Clinical Trials Supply Chain: How to Respond to Recent Transformations

Concept of flexibility acting as driving force behind industry’s swift response to COVID-19.

During the first wave of the pandemic, there was industry-wide recognition of the need for speed. Players at all stages of the supply chain proactively and collaboratively worked to accelerate trial processes for COVID-19 vaccine candidates.

The ‘direct-to-patient’ production and supply model saw an increase in popularity, supporting patient recruitment and retention in periods of lockdown. There was a drive towards patient-centricity, which has only continued as sponsors demand more convenient and accessible ways of distributing products to patients. When it came to inventory, there was greater impetus to move from traditional production and supply models, such as batch production, to more flexible on-demand or just-in-time (JIT) models. Today, we continue to see the benefits of JIT labeling. For example, JIT and on-demand techniques eradicate a lot of the logistical challenges and costs of dealing with overage or having to relabel in the event of an expiry change.

Labeling impact

When it came to clinical trial booklet production, the established processes and lead times needed to be cut. Typically, these booklets would take three-months or more, would need to be outsourced to specialists, and have over 50 pages of content to collate, agree, translate, and design. During the height of the pandemic, these essential printed materials needed to be designed and produced far quicker. The European Commission therefore introduced labeling flexibilities to facilitate faster production and temporary exemptions to standard labeling protocol were permitted.1 These allowed EU Member States to market a COVID-19 vaccine with outer and immediate packaging in English only, provided they supplied electronic translations of the product information in all EEA languages. QR quotes were used to provide national translations of the package leaflet.

Within this context, many providers saw critical business advantages to moving in-house labeling functions. One such company, RxSource,2 invested in a cloud-based clinical trials labeling solution, which gave the company control over the design and creation of labels in-house. This enabled RxSource to package and supply medicines in as little as 48 hours. With shorter lead times and their own automated in-house labeling and printing system, the company was able to reduce the risk of mislabeling and ensure regulatory compliance.

Even without the pandemic, the clinical trials industry would have needed to adapt and accelerate its systems. New clinical trial regulations, such as the EU Clinical Trial Regulations and its Annex VI requirements, which require that any changes to the expiration date be physically reflected on the primary drug have influenced how many organizations handle clinical trials, specifically their labeling and packaging. The logistical challenges presented by this regulation would have driven the industry to more adaptive and efficient supply chain models, including on-demand/JIT packaging and labeling.

Since COVID, and sponsors discovery of new ways of approaching clinical trials, providers are being asked to permanently accelerate many aspects of the trial process. In early 2022, the UK government proposed legislative changes that intend to improve the speed and efficiency of approvals in clinical trials. They also intend to continue to allow parallel amendment submissions for different documents therefore speeding up UK processing times.3 Equally, and in order to be more responsive, CROs, CDMOs and CSOs (clinical supplies organizations) are also seeking to operationalize the more agile production models deployed during the pandemic.

The clinical trial industry has always been incredibly innovative, collaborative, and patient/ safety focused. The pandemic created an unexpected challenge, one that the industry rose to yet again. The clinical trial supply chain has done well to adapt in these precarious times and will benefit from these changes now and in the future.

Simon Jones, Loftware VP - Lifesciences Product Management

References

  1. European Medicines Agency, Questions and Answers on labelling flexibilities for Covid-19 vaccines
  2. Loftware: Global Clinical Trial Supplies Specialist RxSource invests in clinical labeling software to enhance service offering, RxSource: Global Clinical Trial Supplies Specialist RxSource Invests in Clinical Labelling Software to Enhance Service Offering
  3. The Medicines and Medical Devices Act 2021 (please see the following link)