top of page
Contact Us
Contact Us

Six ways to maintain compliance in the clinical trial supply chain

Updated: Jan 26

The clinical supply chain is a complex process involving not only logistics, but crucially compliance. How can this be maintained?

The clinical supply chain is a complex process involving logistics and compliance. A clinical supply company must optimise their management processes to ensure compliance with local, national and international regulations.

Maintaining compliance with the various regulations throughout the clinical trial supply chain is vital to the overall trial supply process. Clinical Services International (CSI) has extensive experience in clinical trials worldwide, which has led to expert knowledge of compliance in the clinical trial supply chain. These six tips will help you remain compliant with your supply chain.

1. Identify and manage risk

Risk management protocols are essential for ensuring a smooth supply chain for clinical trials. You must address every compliance risk individually because each trial is unique. For example, each product must be kept within its specific storage conditions to remain effective and not present a health risk.

It is critical to consider risks, even if they seem obvious. Due to the complexity of clinical trials, it is possible that regulations are not followed if proper risk management is not implemented.

2. Be aware of the complexity of regulatory requirements

Imports, exports, data protection, and other regulations are different from country to country. Therefore, you need to carefully research the countries where the products are being transported to.

When you have researched the regulations in each location, your clinical supply management strategy has nothing to hide if regulators inspect your processes.

3. Implement regulatory advice

We have seen first-hand the challenges of complying with regulatory standards. Seeking advice from CSI can help you be compliant in the clinical trial supply chain. We offer:

  • Certificates of Analysis (CofAs)

  • Batch Release Certificates (BRCs)

  • Statements of Authenticity (SoFaS)

  • QP consultation

CSI stays up to date on the latest regulatory developments and have built relationships with all major pharmaceutical manufacturers. Our trusted network of suppliers is fully audited and is fully compliant with regulations, such as the Falsified Medicines Directive (FMD).

4. Maintain excellent quality control

The clinical supply chain must implement excellent quality control to maintain compliance since regulators can easily see discrepancies in the supply chain. Effective clinical supply management system that ensures appropriate systems are in place will reduce the risk of quality control falling below the required standard.

For example, products must always be transported correctly. The FMD requires that there be a unique identifier code on the packaging to be scanned throughout the clinical supply chain.

5. Role of customs agents

Exports and imports of clinical trial supplies must pass through customs and meet the regulations of each country. Therefore, in addition to doing your research, you may benefit from using local and international customs agents who can represent you at customs and process your declaration for you.

The effectiveness of a customs agent in the clinical trial supply chain depends on the complexity and the volume of products that need to be transported - but they tend to be used with high volume, highly complicated supply chains.

So, due to the nature of clinical trial supplies, using a customs agent can enable the products to be delivered in a timely manner. This will enable the clinical trials to run on time.

CSI has extensive experience acting as an Importer of Record and working with local agents to facilitate all requirements and ensure smooth sailing.

6. Plan effectively

The key to maintaining compliance in the clinical trial supply chain is to plan the entire process, as time and money can be saved with suitable organisation and having a reliable strategy.

Aside from an effective plan being able to identify risks - as highlighted earlier, it also minimises the risk of not being compliant and having products held at customs, confiscated, or rendered ineffective.

Overall, effective planning will help maintain compliance in the clinical trial supply chain.

For further information, see our blog highlighting five reasons why clinical trial supply management is crucial.

CSI implements strict operating procedures to maintain an excellent supply chain that ensures that all clinical trial supplies remain compliant.

Contact us to see how we can help your clinical supply company meet regulatory standards in the clinical trial supply chain.


bottom of page