delays or misinterpretations. A predictable, transparent information flow fosters accountability and trust and enables teams to anticipate issues before they escalate. Together, these coordinated efforts support the seamless and compliant flow of clinical supplies across both nations.
Direct-to-Patient: Redefining Investigational Product Delivery in the US
Patient-centric and decentralized clinical trials are rapidly reshaping the way studies are conducted in the US. With more investigational products (IPs) being administered in patients’ homes rather than at clinical sites, supply chains are extending beyond traditional boundaries. Shipping IPs directly to patients introduces a new layer of complexity that merges logistics, regulation, and cost management into a single, finely balanced process. While the approach offers convenience and improves patient engagement, regulations and standardized practices around home administration are still evolving, leaving sponsors and supply teams to interpret and implement best practices in real time.
Logistical Realities
Unlike traditional site-based supply models, direct-to-patient shipments require a finely tuned process that extends beyond the clinic. IPs, often in powder form, must be reconstituted with sterile water and accompanied by a range of ancillary materials such as syringes, cool packs, instructions, and more. Coordinating these elements so that everything arrives intact and on time can feel like a logistical jigsaw puzzle, especially when patients live hundreds of miles from the nearest clinical site.
Regulatory Nuances
Regulatory expectations add another layer of precision and complexity beyond logistics. Each US state can interpret shipping and storage requirements—what patients may transport, how materials must be stored, and when temperature controls are required—differently. Typically, patients can take home ancillary supplies like syringes, needles, and sterile water during site visits, but the IP itself must often be delivered separately by a licensed courier. This split process protects product integrity but requires tight coordination between sites, depots, and couriers to stay compliant and on schedule.
The Cost Equation
Every mile matters, not just in distance but in dollars. Direct-to-patient shipments can be costly, sometimes reaching several thousand dollars per courier trip. For smaller sponsors, these costs can quickly become a deciding factor in trial feasibility. Balancing patient convenience with budget constraints has become one of the most delicate aspects of modern clinical supply management.
What Works in Practice?
Experience has shown that three factors make the biggest difference: partnerships, planning, and precision. In US-based studies, specialized clinical couriers with established handling procedures have prevented temperature excursions from escalating into protocol deviations. In one multicenter trial, validated packaging configurations were aligned with seasonal risk forecasts in advance. When severe weather disrupted routing, predefined escalation pathways allowed the shipment to be redirected without compromising product integrity or delaying dosing.
Transparent communication among sponsors, vendors, depots, and sites has proven equally essential. Consistent cross-functional meetings—including routine supply governance calls and milestone-based stakeholder reviews—have reduced misalignment and strengthened operational clarity. In a decentralized study utilizing direct-to-patient delivery, standing weekly touchpoints between the sponsor, IRT vendor, depot, and clinical sites allowed teams to review enrollment trends and confirm shipment timing before release. These structured checkpoints reduced failed deliveries, avoided duplicate shipments, and preserved supply continuity.
In one adaptive design program, strategically positioned buffer inventory across US depots enabled rapid redistribution when enrollment exceeded projections. Because contingency pathways were defined early and reviewed regularly, supply continuity was maintained without emergency resupply measures.
Technology has reinforced these controls. Real-time shipment tracking and integrated temperature monitoring now provide continuous visibility across the delivery chain. Automated excursion alerts enable quality teams to assess and disposition product before site receipt, reducing quarantine events and avoiding unnecessary replacement shipments. In direct-to-patient models, integrated tracking and environmental logs have strengthened chain-of-custody documentation and improved audit readiness.
Clinical Supply Challenges Across Africa and the Middle East
Ensuring a reliable clinical supply chain is essential to the success of any study, and nowhere is this more evident than in regions such as Africa and the Middle East. These markets represent an expanding frontier for clinical research, but their diversity, regulatory variability, and infrastructure differences can make supply operations uniquely complex. Recent interviews with industry experts illustrate several themes running through both the challenges and the progress in managing supplies across these regions.
Regulatory Variation
One of the most persistent hurdles is the diversity of import regulations across countries. In certain countries, such as Oman, the clinical site must act as the importer of record, which adds administrative layers and can limit flexibility, especially when they use third-party couriers. For example, a central lab may face difficulties if its courier lacks operations in the destination country. These challenges are compounded by the fact that local regulatory frameworks often differ significantly from those in other regions (such as the EU), requiring additional oversight and documentation.
Political and Infrastructure Realities
In some African countries, such as Kenya and Tanzania, political instability and uneven healthcare infrastructure can further complicate supply operations. Political unrest in Kenya in 2025, including protests, which resulted in multiple fatalities, impacted site operations and travel safety, and posed other, difficult to predict, risks. Such conditions can make it difficult to identify vendors with the required experience, certifications, or capacity to meet Good Manufacturing Practice standards. Selecting reliable local partners is therefore a critical factor in maintaining quality and compliance, as well as in ensuring continuity when global suppliers face constraints.
Logistical Pressures
Logistics remain a defining challenge. Something as simple as sourcing adequate volumes of saline containers can create ripple effects throughout the supply chain. Long lead times, short expiration windows, and country-specific labeling requirements often intersect, creating pressure points that demand precise coordination and flexibility. In some cases, relabeling supplies to meet local regulations adds both time and cost, underscoring the importance of anticipating these variables early in the planning process.
Operational Approaches
A study team in Nigeria experienced a commercial supply shortage of saline for infusion in 50ml containers and identified an alternate supplier in Germany. However, the German label on the saline was not acceptable for the Nigerian customs. As a result, the study team had to organize translating and relabeling this German product with English labels, as well as translating the Summary of Product Characteristics (SmPC) from German to English, to meet import requirements.
In another example, a study team received lab supplies from a vendor with only four-month expiration periods—an importation challenge in countries such as Saudi Arabia which requires:
- Issuing the correct commercial invoice for each exact kit, which had to be identified on each invoice; this delayed preparing the invoice until the kit was complete and its expiration clock was already ticking.
- Obtaining the import license before shipment could proceed.
Document preparation, importation, and delivery to the site effectively reduced the supplies’ shelf life to four months. Mitigating the risk of lab kits expiring within four months required thorough training of site staff in overseeing remaining stock at site and reviewing expiry dates.
Infrequent patient visits (at six- or 12-week intervals) required constant oversight of current supplies and planning for the next resupply. Site monitors were required to review the remaining lab supplies and expiration dates in their monthly site management calls to ensure an additional layer of oversight.
Collectively, these experiences highlight that while the clinical supply landscape in Africa and the Middle East is complex, it is also navigable. Success depends on understanding the variability between markets, anticipating procedural differences, and cultivating strong regional partnerships that keep studies running smoothly in dynamic environments.
There will be challenges. For example, resupply of consumable items may require significant time where importation processes are complex; import licenses may be required for each specific shipment (including exact identification of shipped items and the amounts shipped) and may have expiration dates.
Conclusion
The movement of clinical supplies across borders remains one of the most complex and defining aspects of clinical research studies. Each region introduces its own blend of regulatory rigor, logistical realities, and cultural context—factors that shape how studies are executed and how quickly patients can access investigational products.
Experiences from Argentina, Turkey, Africa, the Middle East, and the US demonstrate that while the specific challenges differ, the underlying principles remain consistent: Clarity in documentation, early coordination, and effective communication among global and local teams are essential to success. These shared lessons underscore that clinical supply management is as much about collaboration and adaptability as it is about compliance.
The content of this article does not necessarily reflect the views or policies of Thermo Fisher Scientific (TFS). Examples shared in the article represent authors’ collective experience.