Impact analysis of Just in Time packaging and labeling on clinical supply chain

Abstract

Clinical supply chain is in intense pressure for better management due to factors like globalization of clinical trials and increase of triple blinded clinical studies. Traditional supply chain practices don’t allow room for flexibility in shipments for medication kits as they are packaged and labeled in central depot. This has led to an increase in clinical wastages to the tune of 40-60%. However, if options for flexibility are provided to an investigator then these high wastages can be reduced to comfort levels and R&D investments from Pharma Companies can be streamlined to some extent. This can be done if organizations can bring packaging and kitting of medication drugs nearer to clinical trial sites. This will also assist clinical supply chain vendors to plug supply-demand mismatch for majority of trial sites. Just-in-time (JIT) Packaging and Labeling is considered to be one of the solutions for achieving greater control over clinical trial supplies.

“Implementing JIT labeling and packaging process effectively can potentially reduce clinical trials wastes in a range of 30- 50% depending upon some factors.”

VP, Sales in a Global Courier Company

Introduction

Majority of clinical supply chain vendors still follow traditional supply chain practices where all the packaging, labeling, kitting and collation activities are done at central depot level. Clinical trials these days have become more diverse, challenging and reaching out to more geographies which needs better supply chain management. According to an analysis the clinical supplies are experiencing wastage to the tune of 40-60% which is pretty high.

Industry needs to bring more innovations in the supply chain processes so that they can assist pharma sponsors in saving precious investment some part of which gets wasted. Bringing packaging and kitting processes near to clinical trial sites can be very useful (in) streamlining clinical supplies. And Just in Time (JiT) clinical packaging and labeling can be very helpful in evolving clinical supply chain in this way.

JIT Packaging and Labeling is a process taken care at depots. Vendors if authorized and certified by FDA and/or other regulatory authorities can only provide this service. All protocol related to information like protocol number, expiry dates, quantities to be used, etc. are labeled just before dispensing to a particular clinical trial site. This needs a robust electronic and web based systems to be in place. Once data and results for clinical trial site are triggered by IVRS/ IWRS systems the process can effectively precede. JIT Packaging and Labeling can assist clinical trial managers with more flexibility during clinical trials. There may be many incidents like patient return, frequency/ volume increase/ decreased on a trial site, etc. those need to be take care of to avoid unnecessary wastes. This concept is not new to the market, still industry expert feels that the concept is on growth trajectory as pharma and supply chain companies are in dire need for efficiency.

Key Issues faced by clinical supply chain for global multi-center clinical trials

There are various issues which are affecting the clinical supply chain. Clinical trials can’t be stopped and pharma companies are forced to provide overage supplies of up to 150% depending upon the risk factors. These issues are pushing for bringing innovative methods like JiT packaging and labeling in the clinical supply chain. Some of the biggest pain points of this segment are discussed as follows:

• Supply demand mismatch: Most of the clinical trial sites complain about supply-demand mismatch for clinical trial materials. Forecasting actual number of patient enrollment is a very challenging task. Vendors generally follow the initial decided timelines for shipments but it often confronts with unexpected issues like customs, patient enrollment issues, lead time, quality issues, etc.
• Less Flexibility: If there is a change in study or if forecasted supply varies with actual need of supply then one leads to high overage and wastes creating high wastage in investment for R&D. And CTSOs (Clinical Trial Supply Organization) generally follow a fixed protocol for supply chains leaving less room for on-time changes required in supply of clinical materials due to protocol amendments.
• Geographical Issues: Regulatory requirements in emerging markets are very dynamic. There are other linguistic requirements as well according to regulatory point of view. Most of the IMPs and Non-IMPs are manufactured in Western Europe and other processes like packaging and labeling are also done here only. Many times the shipments are send back or get trapped in customs due to improper paper work, regulatory issues, quality issues, etc. leading to huge time and investment wastage.

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