Delivering GxP: A holistic approach to clinical logistics

In clinical development, we follow  a set of quality regulations and guidelines — Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Distribution Practice (GDP) — to ensure the ethical conduct and data integrity of clinical studies, the consistency of investigational products, the reproducibility of lab testing, and the quality and integrity of drugs during storage and transport. Known collectively as GxP, these guidelines are closely linked, as a trial’s success depends on the reliability of both its drugs and supporting data. Too often during operationalization, however, aspects of Good Practice are siloed. This fragmentation results in oversights that negatively impact timelines, budgets, and ultimately patients. 

In our experience, there are five major impacts of siloed Good Practice implementation during clinical development: 

1. Unavailability of materials: Phase 1 studies typically begin in a single country, where the GMP-compliant manufacturing process ensures that the investigational product and all ancillary supplies are compatible and appropriately qualified. As trials expand globally, development teams may discover that some necessary components, such as comparator products or medical devices, are unavailable in certain regions or restricted by regulatory requirements. Logistics teams that support global expansion can anticipate these challenges and help direct manufacturing and sourcing decisions accordingly. Making informed choices early streamlines the entire development process. 

2. Lack of planning for lab assay requirements: Often, a single assay can’t meet regulatory requirements in multiple regions. For example, an FDA-approved lab assay may not comply with the EU’s In Vitro Diagnostic Regulation (IVDR), which demands stricter validation and evidence. Neglecting to address these differences can stall recruitment, force revalidation, or invalidate collected data. To minimize risks, teams should involve regulatory experts to secure approvals or identify compliant alternatives while also building contingency plans with backup assays.  

3. Misunderstandings about timelines: Global supply planning often defaults to the longest possible approval time. For example, if a country can take up to 90 days for regulatory approval, a non-integrated drug provider may not supply product earlier than that, leading to disruption if approval is accelerated. Integrated logistics teams address this by partnering closely with regulatory colleagues to model a full range of timeline scenarios, mitigating the risk of stockouts and enrollment delays. 

4. Delivery complications: In early-phase studies, researchers are still determining a drug’s stability profile. By phase 3, more robust stability data inform logistics planning. This is particularly critical for cell and gene therapies (CGTs), which often have very short shelf lives and require ultra-cold chain management. Logistics planning must account for the time required for therapies to clear customs, undergo batch release (including a Qualified Person to release in the EU where required), and be administered to patients. CGTs must also have a highly controlled and fully documented chain of custody.  

5. Lack of awareness of region-specific legislation: A global study must comply with varied and sometimes restrictive local laws. For instance, the Texas Genomic Act of 2025 prohibits certain organizations in the state from using genome sequencers or related software from specific countries, including China and Russia — a law that significantly impacts life-sciences research. In another example, China regulates the collection of genetic material by foreign entities as well as the the export of human genetic samples and related data. Without early awareness of such legislation, sponsors risk costly protocol amendments and site activation delays and may be forced to exclude key markets. Integrated planning ensures that compliance requirements are addressed during study design, not discovered mid-trial. 

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Breaking down silos: An integrated approach   

Delivering integrated GxP, rather than siloed Good Practice, requires a fundamental shift from fragmented, sequential planning to organization-wide collaboration beginning at study inception. Industry leaders accomplish this through: 

Early, cross-functional planning: Clinical logistics cannot be an afterthought. Integrating supply chain expertise into protocol development enables teams to proactively address location-specific regulatory requirements, manufacturing constraints, import/export complexities, and supply chain risks. At Parexel, our track record demonstrates that this front-loaded approach, inclusive of project planning, prevents costly protocol amendments, site activation delays, and supply shortages that arise when logistics considerations are retrofitted into trial designs.   

In a recent oncology study, for example, Parexel ensured successful transport of time-sensitive peripheral blood mononuclear cell (PBMC) samples. With advance notice and coordinated workflows,  logistics specialists secured same‑day priority transport  to meet accelerated timelines. Through cross‑functional collaboration, all samples were packaged, shipped, and received by the central lab within the 24‑hour window required by the protocol, preserving sample viability and preventing loss of critical study material. 

Minimizing supply chain handoffs and prioritizing continuity: Unified oversight across all supply chain functions — investigational product supply, ancillary materials, laboratory logistics, and global trade compliance — eliminates the delays inherent in multi-vendor handoffs. In a recent study with sites in Europe, for example, the sponsor believed the CMO responsible for the investigational product would also provide a controlled substance that was the standard of care. When the CMO declined, Parexel's European experts stepped in to handle licensing requirements and local sourcing.  
 
Gaps like this are not uncommon because early- and later-phase planning are handled by different teams. Decisions about drug manufacture are made in phase 1 or 2, and these choices impact country selection and many other aspects of planning in phase 3. In this example, the sponsor needed an end-to-end supply chain manager to anticipate the limitations of central sourcing in specific regions. That’s why the Parexel Clinical Logistics model uses a single point of contact with a holistic view of the development program. The expert in this role ensures seamless coordination, faster issue resolution, and consistent quality across the entire supply chain.  

The complexity of global clinical trials — particularly for advanced therapies and decentralized models — demands supply chain strategies as sophisticated as the science they support. When logistics professionals collaborate with regulatory and clinical experts to address GCP, GMP, GLP, and GDP from study inception, organizations can increase productivity, reduce risk, and deliver drugs to patients more reliably.  

Parexel Clinical Logistics combines deep clinical trial expertise with global supply chain capabilities to deliver integrated solutions across all phases of development. To explore how our approach can accelerate your programs and reduce supply chain risk, please get in touch.   

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