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                                                            • Home
                                                            • Clinical Trials Bioanalysis CRO Lab Services

                                                            Nimble Central Lab Solutions For Your GCP Clinical Trials Bioanalysis CRO Services!

                                                            • GCP Clinical Trials CRO Bioanalytical Method Development, Validation, And Sample Analysis Lab Services
                                                            • FDA Audited, Watson LIMS Enabled Facility For Clinical Bioanalysis Assessment Of Novel Drugs, Reformulations, Or Generics
                                                            • High-Value And Reliable Clinical Bioanalysis Services Experienced With LC-MS/MS, ELISA, MSD, Luminex, Or qPCR On 500+ Projects
                                                            • Full-Service Bioanalysis Provider: First-In-Human Clinical Trials CRO For NDA From Preclinical IND Testing

                                                            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

                                                            Contact A Scientist For Clinical CRO Services

                                                            We Will Respond Within 1 Business Day

                                                            Clinical Trials Bioanalysis CRO Lab Services | NorthEast BioLab
                                                            Click below for answers to your Clinical CRO questions -
                                                            • What are Clinical Trials and associated CROs?
                                                              What are Clinical Trials and associated CROs?
                                                            • Which Clinical Bioanalysis CRO services do we offer?
                                                              Which Clinical Bioanalysis CRO services do we offer?
                                                            • Why choose us for your Clinical Trials CRO Services?
                                                              Why choose us for your Clinical Trials CRO Services?
                                                            • What are the different phases in Clinical CRO services?
                                                              What are the different phases in Clinical CRO services?

                                                            Ask Us About Your Study

                                                            Clinical Trials CRO services involve bioanalysis on first in human research studies to evaluate the safety and efficacy of drugs or formulations. Specifically, Clinical Bioanalysis studies help evaluate the pharmacokinetic properties and bioavailability of drugs, metabolites, and prodrugs as well as run bioequivalence assessments for reformulations or generics. NorthEast BioLab is a premier Clinical CRO trusted by top biotech companies steering towards approval. Over the last 20+ years, our veteran team has delivered GLP/GCP Clinical Trial CRO services on 400+ studies. We provide reliable and actionable Clinical Bioanalysis CRO services for a streamlined path to drug development.

                                                            SPEAK TO OUR SCIENTISTS

                                                            What are Clinical Trials and associated CROs?

                                                            Clinical Trials CRO: Drug Safety and Efficacy in Humans

                                                            Clinical trials are research studies that are carried out to assess the effect of novel drugs or devices on the human body to prevent, cure, or manage various medical conditions. These trials evaluate the safety and efficacy of the medical treatment on the human body for the first time. Clinical trials are conducted in observance of strict protocols and guidelines to help gain valuable and actionable data for making informed decisions about the treatment under review.

                                                            Clinical trials are only initiated after the drug safety in animals has been clearly understood. That said, drug safety for humans is not guaranteed even as the drug toxicity in the animals has been evaluated. Therefore, clinical trials are typically initiated with a modest dosage of the drug to a small group of volunteers. Additional trials are then initiated following the results from these smaller trials.

                                                            Before the beginning of each clinical trial, a comprehensive protocol is drafted that includes the study objectives, design, scientific background, and statistical information. These protocols are the guardrails put together based on regulatory guidelines and contain at least following information –

                                                            • Study endpoints
                                                            • Length of the study
                                                            • Number of participants
                                                            • Eligibility criteria for patients or volunteers
                                                            • Drug dose and complete plan
                                                            • Clinical tests to monitor vital signs and ensure patient safety

                                                            Sponsors Love Our Bioanalytical Laboratory Services For Top Quality And Industry Leading Turnaround

                                                            Connect With Us For A Reference Call With Them!

                                                            User Vector
                                                            VP, Bioanalytical Development

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

                                                            User Vector
                                                            VP, Biomarker Development 

                                                            NorthEast BioLab is a responsive, collaborative, and reliable partner

                                                            User Vector
                                                            Executive Director, Pharmacokinetics

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

                                                            User Vector
                                                            President & CSO, Biotech

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

                                                            User Vector
                                                            Sr. Associate Dir., Clinical Trials

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

                                                            User Vector
                                                            Co-Founder, Biotech & University PI

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

                                                            User Vector
                                                            VP, PK PD Analysis

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

                                                            User Vector
                                                            Head, Bioanalytical Development

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

                                                            User Vector
                                                            Sr. Dir., Bioanalytical Development & QC

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

                                                            User Vector
                                                            SVP Quality & Compliance, Biotech

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

                                                            User Vector
                                                            Director, PK

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

                                                            User Vector
                                                            VP, Head of Clinical Operations

                                                            Our projects with NorthEast BioLab include successful method development, validation, stability studies during Clinical Phase I – IV studies.

                                                            User Vector
                                                            Executive Director, Drug Research

                                                            NorthEast BioLab provides critical insight, and are compliant with regulatory standards and industry best practices. We highly recommend them and look forward to working together again.

                                                            User Vector
                                                            Dir., Bioequivalence Testing

                                                            Our latest successful study was a pivotal bioequivalence study, where samples from a cross-over study with about 100 volunteers needed swift analysis.

                                                            User Vector
                                                            Head, PK

                                                            This study, same as all other bioanalytical studies, was completed with top quality and reporting standard with incredible responsiveness.

                                                            User Vector
                                                            VP, Development Operations

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

                                                            Tackle Your Clinical Trials Bioanalysis With Our Veteran Team Now!

                                                            SPEAK TO OUR SCIENTISTS

                                                            Which Clinical Bioanalysis CRO services do we offer?

                                                            Clinical Bioanalysis CRO services by NorthEast BioLab

                                                            NorthEast BioLab provides a range of clinical laboratory services from supplying the clinical kits for sample collection to pharmacokinetic, toxicokinetic, and biomarker bioanalysis, as well as long term storage of the biological samples. Our unified offering of these services enables the successful and seamless execution of your clinical trials.

                                                            Clinical Sample Collection Kits

                                                            Every sample collection kit assembled by your clinical research organization should comply with the specific requirements of the clinical trial protocol. At NorthEast BioLab we understand the advanced sampling needs of different clinical trials, and our sample kit contents are thoughtfully decided according to the following factors:

                                                            • Study type – Pharmacokinetic, Toxicokinetic, and Biomarker testing, etc.
                                                            • Study design – Number of volunteers, timepoints, duration, etc.
                                                            • Study matrices – Serum, plasma, whole blood, urine, stool, cerebral spinal fluid, tissue, etc.
                                                            • Sample /specimen volume collected
                                                            • Required stabilizing inhibitors or anticoagulants

                                                            Pharmacokinetic, Toxicokinetic, and Biomarker Bioanalysis

                                                            Our CRO services cover toxicokinetic, pharmacokinetic, and biomarker bioanalysis of samples collected during clinical trials.

                                                            • Pharmacokinetic testing of clinical trial samples by our scientists helps in assessing the effect of the human body on the drug under evaluation. This process analyses the absorption, distribution, metabolism, and excretion along with bioavailability of the drug compound.
                                                            • Toxicokinetic studies help understand the relationship between external drug exposure with target organ dosimetry as well as adverse effects. Generally, drug absorption, distribution, metabolism, and excretion at varying dose is closely monitored in these studies as well.
                                                            • Biomarker testing helps in evaluating the absolute and relative efficacy and safety profile of select drug candidates.

                                                            Long-term Clinical Sample Storage

                                                            Biological samples collected during a clinical trial must be appropriately stored and tracked for a full chain of custody until disposal. Regulatory agencies pay utmost attention to this to ensure that samples are stored in proper conditions to maintain the stability of the drug as this can impact the evaluation of the drug and provide erroneous results. At NorthEast BioLab, we can store and monitor biological samples under various conditions which range from 4C, -20C, -80C, and under liquid nitrogen. All our freezers are tracked 24/7 with multiple backup generators for an emergency.

                                                            Clinical Bioanalysis CRO services | NorthEast BioLab

                                                            Registered And Inspected By Various Regulatory Agencies

                                                            • Good Laboratory Practice for Nonclinical Laboratory Studies | NorthEast BioLab
                                                            • Food and Drug Administration (FDA | NorthEast BioLab
                                                            • clia
                                                            • United States Drug Enforcement Administration | NorthEast BioLab
                                                            • Department of Consumer Protection | NorthEast BioLab

                                                            Don’t Wait, Start Your Clinical Trials Bioanalysis Service Today!

                                                            SPEAK TO OUR SCIENTISTS
                                                            Clinical Trials CRO | NorthEast BioLab

                                                            Why choose us for your Clinical Trials CRO Services?

                                                            Outstanding Clinical Trials CRO to gain your Competitive Edge

                                                            NorthEast BioLab has 20+ years experience in helping sponsors accelerate their clinical trial timeline. We offer clinical laboratory services in strict compliance with regulatory guidelines to positively impact the intended purpose of your clinical trials. We are a clinical research organization that can manage and monitor your complicated clinical studies seamlessly, utilizing our bioanalysis and project management expertise, skilled scientists, technicians, and managers, as well as latest equipment and state-of-the facility. Thus, you can rely on NorthEast BioLab CRO services to advance your drugs with a shorter time to market, accurate efficacy and safety profile, and lower operational costs. Our team of expert scientists is eagerly looking to speak with you, whether you ended up here through a kind reference from one of our existing clients or through a regular Google search of clinical research organizations near me.

                                                            Drug Discovery and Development Process

                                                            How long do you think it takes for a new drug to get approved in the US? About 12-15 years, that’s roughly 1/3rd duration of the entire professional career for any of us. Next, how much investment do you think is required to bring a new drug…

                                                            Read More
                                                            Clinical video
                                                            Basics Of Bioanalysis | NorthEast BioLab
                                                            Clinical CRO Services Across Phase I-IV | NorthEast BioLab

                                                            What are the different phases in Clinical CRO services?

                                                            Clinical CRO Services Across Phase I-IV and beyond

                                                            Clinical trials for drug development span over four stages. These stages or clinical trial phases follow the advancement of a drug product through regulatory approval.

                                                            Phase I

                                                            Phase I of the clinical trial is executed with a small group – around 20-100 healthy individuals. Generally, the side-effects in this stage are minor as the human volunteers receive a low dose of the drug compound. Here, the drug intake is increased gradually to realize an optimal dosage while taking note of the side-effects. The study is designed to determine the treatment effects including the drug absorption, distribution, metabolism, and excretion.

                                                            Phase II

                                                            In this stage, the medical treatment is assessed on around 100 to 300 diseased patients for a few months to a couple of years. Most phase II studies are randomized and blinded, where the “control” group receives a standard treatment or placebo and the other set of patients receives the new drug. The aim of Phase II is to gather information about the relative safety and effectiveness of the drug.

                                                            Phase III

                                                            Phase III is an extension of phase II with a larger population (300 -3,000 or more individuals) to establish a thorough understanding of drug efficacy and safety, including the entire range of possible adverse reactions. Based on the success in this stage, the drug product is submitted to the FDA or other regulatory agencies for approval.

                                                            Phase IV

                                                            In Phase IV, the long-term effects of new drugs and treatments are identified and evaluated over an extended period. This phase is possible only once a new drug has the FDA approval and doctors can recommend it to patients.

                                                            Trust Our Clinical Trials Bioanalysis CRO Lab Services.

                                                            SPEAK TO OUR SCIENTISTS

                                                            Explore More Solutions

                                                            • Clinical Trials Bioanalysis CRO Lab Services | NorthEast BioLab Clinical CRO
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                                                            • GLP And Non-GLP Scientist For Preclinical Study Services | NorthEast BioLab Preclinical CRO
                                                            • Scientist For Method Development And Validation | NorthEast BioLab Method Development, Validation, And Transfer
                                                            • Scientist For Analytical Testing Laboratory Services | NorthEast BioLab Analytical Testing

                                                            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

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                                                            • Case Study
                                                            • Video Brochures
                                                            • News and Events
                                                            • Testimonials
                                                            • Contact Us
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                                                            • Good Laboratory Practice for Nonclinical Laboratory Studies | NorthEast BioLab
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                                                            • United States Drug Enforcement Administration | NorthEast BioLab
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