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The Growing Complexities of Clinical Trial Supply Chain Data Flow

  • PRONAV
  • Mar 30
  • 3 min read

Prior to the introduction of the first biotech drug, insulin, in 1982, drugs were generally manufactured using simple chemical synthesis, a process with a relatively simple linear supply chain consisting of minimal separate sites(1). However, increasing numbers of biotech drugs are now being produced, requiring advanced production and manufacturing techniques and multi-nodal, geographically dispersed global supply chains. This shift in operative norms has increased the complexity of supply chains, with a rise in the number of vendors, manufacturing sites, countries, and compliance regulations involved, leading to an exponential rise in essential documentation. This poses challenges for inexperienced teams without sufficient knowledge of the complexities, risking non-compliance and delays in batch certification.


Where does Clinical Trial Supply Chain Data Come From?

Batch Certification of Compliance (COC) and release for shipment are the endpoints of the clinical supply chain. With their confirmation, the products are deemed safe to be given to patients as part of the clinical trial. Each part of the supply chain, including all manufacturing, fill-finish, test laboratory and packaging sites, have to supply extensive documentation to demonstrate compliance in order for batch certification to be successful. 


At each location (Node), documentation must be available to confirm compliance with Good Manufacturing Practice (GMP) and Regulatory requirements, as well the registered (product) particulars included in IND/IMPD filings. These include:


  • Authorizations and GMP certifications

  • Audit Reports

  • Equipment Qualification and Process Validation Protocols

  • Relevant CMC Data

  • Packaging Specifications and Artwork

  • Master and Executed Batch Record

  • Certificates of Analysis (CoAs)  

  • Deviation Investigations

  • Change Control Records

  • Storage Temperature Records 


Not only will the above documentation be required for each of the supply chain Nodes, but further documentation will be required to coordinate between the sites and at a fill-finish site, including:


  • Formal agreements between the manufacturing sites designating responsibility for each component, (Quality Technical Agreements)

  • Transportation documentation, such as temperature records

  • Importation documentation demonstrating authorization

  • Batch Release and Certificates of Compliance

  • Qualified Person Batch Certificates


If the number of manufacturing and testing sites is increased, the amount of documentation is further increased.

In addition, due to the global nature of the supply chain, these documents are likely to be in a variety of formats and some (e.g. label artwork) may be in different languages, generating further complication.


A person working on a desktop computer in a well-lit office. They wear glasses and hold a stylus. A notebook is on the glass desk.

What Are the Consequences of Poorly Organized Data?

For efficient batch certification, the batch release team (or, in the EU, the Qualified Person) must have access to and be able to review supply chain data in near real time. Poorly organized data can lead to missing or incomplete information, hindering the review process and ultimately causing delays in batch certification and shipments(2).

While this results in the loss of both time and money, the more critical concern is the impact on the clinical trial itself. Patients may not receive treatment on time, and missed opportunities to treat patients could lead to more difficult recruitment, especially in rare disease trials. This could also contribute to the deterioration of patient conditions and even the loss of life. As a result, effective clinical supply chain data management is crucial to the success of clinical trials(3).



Ampoules on a white table with open brown box, showcasing a clean, clinical setting. Boxes and ampoules create a focused, organized feel.

Conclusion

The shift in clinical trial supply chains from linear to multi-nodal and geographically dispersed networks has increased the complexity of supply chain data flows. Effective data management is essential for ensuring on-time batch certification, product release, and the overall success of clinical trials.

Our latest whitepaper delves deeper into clinical trial data management, offering insights into why these supply chains are more complex than ever, the documents required at each supply chain node, and the critical role data management plays in the process. Additionally, we outline a roadmap for implementing efficient data management practices.


Interested in learning more about strategies for mastering clinical trial data management? Download the full whitepaper today!


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