Optimizing supply chain strategies – The fundamentals of transforming the traditional supply chain to the ‘supply value chain’
In an era of data analytics and the enhanced deployment of artificial intelligence, the optimization of supply chain strategies, through planning, risk mitigation and implementation through delivery, is at the forefront of ascertaining quality data outcomes in clinical trials. Delivering quality data is one of the primary deliverables in any successfully executed clinical trial. This is a necessity for clinical trial sponsors, research organization (CRO’s) and investigator sites; however, it is even more so an ethical obligation per ICH GCP guidelines to those participants who take part in clinical trials to support the curb of disease burden. ?ICH GCP is the most widely recognized standard for the conduct of clinical trials, providing guidelines for the protection of the rights, safety, and well-being of research participants with the assurance of quality and integrity during the clinical trial.
Through the mining of descriptive and diagnostic data analytics in logistics, a clinical trial supply chain strategy can be optimized into the supply ‘value chain’ strategy from the onset of a clinical trial. The supply value chain demonstrates the (i) reliability, (ii) quality and (iii) sustainability of the clinical trial supply chain activity, some of the key pillars aligned to ICH-GCP guidelines. The value supply chain prioritizes the continual safety and well-being of participants enrolled onto a clinical trial, promising scheduled, timely accessibility of clinical trial investigational products or devices, supplies, concomitant medication and ancillaries.
This is paramount in large, long-term Phase II to Phase IV clinical trials which demands larger investment with reduced timelines before the study drug potentially goes to market. For a successful drug candidate from discovery to market, the time taken is an average of 12 years with an estimated $2 billion investment pathway (Figure 1). (1) Gene therapies take up to 30 years. (2)
Coupled with this, the lack of harmonization encountered in multi-national, global clinical trials also needs to be factored into the drug development timeline, as clinical trials are conducted in diverse locations worldwide, ranging from well-established research institutions in developed countries to remote clinical trial sites in developing, low-middle income (LMIC) regions. This adds varying complexities to the clinical trial supply chain; and hence why establishing a supply value chain has become more integral over time. The transformation of the clinical trial supply chain to the supply value chain can be achieved in the following five ways:
1.????? Using a global network with clinical trial expertise
Clinical trial logistics expertise, coupled with a reliable, global network to implement an established supply value chain plan and shipping protocols for a clinical trial, aligned to the clinical trial milestones, ensures the success of continual on-time supply to clinical trial sites and its participants. This creates a sustainable supply value chain and fosters predictive use and demand planning for the clinical trial duration.
Transporting clinical trial materials globally is a critical component in the success of clinical trial execution. The complexity and sensitivity of these materials require specialized handling and logistics. Specialist logistics providers play a crucial role in ensuring that clinical trial materials reach their destinations safely and efficiently, overcoming the logistical challenges that may arise.
2.????? Navigating the roadblocks of regulatory and compliance pathways
One of the primary challenges in transporting clinical trial materials is adhering to the regulatory requirements that vary from country to country. Regulations such as Good Distribution Practice (GDP) and Authorized Economic Operator (AEO) certifications ensure that materials are handled correctly throughout the supply chain pathway. The diversity in regulatory frameworks between countries presents hurdles, requiring thorough knowledge and meticulous planning to ensure compliance and fulfilling uninterrupted supply chain demand. This is central to the continuity of the clinical trial from first participant first visit (FPFV) to clinical trial completion.
Identifying and collaborating with a trusted supply chain partner who offers expert advice on import and export regulations, whilst maintaining integrity, keeping abreast of gold standards and complying with quality managements systems, ISO, IATA and FDA requirements is important. Demonstration of adherence to compliance and such quality systems guarantees that legal and robust supply chain practices are strictly being followed and reduces potential risk to the clinical trial.
3.????? Utilization of validated packaging solutions
Clinical trial product supply safety, quality, and integrity needs to be maintained throughout the supply chain journey across a spectrum of regulated temperatures. Precision, quality and speed should remain at the center of risk mitigation, evaluating and qualifying temperature-controlled packaging solutions during the supply value chain process. For any clinical trial, this enhances the value chain, by guaranteeing that shipments are delivered within the correct cold chain and are acceptable for use to enable participant care.
A specialist logistics partner will understand the complexities of temperature control, actively managing the condition of a clinical trial shipment as it moves through the supply chain. Their experience allows them to identify and mitigate any risks associated with transporting clinical trial investigational, placebo products, devices and clinical supplies for clinical trial use.
4.????? End-to-end visibility to improve demand planning and decision making
To facilitate efficient supply of clinical trial materials it is essential to implement decision and demand planning, with end to end, real-time visibility across the clinical trial supply chain network. With technological innovations, through advanced tracking and temperature technologies this is possible through shared access to data, conforming to responsible data use and data protection and privacy acts.
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These innovative technologies are playing a significant role in addressing the challenges of transporting clinical trial materials. Temperature-monitoring devices and GPS tracking systems provide real-time data on the conditions and location of shipments. Enhanced end to end visibility, ensures potential issues are highlighted and addressed promptly.
Automated, secure integrative messaging also enables real time updates on clinical trial shipment movements from export through to delivery to close the chain of custody process. The incidental benefit of such integration is the reduction of filing hardcopy paper trail of chain of custody documentation, still allowing traceability during clinical trial audits.
5.????? Leveraging data analytics to refine the supply value chain
Finally, leveraging data analytics from the above indicators, to continually assess and enhance the value chain is the ultimate goal. By doing this, one can work towards creating supply value chain efficiency, sustainability and success from clinical trial to market. This process informs predictive clinical trial supply value chain planning which benefits those implementing and participating in such clinical trials. Subsequently the use of predictive data enables clinical trial industry decision makers, sponsors and investors at large to prudently utilize resources, reducing time and money wasted on delayed delivery models to clinical trial sites and clinics. The consolidated use of data contributes to lessons learnt, solidifying the transformation from supply chain to supply value chain into a reality.
Summary
Pre-dating the inception of clinical trials with the first randomized controlled trial (RCT) of Streptomycin in 1946, clinical trial pathways continue to encompass a host of challenges, scientifically, ethically and regulatory, with clinical trial supply chain not being unique to these challenges.
Exercising solution driven expertise in overcoming these challenges and establishing a supply value chain model is fundamental in achieving successful outcomes of future clinical trials aligned to ICH-GCP principles.
The supply value chain fundamentals instils confidence in demonstrating how the supply chain can be seamlessly supported with reduced risk and without compromising quality or compliance. This will in turn propagate medical advancements, improve patient outcomes and attract larger research and development investments with higher participant retention rates.
As more clinical trials transform, collaborating with specialty logistics providers who adopt and evolve supply chain management strategies to supply chain value strategies, the complexities encountered will reduce with regulated solutions, to not only inform clinical trial decision making and speed of execution, but holistically improve the experience of the participants and clinical trial stakeholders who endure the clinical trial journey from discovery to market.
Learn more about how Biocair can support your clinical trial logistics needs. Together, let’s pave the way for groundbreaking medical advancements.
References
Clinical Trials Supply and Logistics?Supplement,?International Clinical Trials, August 2024, pages 18-20. ? Samedan Ltd