Three reasons for effective clinical trial distribution strategies

Distribution is a crucial part of the clinical trial supply chain

Following the globalisation of clinical trials, ensuring investigational medicinal products (IMPs) requires overcoming challenges including import, export, regulatory requirements, and transport logistics.

Establishing an effective clinical trial distribution strategy ensures the right IMPs reach the trial site, distribution agency or patient at the right time while maintaining product quality.

Partnering with an experienced distribution partner is the most effective solution. As distribution experts, we use our experience to forecast the supply chain and minimise risks that may arise during the process. This ensures we overcome challenges, stick to budget and timeframes.

Here are three key reasons why an effective clinical trial distribution strategy is crucial

1. Maintain compliance with regulatory requirements

Regulations can differ from country to country. When clinical trials are conducted in multiple countries and regions, it is vital to be aware of the different regulations and how to comply with them. This may include import, export, data protection, packaging and ethics.

Having strong relationships with distribution partners, suppliers and manufacturers with the relevant global expertise ensures you can understand and maintain compliance with country-specific regulations. Leveraging access to real-time data and knowledge across the globe provides a solution to the challenges companies face when distributing IMPs worldwide.

2. Ensure the quality and safety of IMPs

It is vital to maintain the quality and therefore safety of the IMP as required by the standards set out by the Medicines and Healthcare Products Regulatory Agency (MHRA). A distribution strategy considers the relevant quality standards and maintains a robust quality assurance process throughout the clinical trial supply chain.

At CSI, we have expertly controlled storage facilities, are licensed by the MHRA and have a quality management system that ensures full compliance with distribution requirements. Our storage and distribution service is fully integrated and monitored at every step of the supply chain, including:

• Good Distribution Practice (GDP)

• Good Storage Practice (GSP)

• Temperature-controlled cold (2–8°C)

• Ambient storage (15-25°C)

• Stock batch traceability, products recall in place

• Vaulted storage for controlled medications (Schedules CII–V)

• Secondary labelling and assembly if required

• Highly secure environment

3. Ensures a cost-effective supply chain

A well defined clinical trial distribution strategy will maximise cost savings throughout the supply chain. By forecasting the supply chain, you can identify risks and mitigate them prior to conducting the trial. This will help to prevent making changes during trial conduct which can incur significant costs.

With a well-forecasted clinical supply chain, you can include detailed consideration of trial design, or study-specific lead times, kit designs, country-specific challenges, and logistics associated with manufacturing, packaging, and distribution of supplies, particularly where product blinding is involved.

CSI is an experienced distribution partner

CSI has extensive expertise in supply chain management and distribution. We understand where your supply chain can be optimised and implement effective processes and technology that improve your operations. We efficiently and cost-effectively distribute IMPs to packaging agents, trial sites, patients, or warehouses to ensure your products are ready for use.

Our supply management and distribution solution ensures pharmaceuticals, CROs and CMOs can operate efficiently. This helps to save time, money and resources across the entire clinical trial supply chain.