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    Biostorage Solutions

    checkmark  cGMP BioStorage

    checkmark Logistics Management

    checkmark 24/7/365 monitoring

    checkmark 21CFR11 compliant

    biostorageYour biospecimens are the cornerstone of your research. Proper management, bioprocessing, and storage of these assets ensure their viability for use in your ongoing research.

    Most organizations lack access to – or the ability to commit – the facilities, resources, and expertise required to manage their clinical trial and research biospecimens correctly.

    ProMedDx was founded by biotech and cryo-preservation professionals who understand the importance of efficiency and compliance in biospecimen storage and distribution.

    We leverage our experience and expertise to provide customized storage solutions that prepare, preserve, and protect – your biospecimen assets for the future.

    Better BioStorage

    More than a biorepository, ProMedDx is your strategic partner in cold-chain logistics and long-term storage, and management of critical temperature and regulated biologics.

    Our comprehensive services provide:


    Logistics Management

    ProMedDx ensures that your assets are accessible for on-demand retrieval and shipment while maintaining required temperatures and chain of custody as specified in your protocol. Our ProMedDx Rockhopper™ data management system is:

    • 21 CFR 11-compliant
    • Fully auditable
    • Tracks chain of custody
    • Web portal
    • Inbound/outbound scheduling, tracking, and management of shipments
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    Storage Features

    • State-of-the-art cGMP-compliant storage facility
    • Fully validated and mapped backup freezers
    • Onsite storage capacity of more than 10,000,000 specimens
    • Controlled and monitored at any temperature:
      • Vapor phase liquid nitrogen storage (<-135°C)
      • Ultra-low storage (-70°C to -90°C)
      • Frozen storage (-15°C to -25°C)
      • Refrigerated storage (2°C to 8°C)
      • Ambient storage (20°C to 25°C)
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    Security Data

    Security and Control

    • Backup generators and redundant HVAC systems
    • 21 CFR 11-compliant 24/7/365 monitoring system and alarm response
    • Controlled access to all storage units
    • Redundant security systems for whole building and The Biorepository
    • Monthly reporting of units and activity
    • Secure Web access clinical trial support
    • Temperature-controlled lab relocation services
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    Clinical Trial Sample Management

    Precise sample management is a vital component of today’s clinical trials. The post-trial contribution of study samples may include retesting for data or regulatory compliance, or serve as the vital resource in the development of a companion diagnostic (CDx). A comprehensive specimen management plan, including centralized biostorage, should be a part of your initial trial plan.

    ProMedDx biostorage services deliver precise specimen management including:

    • 21 CFR 11-compliant inventory management system
    • Centralized specimen storage
    • Trial-specific repositories and specimen registration
    • Electronic temperature monitoring of storage chambers at all thresholds
    • In-place disaster recovery/business continuity plans:
      • Redundant at-temperature storage chambers
      • Emergency power supply
    • Web portal secure repository access and management
    • Certified distribution and shipping logistics
    • Available scalable capacity
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    Cell Banking

    Storing the cells of specific genomes for future use requires precise bioprocessing, handling, and inventory controls to ensure cell identity, purity, and viability. ProMedDx delivers these services within our biostorage capabilities, and offers the following:

    • cGMP-compliant
    • Storage conditions (between -80°C and -190°C)
    • Inventory and storage of cell bank vials
    • Inspection/verification of sample identity and label integrity
    • Multi-layered storage chamber and facility security
    • Complete chain of custody from registration to distribution
    • Long-term storage
    • Certified distribution and shipping logistics
    • Next-day shipping to your site
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    Why Outsource the Storage of your Assets?

    Outsourcing your biospecimen storage to ProMedDx reduces the budget impacts of maintaining your own dedicated storage resources, equipment, and physical space. Our flexible and scalable services meet your changing storage needs and provide secure, cGMP-compliant, temperature-controlled, and monitored off-site storage of your materials in any configuration. We can provide certified transport and relocation of your freezers to our site, as well as offer temperature-controlled distribution of your stored samples on-demand.

    The ProMedDx client-focused biostorage model is not a “one size fits all” solution. Our team works with you to understand your needs and to deliver a strategic, compliant, custom cold chain solution that adds value to your business.

    Ready to get your biostorage quote?
    Testimonial Header Image

    "ProMedDx’s team support and Biorepository has allowed us to quickly troubleshoot, identify, and respond to client observed performance of our testing systems.”

    - Senior Quality Project Engineer, European-based global provider of Diagnostic Assays