As a reminder, the first blog in this series highlighted the advantages of expanding clinical trials in countries beyond traditional targets. For any business across borders, it is imperative to know how the language, culture, customs and religion play a role in the transaction. Success also requires incorporating the infrastructure requirements, customs (imports/exports), documentation requisites, taxes and additional fees into the planning process.
The second blog in this series offered best practices for managing the unforeseen changes that arise in clinical trials despite thorough planning. Making sure your team has a breadth of expertise and complementing them with experienced consultants can impact your ability to manage variables seamlessly.
In addition to these factors, there are several contributors to a costly supply chain evolution, where the process is equally as critical as the result. Recent estimates suggest that supply chain logistics may account for one-quarter of an annual R&D budget. This is due to increases in temperature-controlled shipping, requests for comparators, direct-to-patient studies, “Amazon-like” tracking and other factors. Since awareness and knowledge will empower your supply chain teams to be more effective, here are a few recommendations for navigating change.
A Chilling Impact
Whether it’s a treatment for a chronic, terminal or rare disease, biologics requiring cold storage, handling and transportation are key contributors to increased costs. In 2016, the Fisher Clinical Services team noticed a significant percent increase in cold-temperature shipments compared with the prior five years. The industry forecast is for exponential increases between now and 2020. As innovators, we are testing and implementing new cutting-edge, reusable packaging designed to lower costs, reduce temperature excursions and reduce waste in the long term.
Customized Comparator Sourcing
Another challenge to a supply chain might be the requirement for a comparator drug, which is starting to rise in cases where a placebo is unethical or when co-therapies are being considered. Qualifying wholesalers when a direct approach is not viable, requires constant evaluation and monitoring based on risk assessment criteria. We create a tailored approach based on your requirements and limitations. To learn more, click here
Emerging Patient-Centric Trials
Another emerging trend is the direct-to-patient (DTP) trial that includes appointed data centers collecting key study information. While this reduces costs for multiple handling touchpoints and investigator sites, the costs increase for dispersed distribution plus reverse logistics when biological specimens are part of the protocol. The Fisher Clinical Services team evaluates each DTP request individually, offering the most cost-effective option for delivery and tracking.
Tracking and Handling Analysis
In our immediate-gratification, knowledge-savvy culture, sponsors are eager for real-time delivery information that can be tracked and analyzed easily. In the clinical world, this goes beyond arrival time to include temperature and location as well. Giving all parties access to the right data at the right time can have a positive impact on both sponsors and investigational sites for use in scheduling clinical supplies deliveries.
Overall, it’s clear that pharmaceutical companies want to streamline processes and realize efficiencies, but that is weighed against patients needing more care and ensuring compliance with patient safety regulations. “In an intricately linked world of researchers, production facilities, logistics providers, care practitioners and patients, it becomes increasingly difficult to balance these various demands without sacrificing speed or security.”
Recently presented at Insights Europe (held 4-5 April 17 in Switzerland) by Jen Worsfold, Senior Director Supply Chain Solutions, we encourage you to read our latest white paper, “What Clinical Teams Should Know About Changing Trial Logistics and How They Will Affect Development.” It provides more details on all the topics impacting the supply chain evolution along with relevant case study examples from across the globe.
Register to attend webinar ‘Changing Trial Logistics & Tactics to Overcome them’
 Pelzel, Kristina. “What’s Next for the Pharmaceutical Supply Chain?” inventory-and-supplychain-blog.com, Inventory and Supply Chain Optimization, 12 January 2017, http://www.inventory-and-supplychain-blog.com
 Pharmaceutical cold chain logistics is a $12.6-billion global industry.” Pharmaceuticalcommerce.com, 4 February 2017.
 PharmExec.com, March 17, 2017, http://www.pharmexec.com/securing-pharma-supply-chain-current-challenges-and-key-steps