Why RTSM Is Critical to the Success of Clinical Trials

In a world where healthcare systems are under increasing pressure to deliver faster, more cost-effective treatments, clinical trials must evolve to meet these demands. The complexity of managing trials that span across multiple sites and geographical locations, with diverse participant populations and more complex drug products such as cell and gene therapy, alongside stringent regulatory requirements, leaves very little room for error.

Randomization and Trial Supply Management (RTSM) has emerged as an instrumental tool, ensuring that clinical trials not only run efficiently, but accurately, adapting to the modern-day challenges of complex clinical research. This article explains exactly why RTSM is critical to the success of clinical trials.

What Is Randomization and Trial Supply Management (RTSM)?

While we know we need data to drive healthcare innovation, data alone is no longer enough, we need clear and transparent automated processes that can handle the complicated nature of decentralized and global clinical trials. For a clinical trial to be considered successful, it must comply with demanding regulatory requirements and establish transparency and operational efficiency.

”As clinical trials are increasingly globalized with complex footprints over hundreds of sites worldwide, sponsors and contract research organizations constantly seek to make better and faster decisions on their investigational products.“ Lefew et al.

RTSM is a comprehensive system that enables clinical trial operations to run smoothly in the face of complex clinical trial logistics, focusing on the areas of inventory management and drug distribution, while maintaining the integrity of clinical trial randomization and maintaining the blind. If a blinded study design.

Core Functions of RTSM

Participant Randomization

Participant randomization is a key component of modern-day clinical trial design, helping to increase the quality of the data and mitigate selection bias while making it easier to detect the efficacy of the treatment under investigation.

What was once achieved through the use of sealed envelopes and a table of random numbers is now governed by sophisticated digital systems, leveraging advancements in digital technology and artificial intelligence (AI) to create systems with unmatched precision.

By automating the randomization process, RTSM systems are eliminating the risk of manual input errors, ensuring compliance with complex trial protocols, and adapting seamlessly to trial design alterations, and mid-study changes.

Companies such as Perceptive eClinical offer an array of sophisticated solutions, from simple stratified or unstratified randomization lists to advanced methods like dynamic randomization, adaptive randomization, cohort designs, and in-study design adaptations, allowing the landscape of clinical trials to become more flexible and efficient than ever before.

Trial Supply Management

One of the most challenging aspects of trial logistics is undoubtedly trial supply management.  Ensuring that investigational products (IMP) are delivered to the right place, at the right time, and in the correct quantities requires precise coordination across clinical trial sites, which often span different countries and regulatory environments.

The risks associated with trial supply management errors are vast. Overstocking can lead to waste and inflated costs, while supply shortages can delay participant treatment, disrupt study timelines, and jeopardize clinical trial outcomes.

RTSM systems are mitigating such risks, some advanced systems can even reduce the burden of monitoring site stock against participant needs by automatically adapting site stock to recruitment rate, keeping waste to a minimum, and reducing the number of shipments raised.

Not only do sophisticated trial supply management systems help to improve overall cost efficiency and trial outcomes, but they are also reducing the carbon footprint of clinical trials all over the world.

Data Integration and Monitoring

Advanced RTSM systems now include sophisticated reporting suites, designed to ensure quick and efficient access to study data and metrics, tailored to study-specific data points.

Modern RTSM systems provide trial management teams with seamless data integration, offering intuitive access to critical trial metrics. These systems often enable the creation of dynamic charts and graphs for quick insights, support self-service reporting for generating ad-hoc site, participant, pack, and shipment reports, and deliver portfolio-wide views that aggregate data across studies.

With real-time updates accessible to all stakeholders, and clear alignment between the randomization of participants and supply needs, IRT allows researchers the ability to focus on trial participants and data analysis while happy in the knowledge that logistical processes are running smoothly behind the scenes.

Clinical Trial Management

The ongoing adoption of RTSM in clinical trial management is expected to drive further innovation, especially in the era of cloud-based platforms and artificial intelligence. And while the technology is compelling, clinical trial management companies such as Perceptive eClinical also offer a dedicated statistics team, randomization specialists, and sophisticated reporting suites, allowing you to accelerate your trials, reduce your costs, and safeguard your most valuable assets; your data and your participants.