In clinical trial supply, the journey from pharmaceutical product inception to clinical trials is multifaceted.

From product access, supply continuity and cost management to lead time efficiency, supply chain quality, and the importance of documentation, each factor plays a pivotal role in ensuring that clinical trials proceed seamlessly, adhering to budgetary constraints, and maintaining the highest standards of quality and compliance.

Below, explore the steps involved in the clinical trial supply chain and the key considerations to a successful clinical trial.

Product access

One of the primary considerations in clinical trial supply is ensuring reliable product access. This involves assessing the ability to supply the required pharmaceutical product, understanding the channels through which the product is obtained, and evaluating the number of organisations it may pass through before reaching the patient.

Supply continuity

Supply continuity is a critical factor in clinical trials, especially considering that most trials span several years. Ensuring the consistent supply of registered pharmaceutical products throughout the trial’s lifecycle is essential. This continuity in sourcing from the same company or market ensures greater reliability and uniformity in data collection.

Cost

Cost plays a pivotal role in clinical trial supply sourcing. Managing the price of the product over the trial’s duration is vital to adhere to the sponsor’s budget. Variations between the wholesale list price and clinical trial price can vary across territories. Therefore, securing a stable price over the trial’s lifecycle is crucial. While some international markets experience stable or declining product prices over time, the United States typically experiences price increases. Navigating these pricing complexities helps to support cost-effective clinical trials.

Lead time

Timeliness is of utmost importance in clinical trials. Delays in trial initiation can be costly, and the speed at which clinical trial supply (CTS) products can be sourced significantly impacts trial timelines. Managing lead times throughout the trial’s lifecycle is essential for resupplies and to prevent bottlenecks.

Quality of supply chain

Maintaining the highest quality standards throughout the supply chain is critical. Products must adhere to good distribution practices (GDP) requirements to mitigate risks associated with deviations from MAH-listed specifications for storage or transportation, and to prevent supply chain damage. Upholding these quality standards ensures that lead times are met, and delays are avoided, ultimately supporting the success of the clinical trial.

Documentation

Access to a comprehensive suite of documentation is vital in the business of clinical trial supply. These documents serve multiple purposes, including ensuring the integrity of sourced products and meeting regulatory requirements for clinical trial submissions. They may also be necessary for importation into specific countries as part of the customs clearance process. Key documents include, but aren’t limited to,:

• Certificate of Analysis (CoA),
• Certificate of Conformity (CoC),
• GMP certificate from the MAH’s manufacturing plant,
• Regulatory documents including chemistry, manufacturing, and controls (CMC) details, dossier information, and bioequivalence letters.
• Pedigree certificate.

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Partner with Akesa

Akesa places a strong emphasis on maintaining close working relationships with marketing authorisation holders to ensure efficient lead times and access to documentation, to facilitate a smooth and compliant clinical trial supply process.

Image by Jason Goodman on Unsplash.