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April 4, 2024


Why now is the time to adopt agility in your clinical supply chain

Sarah Hrycyk

Marketing Programs Manager

Clinical supply labeling is a crucial aspect of clinical trial management and pharmaceutical research. It involves the creation and application of labels on investigational drug products, medical devices, and other supplies used in clinical trials. Proper labeling is essential for ensuring the safety, traceability, and regulatory compliance of clinical trial materials.  

Read on to discover 3 key aspects of clinical supply labeling and how Loftware’s cloud solutions address these challenges.  

Part 1: Understanding the landscape 

The global clinical trials market has experienced significant changes in recent years, driven by factors such as regulatory changes, therapeutic innovations, and the Covid-19 pandemic. These changes have led to a large increase in the number of trials conducted worldwide, with an emphasis on new modalities and emerging markets.  

The rise of biologics, adaptive trials, and decentralized clinical trials has added complexity to labeling requirements, necessitating a more agile approach. Moreover, regulatory changes, such as the EU Clinical Trials Regulation, have further pushed the need for more vigorous labeling capabilities.  

Part 2: Key elements of a purpose-built solution 

A purpose-built clinical supply labeling solution must offer several essential features to meet the demands of modern clinical trials. Below are some of the solution demands to deliver GxP-compliant labeling with consistency, accuracy, and speed. 

  • Automated design and approval: Streamlining label and booklet design processes through automation, reducing manual effort, and ensuring compliance with regulatory standards. 

  • Phrase and translation management: Facilitating efficient management of translated text and phrases across multiple languages, optimizing costs, and accelerating processes.  

  • Regulatory rules engine: Incorporating tools to ensure compliance with country-specific regulations, simplifying label design, and content management.  

  • Patient and kit label randomization: Enabling randomization of patient and kit label data to meet the diverse needs of clinical trials. 

  • Flexible production print capabilities: Supporting agile production models, such as Just-In-Time (JIT) or on-demand printing, to accommodate evolving trial protocols.  

Part 3: Implementing and realizing value 

Implementing a purpose-built labeling solution requires careful planning and execution. Leveraging cloud-based solutions can simplify implementation, reduce risk, and enhance collaboration across the organization. Moreover, the shift towards these cloud-based solutions accelerates time to value and fosters industry-wide collaboration.  

In conclusion, embracing agility for success is paramount for organizations to navigate the complexities and rapidly evolving landscape of clinical trial supply labeling. By adopting purpose-built solutions equipped with essential features and leveraging innovative implementation approaches, companies can streamline operations, ensure compliance, and accelerate trial processes. With the right tools and strategies in place, clinical and pharmaceutical research organizations can navigate challenges effectively and drive innovation in clinical research.  

Where can I find out more information?  

Downloadthe full report to learn more aboutadopting agility in your clinical supply chain and how the benefits of Loftware's cloud-based labeling solution could translate to your organization. 

  • Cloud
  • Regulatory
  • Supply Chain
  • Clinical Trials
  • Prisym 360