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    20+ Years Of Bioanalysis
    600+ Small/Large Molecule Studies
    400+ Custom Bioanalytical Assays
    200+ Investigational Drugs
    1,000+ Biomarker & Cytokine Assays

    Clinical Trial Sample Management And Storage

    NorthEast BioLab offers US-based clinical sample collection, processing, testing, and storage services. Central lab services are crucial in drug development as they ensure the quality and integrity of clinical samples collected from study participants. Our primary central lab services include:

    Clinical Sample Collection: Kitting & Logistics

    Our Clinical central lab services include collecting, storing, and distributing biological specimens and data for sponsors. Customized kits tailored to your clinical protocol’s specific needs, with collection and shipping materials for each visit, including:

    • Tailored manual for specimen collection and handling instructions to ensure protocol and regulatory compliance, including troubleshooting tips, contact information, and FAQs
    • Pre-labeled collection tubes, color-coded by sample type and anticoagulant used, to minimize errors and reduce sample handling time
    • Clinical protocol-specific samples for measuring drug concentration, safety, efficacy, and mechanism of action, collected at predefined time points
    • Customized air bills and laboratory requisition forms to streamline paperwork and ensure timely delivery
    • Contents wrapped in order of use, labeled with clear instructions, and including necessary supplies (needles, syringes, alcohol swabs, gloves, etc.)
    • Resupply kits processed within 10 business days to meet clinical site needs, with supply-only orders processed in 5 business days; expedited requests supported to meet urgent needs.

    Sponsors Love Our LC MS Laboratory Mass Spectrometry Services For Top Quality And Industry Leading Turnaround

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    NorthEast BioLab is by far the most responsive and thorough bioanalysis lab services CRO.

    We partnered on several programs and found NorthEast BioLab responsive, collaborative, and reliable.

    We trust NorthEast BioLab to design and execute the most streamlined and impactful bioanalytical projects.

    We found their integrity as refreshing as readiness to provide creative scientific input and high-quality data.

    We have worked with NorthEast BioLab for over ten years given their commitment to highest quality bioanalytical data.

    NorthEast BioLab tremendously supported us in reproducing our critical lab discoveries for drug metabolism.

    NorthEast BioLab always exceeds expectations on bioanalytical assay development, validation, and sample analysis.

    NorthEast BioLab truly goes that extra mile, and we hope to continue enjoying seminal interactions with them.

    NorthEast BioLab presents a science-based, hands-on, no-frills approach on the latest bioanalytical platforms.

    We are thrilled to complete our bioanalytical studies with their top quality and incredibly responsive team.

    We worked closely to implement the most efficient and cost-effective bioanalytical assay for our PK Studies.

    As a small company, our vendors are key members of our project teams. The scientists at NorthEast BioLab are technical experts, who produce high-quality data, on-time, and on-budget.

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    Clinical Trial Sample Management And Storage

    Clinical samples are crucial for measuring the pharmacokinetics, pharmacodynamics, safety, and efficacy of investigational drugs. We maintain a complete chain of custody for the samples to ensure absolute regulatory compliance and ethical standards. NorthEast BioLab offers comprehensive sample management services, such as:

    • Proper storage and preservation: We maintain biospecimen viability, stability, and molecular integrity with various storage options, such as ambient (4°C), frozen (-20° to -80°C), cryogenic (-150°C), and combination options. Our state-of-the-art storage facilities accommodate different temperature requirements and sample volumes, ensuring the safety and stability of the samples. We also have backup generators and alarm systems to ensure the safety and stability of the samples.
    • Tracking and documentation: Label biospecimens with unique identifiers and track their lifecycle while complying with ethical and regulatory requirements. We provide pre-printed labels, shipping instructions, tracking numbers, and courier services for the sample shipment. We also coordinate with the clinical sites and the central lab to ensure timely and secure delivery of the samples.
    • Inventory management: Efficiently manage biospecimen availability, including recordkeeping and planning for replenishment, disposal, and contingencies
    • Sample retrieval and distribution: Retrieve and distribute biospecimens following standardized protocols while respecting scientific merit. We can store and handle a wide range of sample matrices, such as plasma/serum, whole blood, dried blood spots, translucent matrices (tears, urine, synovial, cerebrospinal, aqueous, etc.), tissues (arterial, lung, kidney, tumor, tendon, skin, etc.), and more.
    • Compliance with regulatory guidelines: We adhere to applicable laws and regulations governing biospecimens and biobanks.

    Real-Time Sample Processing

    Our Real-Time Sample Processing service provides fast and reliable processing of biological samples to our sponsors. These central lab services aim to save sponsors time, money, and resources while enhancing the efficiency and quality of biobanking and bioresearch. Here are the common sample processing services offered by us:

    • PBMC isolations and clinical sample processing: Within 8-24 hours of collection, Real-Time Sample Processing efficiently isolates and processes PBMCs from whole blood samples. By utilizing the latest technologies and methods, it ensures high-quality and viable cells, which are crucial for accurate research results and biomarker analysis.
    • DNA and RNA extraction services: Real-Time Sample Processing extracts DNA and RNA from various sample types, including blood, tissue, and saliva. The extraction methods used are automated or manual, based on sample quality and quantity. Additionally, it offers quality control, quantification, normalization, and storage for the extracted nucleic acids, which are essential for downstream analysis.

    Access To Testing At Storage Facility

    Our central lab services offer unprecedented access to testing services, providing valuable insights into molecular mechanisms and biomarkers of diseases and treatments. This enhances the quality, efficiency, and biobanking of bioresearch. The service provides direct access to a wide range of clinical sample testing options, including:

    • Pharmacokinetics: We measure drug absorption, distribution, metabolism, and excretion in the body using LC-MS, ELISA, or MSD platforms.
    • Immunogenicity: We investigate how drugs trigger immune responses, measuring immunogenicity using ADA and cell-based NAb assays on MSD and multi-mode ELISA platforms.
    • Cytokine detection and quantification: We detect and measure cytokines, proteins involved in regulating inflammation and immunity, using ELISA, MSD, or Luminex platforms. Cytokines can be measured in biological fluids such as plasma, serum, or saliva.
    • Immunophenotyping using flow cytometry: Immunophenotyping analyzes cell types based on their surface markers using flow cytometry. It provides valuable insights into the immune system and disease mechanisms, enhancing research and clinical efforts in biomarker discovery and biobanking.
    • Gene expression analysis and pharmacogenomics using SNP genotyping: We offer gene expression analysis and pharmacogenomics using qPCR and ddPCR platforms. Gene expression reflects cellular state and function under different conditions, while pharmacogenomics studies how genetic variations affect drug response and metabolism.
    • Novel pharmacodynamics biomarker assay development and validation: We develop and validate assays adhering to regulatory guidelines and standards, utilizing immunoassays, mass spectrometry, flow cytometry, and more.

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