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

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.

Clinical Bioanalysis CRO services by NorthEast BioLab

boutique Contract Research Organization

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.

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…

Outstanding Clinical Trials CRO to gain your Competitive Edge

NorthEast BioLab has 15+ 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.

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