Clinical trials are becoming increasingly complex, driven by many changes in the healthcare industry, including:

Technological advances across every aspect of research
A growing focus on developmental therapies for smaller participant populations or rare diseases
An ever-increasing emphasis on more individualized or genomic medicinal products

As a result, clinical trial supply management is becoming more challenging, especially in the context of post-pandemic, decentralized clinical trials with the involvement of multiple stakeholders.

This article provides insight into how clinical trial supply management experts can ensure you keep up with the ongoing evolution of clinical trial supply management, considering the latest advancements in regulatory compliance, supply chain optimization, and technological innovation.

Clinical Trial Supply Management

Clinical trial supply management encompasses a range of activities that are required to ensure a trial runs smoothly and efficiently, such as:

Trial logistics
Global distribution and planning, and
Inventory stock control and demand forecasting

These require continuous management and supervision of the acquisition, monitoring, and distribution of all clinical trial products.

More than anything, effective clinical trial supply management is vital to enable the accurate and efficient supply of investigational drugs, comparator products, or placebos to the right participants at the right time, maintaining the required compliance with regulatory standards and supporting the integrity of the clinical trial process.

The Evolution of Clinical Trials

Following COVID-19, there has been a significant increase in the integration of AI and technology into clinical trial design, and adaptations have been made to meet the rising demand for healthcare systems, including the adoption of decentralized and hybrid trials.

Moreover, the pandemic led to accelerated drug development timelines, with regulatory bodies implementing emergency authorizations to speed up the approval process, which has filtered down into the newly implemented UK government regulations which intend to simplify approval processes, encourage trial design flexibility, and position the UK as a global clinical research hub.

Global collaboration is quickly becoming a key component of contemporary clinical trials. Global, multi-site clinical trials allow data to be yielded from diverse populations, which can be shared across countries to accelerate the development of new therapeutic approaches and improve global participant outcomes.

Nevertheless, a key challenge comes from the need to navigate the varied regulatory requirements across different countries. Ensuring compliance with such a diverse regulatory landscape while maintaining the integrity of trial data can result in delays, additional costs, and ongoing administrative burdens. Sponsors face growing pressure to make faster, more informed decisions about their treatments.

In an age of rapid technological advances, the growing integration of AI, and the shift toward patient-centric trials, drug supply planning must evolve to ensure an efficient and effective supply chain for every study. Clinical trials are under considerable scrutiny for their overall carbon footprint, with increasing pressure to adopt sustainable practices in logistics, packaging, and waste management. Despite efforts to minimize their carbon footprint over the last few years, clinical supply overages remain high, which continues to be a challenge.

Enabling Effective Clinical Trial Supply Management

Drug development companies are under increasing pressure to address the rising demand for healthcare services. Working with trial supply management technology that can meet changing trial needs, along with experts who can advise on implementation and adapting to challenges, can alleviate some of the growing complexities of clinical trial management.

Companies such as Perceptive eClinical work alongside biopharmaceutical companies and CROs, ensuring trials are ready to benefit from the latest advances in local and global regulatory frameworks while optimizing supply chains. Backed by the industry’s most experienced designers and RTSM specialists, they have a catalog of procedures that support all clinical trial needs, covering study, site, and subject management, randomization and dosing, and trial supply management from lot release to destruction.

Engaging with clinical trial supply management experts can accelerate study timelines and support the challenges faced with novel supply management, such as a patient-led supply chain, and those typically faced during a trial, such as supply shortages. With pre-determined contingency plans for managing common sourcing and supply challenges, they are instrumental in driving clinical trial success, helping to protect not only the safety of study participants but also the validity of clinical data.