TSM

The BSI TSM is designed to offer complete oversight of clinical trial supply management by efficiently controlling study materials and inventory. It enables sites to place orders within pre-approved study material budgets and facilitates the straightforward shipment and tracking of these materials. Upon receipt, sites can perform necessary accountability checks, and the supply information can support Sunshine Act reporting requirements.

Comprehensive Functionality

The solution handles various aspects of trial supply management, including importing study material items, creating and tracking orders and shipments, monitoring site material accountability, and budgeting at both trial and site levels. It also offers features like shipment document creation and low stock or overdue shipment alerts. Users can even select new study sites based on available equipment and maintain a real-time overview of all materials across studies.

User-Friendliness and Integration

The web-based HTML5 user interface is modern and intuitive, enhancing work efficiency. BSI TSM can be implemented rapidly using BSI's standardized processes without the need for external system integrators, ensuring a seamless configuration and rollout.

Cost-Effectiveness

BSI TSM provides a low total cost of ownership by minimizing training expenses and accelerating data entry, thereby saving on time and resources. The software is designed with open architecture, allowing for innovative upgrades and integration without reliance on third-party vendors.

Comprehensive Reporting

Users can benefit from advanced reporting capabilities, configuring personal reports based on all available data and exporting them in various formats such as Word, Excel, or PowerPoint, or using built-in reports.

Regulatory Compliance

The system aligns with critical regulatory standards such as 21 CFR Part 11, ICH-GCP E6(R2), and GDPR, ensuring data protection and compliance, providing users with peace of mind regarding safety and security.

Controlled Access

BSI TSM supports controlled access for different study partners through a sophisticated access rights system, allowing sponsors, CROs, CRAs, and sites to interact efficiently within a secure framework.