Diamind Solutions

Bio-sample/Specimen Tracking: Ensuring Precision and Compliance in Sample Management

Effective specimen tracking is essential for accurate data collection, compliance, and seamless coordination in clinical trials. The Bio-sample/Specimen Tracking module of the Diamind Clinical Trials Management Solution (DCTMS) delivers an integrated platform for managing biological samples and specimens throughout their lifecycle.

Key Features

  • Customizable Kit Management:
    • Group specimens into kits for consistent handling and tracking.
    • Configure kits for global or site-specific availability.
  • Dynamic Sample Tracking:
    • Manage collection, processing, storage, and analysis workflows with real-time updates.
    • Support collection of multiple specimen types across different visits.
  • Custom Form Builder:
    • Design and manage forms for sample collection, lab results, and process metadata.
  • Access Control:
    • Define permissions for specimen collection, result entry, and data access based on required workflows.
  • Integrated Workflow:
    • Seamlessly integrates with patient enrollment, visit management, and finance modules.
  • Regulatory Compliance:
    • Enables compliance with global regulatory standards and Good Clinical Practice (GCP) guidelines.

Description

The Bio-sample/Specimen Tracking module in the Diamind Clinical Trials Management Solution (DCTMS) offers a robust and integrated platform for managing the lifecycle of biological samples and specimens in clinical trials. From collection to analysis, this module ensures precise tracking, secure handling, and seamless data integration, enabling researchers to maintain compliance and focus on insights rather than administrative tasks.

With customizable workflows, the module allows users to create and distribute specimen kits tailored to trial protocols, manage multi-type sample collection across visits, and track specimens in real-time. It includes a powerful form builder for designing custom collection and results forms, enabling accurate data capture and ensuring integration with patient and trial management workflows. Role-based access controls further enhance security, allowing only authorized users to handle specific aspects of specimen management, from collection to data entry and analysis.

The Bio-sample/Specimen Tracking module is designed to scale with the complexity of modern clinical trials, including multi-site, multi-country studies. By automating workflows, maintaining a robust chain of custody, and integrating finance tracking for specimen-related events, it reduces errors, increases efficiency, and ensures compliance with global regulatory standards. This comprehensive solution empowers researchers to confidently manage biological specimens, ensuring data integrity and accelerating the path to impactful discoveries.

How It Works

  1. Kit Creation and Distribution:
    • Design specimen kits tailored to trial protocols, complete with labels, collection forms, and instructions.
    • Distribute kits globally or locally, with site-specific customization as needed.
  2. Real-Time Tracking:
    • Monitor specimen movement, from collection to processing and analysis.
    • Ensure chain-of-custody documentation for every step.
  3. Data Collection and Integration:
    • Capture data directly into the DCTMS platform via integrated forms.
    • Link specimen data with patient records and trial events for streamlined reporting.
  4. Event-Based Workflows:
    • Automate triggers for specimen collection and tracking tied to patient visits or milestones.
  5. Compliance and Security:
    • Maintain complete audit trails and adhere to data privacy and handling regulations.

Why Choose Our Specimen Tracking Module?

  • Efficiency: Simplifies complex workflows and reduces manual errors in specimen handling.
  • Transparency: Provides clear visibility into specimen availability and status across all trial sites.
  • Scalability: Adapts to trials of any size, including multi-site and multi-country studies.
  • Compliance: Ensures adherence to regulatory standards for specimen handling, storage, and documentation.

Integrated Finance Capabilities

This module is linked to the Finance Management system, enabling:

  • Automated tracking of financial events tied to specimen collection and analysis.
  • Simplified site payments for completed specimen-related tasks.

Enhancing Trial Outcomes

The Bio-sample/Specimen Tracking module supports:

  • Accurate Data Collection: Ensures specimen integrity and proper documentation.
  • Streamlined Operations: Automates workflows and integrates seamlessly with other trial systems.
  • Improved Compliance: Provides a robust audit trail and meets stringent regulatory requirements.

Proven in Practice

From managing diverse specimen types to supporting complex global trials, the Bio-sample/Specimen Tracking module has been tested and validated in a range of research environments. Its robust features empower teams to focus on insights and outcomes rather than administrative burdens.

Take Control of Specimen Management
Contact us today to discover how our Bio-sample/Specimen Tracking module can streamline your trial workflows and ensure data integrity.