DEMYSTIFYING THE CLINICAL TRIAL SUPPLY CHAIN

Clinical trials are essential for validating the safety and efficacy of new pharmaceutical products before they are approved for release. However, clinical research is just one component of the complex supply chain required to deliver life changing therapeutic treatments to patients.

Key components of the clinical trial supply chain

The clinical trial supply chain encompassing a range of processes to ensure investigational and registered clinical trial supply products like comparators, concomitants and standard of care medications reach clinical trial sites and patients efficiently and securely.

This complex network ranges from manufacturers to sourcing specialists and logistics providers, each playing a vital role in maintaining the integrity and efficiency of the supply chain.

Explore the clinical trial supply chain in more detail below.

1. Clinical trial supplies (CTS)

Clinical trial supplies (CTS) include registered pharmaceuticals including comparator, concomitant and standard of care medicines, which are all critical for the successful execution of a clinical trial.

These supplies are sourced from validated suppliers or directly from manufacturers who ensure the quality and compliance of the products.

2. Manufacturing / Primary manufacturing

Primary manufacturing involves the production of investigational and clinical trial supply products, placebos, packaging and the assembly of patient-visit kits. Pharmaceutical companies or specialised contract development and manufacturing organisations (CDMOs) are typically responsible for this stage. They ensure that the products manufactured meet the required quality standards and regulatory guidelines.

3. Secondary manufacturing

Secondary manufacturing includes the labelling and packing of clinical trial supplies including comparator, concomitant and standard of care medicines. This step is crucial for ensuring all products are correctly identified and meet the specific requirements of the trial. It often involves adding unique identifiers or barcodes to track products throughout the supply chain.

4. Storage

Secure storage is essential to maintain the integrity of clinical trial supplies. Products are stored in temperature-controlled environments to prevent degradation and ensure efficacy. Storage facilities, such as clinical trial depots, must comply with good practice (GxP) guidelines, including good distribution practice (GDP) and/or good manufacturing practice (GMP).

5. Distribution to site or patient

Once relabelled or kitted, the products are either distributed direct to clinical trial sites such as hospitals and research centres that administer the treatment to patients, or directly to patients (DTP) themselves.

Direct to site: Direct to site involves delivering clinical trial supplies, investigational products and other necessary materials, directly to clinical trial sites, such as hospitals, clinics and research centres, where the trial is being conducted. This step requires meticulous planning and coordination to ensure timely delivery. Clinical trial logistics companies often use advanced tracking systems to monitor shipments and prevent delays.

Direct to patient: Direct to patient (DTP) involves shipping clinical trial supplies directly to participants’ homes or other locations outside the clinical trial site. This is typically managed by specialised pharmacies or dedicated home-delivery services and is especially common for decentralised clinical trials. Ensuring patients receive their medications on time is critical for the integrity of the clinical trial and ensuring patient compliance.

Flow chart: Supply chain for clinical trial supply

This diagram illustrates the clinical trial supply chain from product manufacturing and storage to distribution and dispensing to patients.

Conclusion

There are many challenges associated with sourcing clinical trial supplies and managing the clinical trial supply chain, each requiring careful coordination and collaboration among various stakeholders. From manufacturers to sourcing specialists and logistics providers, each link in the chain has a critical role in ensuring that medicines reach clinical trial sites and patients efficiently and securely.

By anticipating key challenges and proactively planning, companies can optimise their supply chains to ensure pharmaceutical products are delivered when and where required to support the success of clinical trials.

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About AKESA

At Akesa, we specialise in sourcing comparator, concomitant and standard of care medicines for use in clinical trials, ensuring smooth and efficient clinical trial operations. Contact us to learn more about how we can support your clinical research needs.

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