Overview

Clinical trials are the backbone of medical research, paving the way for new therapies, drugs, and medical devices. However, the complexity of conducting these trials is immense, involving numerous logistical challenges.

One critical component that can significantly streamline the process is the Trial Supply Management (TSM) system. TSM systems are specialized software solutions designed to manage and optimize the supply chain of clinical trials. They ensure that the right drug, in the right quantity, reaches the right location, and ultimately, the patient at the right time.

TSM is indispensable in clinical trial management and in this article, we will explore how it can contribute to the success and efficiency of your clinical studies and why you should pick BSI TSM as a vendor.

Why do you need a TSM system?

Optimized Supply Chain Management

One of the primary benefits of TSM systems is the optimization of the supply chain. Clinical trials often span multiple sites across various geographical locations, each with its own regulatory requirements and logistical challenges. TSM systems provide a centralized platform that optimizes the supply chain, which includes inventory and distribution planning. This ensures that supplies are available on time, reducing delays that can compromise the trial timeline.

By automating the supply chain, TSM systems minimize human errors, which are common in manual processes. TSM enable real-time tracking and monitoring of supplies, providing transparency and visibility into the supply chain status. This allows for proactive management of potential issues, such as stockouts or overstocking, thereby ensuring a smooth and uninterrupted flow of trial materials leading to greater operational efficiency.

Improved Regulatory Compliance

Compliance with regulatory requirements is a significant challenge in clinical trials, especially when they are conducted across different countries. TSM systems are designed to ensure adherence to these regulations by maintaining accurate records and documentation for all trial supplies. They facilitate the tracking of each supply batch, ensuring traceability and accountability. minimizing the risk of regulatory infractions and penalties.

Moreover, they support the preparation of regulatory submissions by generating comprehensive reports and audit trails, making it easier for trial sponsors to demonstrate compliance with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) standards.

Cost Reduction

TSM systems significantly cut costs by optimizing inventory levels and reducing waste. Predictive analytics forecast supply needs accurately, minimizing expired supplies. Efficient resource allocation and reduced emergency shipments further contribute to cost savings.

Real-Time Monitoring and Reporting

TSM systems offer real-time data and analytics for continuous monitoring of supply chain performance. Detailed reports and audit trails are essential for regulatory submissions and internal reviews, aiding in proactive decision-making and quick issue resolution.

What makes BSI TSM stand out?

BSI CTMS is built for easy integration with other eClinical systems, vendors, and CROs, and offers a range of standard automated integrations with specific EDC, payment, and eTMF vendors. Additionally, BSI offers standard interfaces to portfolio and project management tools, clinical data warehouses, active directory for single-sign-on, and more. Automated interfaces and integrations will severely improve your daily data efficiency and eliminates the frustration of receiving ever-changing file and data formatting by email or semi-automatic file transfer.

Standard System Set-up and Migration Strategy

Just like BSI has a standardized system configuration and implementation process, HERAX offer a corresponding ThreeStep Data Migration Strategy, configured to your specific legacy systems and data. Here, the migration strategy will be incorporated into the overall implementation process, timelines and scope, ensuring transparency, stakeholder buy-in, and reduced data quality issues in the final product.

The HERAX Three-Step Data Migration Strategy will help you prepare your organization’s data for continued use in BSI CTMS, by eliminating the common pitfalls during data migrations.

Conclusion

With BSI CTMS, data migration and integration becomes a part of the inherent system functionality. Data migration and integration are encouraged and is considered a way to fully utilize the system capabilities.

Employing BSI CTMS’s native functionality results in less complex data migrations, which increases data quality and speeds up implementation. Additionally, easier data cleaning/mapping results in increased operational efficiencies and ensures digital continuity for your organization’s data.