Preclinical

Preclinical Research Services

To test Drug Safety and Efficacy, preclinical research in drug development is a risk-assessment process to know the impact of a drug on animals and extrapolate the possible outcome in humans. The preclinical studies, such as the toxicological and pharmacologic responses of the drug in relevance to the dose, assist in advancing the research with human volunteers.

For regulatory compliance with continuing the drug study, the sample collection and testing environment must be up to the specified standards of facility upkeep, treatment ethics, and safe dosage. The right preclinical CRO as we are, meet or exceed these expectations to support an accelerated clearing of this initial stage of drug development. Furthermore, the insights gained from the preclinical testing help with a streamlined drug development moving onwards.

Nonclinical Pharmacology

An integrated approach to GLP regulatory safety pharmacology and early non-GLP discovery pharmacology testing to help you progress from discovery through ICH. Explore testing specializations for in vitro & in vivo cardiovascular (CV) testing as well as neuroscience (CNS) respiratory and drug abuse liability assessments for your nonclinical studies.

-Abuse Liability & Substance Use Disorder Studies
-In Vitro & In Vivo CV Assessments
-Discovery (GLP & Non-GLP)
-Neurotoxicology Studies
-Infusion Studies
-ICH Core Battery Tests

Meet ICH Requirements & Lower Safety Endpoint Risks
You need to meet the regulatory requirements of the ICH core battery studies. But what about your own business risks? With many compounds, it’s possible to clear ICH hurdles only to face a host of safety endpoint issues as you advance from discovery, through early development and into clinical study phases. You need a value-added partner to help identify unsafe compounds earlier than ever before.
Access Endpoints During Toxicology Studies
By looking at safety pharmacology through a business risk lens, you begin to see the process of safety assessment in an entirely different light. Now you can economically assess your endpoints during your toxicology studies to make better safety predictions, earlier than ever before. With many compounds running into safety issues during the clinical phases, there is a great opportunity to anticipate these data in your nonclinical stage, saving you time and money long-term. By better understanding and reducing the risk of drug attrition of your molecule, you are able to progress forward with more confidence — and with the right molecules. Rethink what’s possible and gain a markedly different approach to your early safety assessment regimen.

Preclinical Testing

Determination of a drug’s safety profile is perhaps one of the most critical stages of the drug development pathway, and complications and inefficiencies at this late phase of the journey can create costly delays.

-IND Programs
-Toxicology
-Laboratory Sciences
-Safety Pharmacology
-Anatomic & Clinical Pathology
-Environmental Impact Assessment of Human Pharmaceuticals
-Drug Metabolism & Pharmacokinetics

Fetero is committed to providing exactly what clients need with flexible solutions, accelerated timelines and people who care about making a difference. Our experienced team helps clients to anticipate challenges, avoid roadblocks and expedite preclinical drug development with a wide array of safety assessment services and expert guidance through this important stage. Using state-of-the-art technologies in a global network of facilities, our skilled scientists execute individual studies and custom testing programs that are designed with a client’s goals in mind. Our regulatory experts ensure that all testing meets worldwide standards for quality and compliance, smoothing the path to market.