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      • Menu IconMass Spectrometry Services
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                                                            • Home
                                                            • Clinical Trial Sample Management And Storage

                                                            Comprehensive US-Based Central Lab Services For Clinical Sample Collection, Processing, Testing, And Storage

                                                            • Customized Kits For Collecting, Storing, And Distributing Biological Specimens And Data, Ensuring Protocol Compliance And Timely Delivery For Sponsors
                                                            • Clinical Trial Sample Management And Storage Services That Ensure Regulatory Compliance And Ethical Standards
                                                            • Real-Time Sample Processing Service For Fast And Efficient Processing Of Biological Samples For Biobanking And Bioresearch
                                                            • Extensive Access To Testing Options, Providing Valuable Insights Into Diseases, Treatments, And Biomarkers

                                                            Regulated And Inspected By:

                                                            Good Laboratory Practice for Nonclinical Laboratory Studies | NorthEast BioLab Food and Drug Administration (FDA | NorthEast BioLab Clinical Laboratory Improvement Amendments | NorthEast BioLab International Orgaization for Standardization |NorthEast BioLab

                                                            Provide Your Bioanalysis Study Details

                                                            We Will Respond Within 1 Business Day

                                                            Lab
                                                            0+ Years Of Bioanalysis
                                                            0+ Small/Large Molecule Studies
                                                            0+ Custom Bioanalytical Assays
                                                            0+ Investigational Drugs
                                                            0+ 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.
                                                            Pharmacokinetic and Biomarker Sample Matrices | NorthEast BioLab

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

                                                            Connect With Us For A Reference Call With Them!

                                                            VP, Bioanalytical Development

                                                            “NorthEast BioLab is the most responsive and thorough bioanalysis lab services CRO.”

                                                            VP, Biomarker Development 

                                                            NorthEast BioLab is a responsive, collaborative, and reliable partner

                                                            Executive Director, Pharmacokinetics

                                                            We trust NorthEast BioLab to design and execute streamlined, impactful bioanalytical projects

                                                            President & CSO, Biotech

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

                                                            Sr. Associate Dir., Clinical Trials

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

                                                            Co-Founder, Biotech & University PI

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

                                                            VP, PK PD Analysis

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

                                                            Head, Bioanalytical Development

                                                            “NorthEast BioLab goes the extra mile. We look forward to more meaningful collaborations.”

                                                            Sr. Dir., Bioanalytical Development & QC

                                                            NorthEast BioLab offers a science-based, hands-on approach to the latest bioanalytical platforms

                                                            SVP Quality & Compliance, Biotech

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

                                                            Director, PK

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

                                                            VP, Development Operations

                                                            NorthEast BioLab’s scientists deliver high-quality data on time and within budget

                                                            Tackle Your Clinical Trial Sample Management And Storage

                                                            Speak To Our Scientists
                                                            Clinical Trial Sample | NorthEast BioLab

                                                            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.
                                                            Real-Time Sample | NorthEast BioLab
                                                            Testing Storage Facility | NorthEast BioLab

                                                            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.

                                                            Trust Our Clinical Trial Sample Management And Storage.

                                                            Speak To Our Scientists

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                                                            • Analytical Quantitation Analytical
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                                                            • Cosmetic Testing Cosmetic
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                                                            Contact A Scientist With Your Bioanalytical Study Details

                                                            We Will Respond Within 1 Business Day

                                                            Expertise

                                                            Expertise

                                                            • Mass Spectrometry (LC-MS)
                                                            • Meso Scale Discovery Assay
                                                            • ELISA Assay
                                                            • Flow Cytometry
                                                            • qPCR Analysis, ddPCR Assay
                                                            • Western Blot, In Cell Western

                                                            Services

                                                            Services

                                                            • Pharmacokinetics (PK) Study
                                                            • ADA Assay, Neutralizing Antibody Assay
                                                            • Multiplex Cytokine Assay
                                                            • Biomarker Assay
                                                            • Cell-Based Assay
                                                            • Bioanalytical Assay Validation

                                                            Solutions

                                                            Solutions

                                                            • Clinical CRO
                                                            • GLP Laboratory
                                                            • Preclinical CRO
                                                            • Method Development, Validation, And Transfer
                                                            • Analytical Testing

                                                            About Us

                                                            About Us

                                                            • Overview
                                                            • Leadership
                                                            • Facility and Equipment
                                                            • Quality and Compliance
                                                            • Therapeutic Areas
                                                            • Why Us?
                                                            • Values
                                                            • Process
                                                            • Partners
                                                            • Careers

                                                            Resources

                                                            Resources

                                                            • Learning Center
                                                            • Blog
                                                            • Case Study
                                                            • Video Brochures
                                                            • News and Events
                                                            • Testimonials
                                                            • Contact Us
                                                            NorthEast BioLab Logo Agile Bioanalytical Services CRO
                                                            sales@nebiolab.comFollow Up On Email
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                                                            35 Worth Ave, Hamden, CT 06518

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