Performance Evaluation

Biospecimen Sourcing

PeploBio offers a global network of biospecimen sourcing through clinical trial sites and biobank partners, providing IVD manufacturers with high-quality biospecimens that meet the strict regulatory requirements of IVDR, FDA, and more.

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Services

Biospecimen Sourcing for IVD Manufacturers

For IVD manufacturers requiring biospecimens for their research and development, regulatory compliance is of paramount importance. We facilitate biospecimen procurement that aligns with the stringent regulations and guidelines set by IVDR, FDA, and other relevant authorities:

  • High-quality biospecimens

    Our network of clinical trial sites and biobank partners ensures access to high-quality human biospecimens, including remnant samples, that meet the rigorous demands of regulatory compliance.

  • Patient demographics

    We provide biospecimens with detailed patient demographics, enabling you to meet the specific requirements outlined by regulatory authorities.

  • Informed consent

    All biospecimens in our network are sourced with the highest regard for informed consent, ensuring compliance with the ethical considerations set forth by IVDR, FDA, and other regulatory bodies.

  • Exclusion criteria

    We work with partners to understand and apply exclusion criteria, aligning biospecimen procurement with the specific regulatory requirements of your research.  

  • Prospective collections

    For IVD manufacturers involved in studies requiring prospective collections, our network offers access to biospecimens collected in real-time for current and future research, ensuring ongoing regulatory compliance.

  • Informed consent

    All biospecimens in our network are sourced with the highest regard for informed consent, ensuring compliance with the ethical considerations set forth by IVDR, FDA, and other regulatory bodies.

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Why Choose PeploBio for Regulatory Compliance

When it comes to biospecimen sourcing, IVD manufacturers choose PeploBio for several key reasons:

  • Life sciences expertise

    With a deep understanding of the life sciences industry and regulatory landscape, we help IVD manufacturers ensure that biospecimens are sourced in accordance with IVDR, FDA, and other relevant regulations.

  • Regulatory expertise

    Our team is well-versed in the regulatory requirements of IVDR, FDA, and other relevant authorities, providing you with the assurance of regulatory compliance.

  • Diverse collection sites

    Our network encompasses diverse collection sites worldwide, allowing you to source biospecimens that align with the requirements of different regulatory regions.

  • Global network

    Our extensive global network of clinical trial sites and biobank partners ensures access to biospecimens that comply with international regulatory standards.

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Download our Biospecimen Inventory List

We offer the option to download our biospecimen inventory list, which includes details on biospecimens, including remnant samples, available through our network.

Download Biospecimen Inventory List

This inventory list outlines their compliance with IVDR, FDA, and other regulatory standards.
Download

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