What is a Preclinical Contract Research Organization (CRO)?

Preclinical CRO offers the necessary R&D expertise to navigate a drug candidate through animal testing and advance into the clinical phase. Preclinical CRO services include several Non-GLP and GLP studies critical to asses drug safety and efficacy in animal models for your Investigational New Drug (IND) filing. Successful completion of your IND package is the first milestone towards clinical drug development.

Numerous drugs get rejected during the preclinical studies due to subpar treatment effects or adverse outcomes such as toxicity. On top of that, your drug compound can be erroneously dismissed by the regulatory authorities if your preclinical CRO services aren't carried out correctly. Thus, it is necessary to find a preclinical CRO with a competent team that has both scientific expertise and regulatory awareness.

Before its market release, a drug must undergo a battery of testing to prove its safety and efficacy in humans. These clinical studies are only allowed following extensive preclinical studies under the supervision of certified biotech scientists and experts. This in-vivo testing must follow the ethics and regulations set for animal use in preclinical research. Afterward, the first in man study - including the first safe dose in phase I - is designed based on the data from preclinical studies.

What is the role of Preclinical Research in Drug Discovery and Development?

Preclinical research is a risk-assessment process to determine the drug impact on animals and extrapolate its possible outcome in humans. Preclinical studies, such as the toxicological and pharmacologic responses to the drug dosage, help advance the research with human volunteers.

During preclinical research studies, the bioanalytical sample collection must meet the standards of dose administration, animal treatment, and facility upkeep. The right preclinical CRO fulfills these expectations to not only avoid regulatory scrutiny but also expedite drug development. In our experience, the invaluable headstart from high-quality preclinical testing pays enormous dividends down the road.

Pharmacology

Pharmacology testing helps assess the pharmacodynamic (PD) and pharmacokinetic (PK) properties exhibited by a drug. Both these drug characteristics are essential in helping identify and measure the outcome of testing in animal models. PK properties help define ADME (absorption, distribution, metabolism, and excretion) features of a drug compound to further design experiments, studies, and trials as next steps.

Toxicology

The toxicological activity of the drug candidate first gets measured through in vitro and in vivo preclinical studies. While in vitro studies provides a direct impact on cell proliferation and phenotype, in vivo studies evaluate the drug toxicity by identifying effects on rodent and non-rodent animal species.

Throughout the preclinical testing phase, one crucial factor is the selection of relevant animal species and disease models. Pharmacological and toxicological preclinical studies in the correct animal species and models form the basis for drug testing in clinical trials.

Preclinical Research Services offered by NorthEast BioLab

Our preclinical research services cover complete bioanalysis of the drug candidates in-vitro and in-vivo and formulation analysis of test article in the vehicle. Generally, the in-vivo preclinical studies get initiated after the in-vitro studies are complete. These bioanalytical studies require sample analysis of drug and metabolites in a variety of biological fluids and tissues from different animal organs. Many of these analytical tests earlier in drug discovery and development can be completed using non-validated bioanalytical methods. However, the bioanalysis must be performed using a fully validated method when the drug advances into GLP Toxicity and Toxicology studies in multiple animal species. For example, the beginning of GLP repeat dose toxicity and toxicokinetic studies followed by Non-GLP dose range finding toxicity studies.

Method Development, Validation, and Transfer

Method development, validation, and transfer are processes to set-up and confirm whether the bioanalytical assay for drug analysis is suitable for its intended use. Adequate methods during in-vitro and in-vivo preclinical testing are essential for a straightforward transition of sample analysis from animal species to the clinical phase.

Mass Spectrometric and Chromatographic Bioanalysis

Bioanalysis quantitates drug, metabolites, and biomarkers in biological fluids such as plasma, serum, blood, and urine, etc. LC-MS/MS is commonly used for both the preclinical and clinical analysis as it has been established to provide significantly more reliable and reproducible results compared to other platforms.

ELISA based Assay

NorthEast BioLab offers various client-centric preclinical and clinical ELISA assay development services. We help you set-up the right ELISA assay and further optimize assay development and validation to ensure accurate and robust results.

Drug Stability Studies

It's essential to evaluate drug stability in plasma, blood, and any other biological fluids where the drug is analyzed. Incorrect data is generated if the drug is unstable in the examined matrix. This inaccurate data could affect drug development, even leading to drug failure at a later stage. Many techniques are available to stabilize and measure drugs accurately. At Northeast BioLab, we have worked on several such drugs and successfully stabilized and quantitated them during preclinical and clinical studies.

Why choose NorthEast Biolab for your Preclinical CRO Services?

NorthEast Biolab mitigates the risks of your drug development program by offering a holistic solution to your need of preclinical CRO services. We perform full bioanalysis at NorthEast BioLab and help outsource your cell culture, in-vivo, and pathology projects if requested. This approach helps our sponsors significantly accelerate their preclinical studies and reach the clinic faster. Our preclinical research services include bioanalysis, biomarker testing, as well as method development, validation, and transfer, etc.

Access to expert resources and 15+ years of experience enables us to provide an excellent in vitro, in vivo, and bioanalytical testing solution to our clients. NorthEast Biolab can help you navigate various testing requirements and regulatory hurdles, regardless of the current phase in which your drug development program. We understand that the introduction of life-changing therapies can change the lives of innumerable patients, and exist to help make your drugs reach the markets as quickly as possible.