Diamind Solutions

Drug / Device / IP Management: Comprehensive Trial Supply Oversight

Effective management of investigational products (IP), whether drugs, devices, or other materials, is essential for the success of clinical trials. The Drug/Device/IP Management module of the Diamind Clinical Trials Management Solution (DCTMS) provides an integrated platform to streamline supply chain logistics, enhance accountability, and ensure compliance.

Key Features

  • Multi-Site Support:
    • Manage products across manufacturers, depots, site pharmacies, and storage facilities.
    • Track shipments and inventory at every location, including site-specific fridges and storage units.
  • Complete Drug/IP Tracking:
    • Monitor inventory from production to administration.
    • Track all transactions, including shipments, quarantines, returns, and replacements.
  • Integrated Drug Allocation:
    • Fully linked with the randomization module for automated drug assignment during patient enrollment.
  • Unblinding Request Management:
    • Secure workflows for unblinding requests, ensuring compliance with trial protocols.
  • Cold Chain Management:
    • Maintain cold storage and temperature tracking for sensitive investigational products.
  • Regulatory Compliance:
    • Validated processes to meet global standards, including FDA, Health Canada, and EU requirements.

Description

Managing investigational products (IP), whether drugs, devices, or biologics, is a critical component of clinical trials. The Drug/Device/IP Management module in the Diamind Clinical Trials Management Solution (DCTMS) delivers an integrated system to handle complex supply chain logistics while ensuring regulatory compliance. From production to administration, every step is tracked and managed, offering complete visibility into inventory, shipment, and allocation processes.

This module supports multi-site and multi-country trials, allowing administrators to manage inventory across manufacturers, depots, site pharmacies, and storage facilities. With features like automated drug allocation, quarantine handling, and secure unblinding workflows, it eliminates manual errors and enhances efficiency. Additionally, its robust cold chain management capabilities ensure the integrity of temperature-sensitive investigational products, while integrated alerts and real-time monitoring keep stakeholders informed about inventory levels, shipment statuses, and compliance risks.

By connecting seamlessly with the randomization module, the Drug/Device/IP Management module ensures that investigational products are allocated accurately during patient enrollment. Whether it’s tracking product usage or generating detailed audit trails for regulatory reviews, this module provides a streamlined and compliant solution to meet the needs of modern clinical trials. Its ability to handle complex scenarios, such as direct-to-patient shipments or rapid allocation in emergency settings, makes it an indispensable tool for advancing trial efficiency and outcomes.

How It Works

  1. Centralized Inventory Management:
    • Gain visibility into IP availability across all trial sites and depots.
    • Allocate products efficiently based on trial demands and storage capacities.
  2. Automated Allocation During Enrollment:
    • As patients are randomized, the system automatically assigns the appropriate IP, minimizing manual errors and delays.
  3. Real-Time Monitoring and Alerts:
    • Receive notifications for low inventory levels, shipment status, or cold storage deviations.
  4. Secure Quarantine and Replacement Processes:
    • Safeguard patient safety by isolating compromised products and managing replacements efficiently.
  5. Detailed Audit Trail:
    • Maintain a complete record of IP activities, ensuring transparency and compliance during regulatory audits.

Why Choose Our Drug/Device/IP Management Module?

  • Efficiency: Reduces the time and effort required to manage complex supply chains.
  • Accuracy: Minimizes errors in drug allocation and administration with integrated workflows.
  • Scalability: Supports multi-site, multi-country trials with customizable settings for local regulations and logistics.
  • Compliance: Fully validated processes designed to meet the highest standards of regulatory oversight.

Enhancing Clinical Trial Outcomes

With the Drug/Device/IP Management module, your trial sites can:

  • Ensure the right product is delivered to the right patient at the right time.
  • Maintain the integrity of investigational products through robust tracking and monitoring.
  • Streamline processes to focus on delivering high-quality care and trial results.

Proven in Action

This module has been successfully implemented in diverse global trials, including those requiring complex cold-chain logistics and rapid drug assignment for acute care settings. From shipment tracking to automated allocation, our solution ensures that trial supply management is no longer a bottleneck.

Take Control of Your Trial Supply Chain
Reach out to us today to learn how our Drug/Device/IP Management module can optimize your clinical trial logistics and ensure regulatory compliance.