Clinical Trials Phase-I

We offer bioanalytical method development, validation, and sample analysis lab services for GCP Clinical Trials CRO.

We provide highly reliable clinical bioanalysis services with 500+ projects using LC-MS/MS, ELISA, MSD, Luminex, or qPCR.

We offer services -First-In-Human Clinical Trials CRO for NDA from preclinical IND testing.

What are clinical trials and the CROs that support them?

Clinical trials are research projects conducted to evaluate the impact of cutting-edge medications or medical equipment on the human body in an effort to treat, manage, or prevent various medical conditions. For the first time, these trials assess the safety and effectiveness of the medical treatment on the human body. Strict protocols and guidelines are followed during clinical trials in order to collect useful information that can be used to inform decision-making regarding the treatment being examined.

Clinical trials are only started once it is clear how safe a drug is for animals. Despite the fact that the drug toxicity in animals has been assessed, drug safety for humans is not assured. As a result, clinical trials are frequently started by giving a small number of volunteers a modest dosage of the drug. Following the outcomes of these smaller trials, new trials are then started.

A thorough protocol that details the study objectives, design, scientific context, and statistical data is created prior to the start of each clinical trial. These protocols, which serve as guardrails, were developed based on regulatory requirements and include at least the following details:

  • study’s objectives
  • Length of the study Participants’ numbers
  • eligibility requirements for volunteers or patients
  • drug dosage and overall strategy
  • clinical examinations to keep an eye on vital signs and guarantee patient security

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What are the various stages of Clinical CRO services?

Clinical CRO Services from Phase I through Phase IV and beyond

Drug development clinical trials have four stages. These stages, also known as clinical trial phases, come after a drug product advances through regulatory approval.

Phase I

The clinical trial’s Phase I is carried out with a small group of 20–100 healthy participants. Due to the low dose of the drug compound given to the human volunteers in this stage, the side effects are typically mild. Here, the dosage of the drug is gradually increased to achieve the ideal dosage while keeping track of any side effects. The goal of the study is to ascertain how treatments affect drug distribution, metabolism, and excretion as well as drug absorption.

Phase II

In this phase, the effectiveness of the medical intervention is evaluated over the course of a few months to a few years in 100 to 300 sick patients. Most phase II studies are randomized and blinded, with one group of patients receiving the new medication while the other group is given the standard of care or a placebo. Phase II’s objective is to gather data on the drug’s relative safety and efficacy.

Phase III

Phase III is an expansion of phase II, involving a larger population (300–3,000 people or more), with the goal of establishing a thorough understanding of drug efficacy and safety, including the full spectrum of potential adverse reactions. The drug product is submitted to the FDA or other regulatory agencies for approval based on the outcome of this stage.

Phase IV

Phase IV examines and assesses the long-term consequences of novel medications and therapies. Only after a new drug has received FDA approval and is able to be prescribed to patients is this phase feasible.

What CRO services do we provide for clinical bioanalysis?

We offer a variety of clinical laboratory services, including the provision of clinical collection kits, pharmacokinetic, toxicokinetic, and biomarker bioanalysis, as well as long-term preservation of biological samples. Your clinical trials can be carried out successfully and without any problems thanks to our comprehensive offering of these services.

Collection Kits for Clinical Samples

Your clinical research organization should adhere to the specific guidelines of the clinical trial protocol when assembling each sample collection kit. We at NorthEast BioLab are aware of the sophisticated sampling requirements of various clinical trials, and we carefully consider the following factors when selecting the components of our sample kits:

  • Pharmaceutical, toxicological, and biomarker analyses
  • Pharmacokinetic, toxicokinetic, and biomarker testing, among other study types.
  • Design of the study: Volunteers, timepoints, length, etc.
  • Serum, plasma, whole blood, urine, stools, cerebral spinal fluid, tissues, etc. are study matrices.
  • Volume of samples or specimens gathered

Anticoagulants or stabilizing inhibitors necessary

For samples obtained during clinical trials, our CRO services include toxicokinetic, pharmacokinetic, and biomarker bioanalysis.

  • Our scientists’ pharmacokinetic testing of clinical trial samples aids in determining how the human body reacts to the drug under consideration. This procedure examines the drug compound’s absorption, distribution, metabolism, excretion, and bioavailability.
  • The relationship between external drug exposure and target organ dosimetry as well as negative effects is better understood with the aid of toxicokinetic studies. These studies typically also closely monitor drug absorption, distribution, metabolism, and excretion at various doses.
  • The absolute and relative efficacy and safety profile of particular drug candidates are assessed using biomarker testing.

Long-Term Storage of Clinical Samples

A clinical trial’s biological samples must be properly stored and tracked throughout the entire chain of custody until disposal. The stability of the drug must be maintained when storing samples, so regulatory agencies pay close attention to this to prevent inaccurate results from being obtained when evaluating the drug. At NorthEast BioLab, we have the ability to monitor and store biological samples under a range of temperatures, including 4C, -20C, -80C, and liquid nitrogen. With numerous emergency backup generators, all of our freezers are monitored around the clock.

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