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Safety pharmacology

An integrated approach to early discovery pharmacology and GLP regulatory safety pharmacology testing to help you progress from discovery through IND/CTA.
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Pharmacology capabilities to support your GLP safety endpoints

One of the biggest challenges pharmaceutical companies face is ensuring that their drug candidates are both safe and effective. Unforeseen adverse effects can lead to costly late-stage failures, regulatory setbacks and potential harm to patients. How can you meet regulatory requirements for ICH core battery studies while minimizing these risks and optimizing your chances of success? You need a value-added partner to help identify unsafe compounds earlier than ever before.

Why choose Labcorp?

  • Streamline  progress from discovery through IND and beyond with integrated, multidisciplinary insights

  • Meet new ICH E14/S7B Q&As compliance for in vitro hERG and in vivo cardiovascular telemetry studies

  • Consistent and integrated study data, interpretation and reporting through globally harmonized and centralized platforms

Meet ICH requirements & lower safety endpoint risks  

Our integrated, multidisciplinary approach streamlines your progress from discovery through IND and beyond, saving you time and money long-term. We offer a range of services to assess the potential adverse effects of your drug candidates on vital physiological functions. Our team works as an extension of yours to:

Maintain compliance with new ICH E14/S7B Q&As for in vitro hERG and in vivo cardiovascular telemetry studies

Provide consistent data interpretation and study conduct with harmonized nonclinical ECG analysis

Enable seamless integration of study data and reports across technologies with our data-handling platform

Pharmacology capabilities

Access endpoints during toxicology studies

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 this data in your nonclinical stage.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.

ICH E14/S7B Q&A Guideline: Remove clinical TQT burden with high-quality double-negative preclinical data

With the  ICH E14/S7B Q&As,  preclinical in vitro and ECG data can now be used to impact clinical ECG study design. Compounds that are deemed a low risk based on preclinical data (hERG and in vivo QT) allow sponsors more options to substitute the human thorough QT (TQT) trial with Phase 1 ECG data by leveraging preclinical in vitro hERG and in vivo QTc data, reducing the overall industry TQT burden for low-risk compounds. In addition to establishing hERG Q&A capabilities, we have in place all the new quality standards for ECG Telemetry that demonstrate achievement of QTc sensitivity equivalent to that of the clinic. Moreover, we have been at the forefront of numerous Q&A industry groups giving presentations and leading client discussions on this topic. Let us  guide you on how to best apply the new guidance to your drug development portfolio.

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Explore discovery pharmacology options earlier

Address liabilities pertaining to both cardiovascular and non-cardiovascular — targeted drugs, earlier than ever before. “Frontloading” your program is a process where you address cardiovascular or seizure liability safety endpoints prior to the selection of your drug candidate.

Although not mandated by the key regulatory guidance for safety pharmacology, an increasing number of companies choose to conduct early non-GLP safety studies in support of decisions on the progression of their compounds. These studies can be incorporated in lead optimization toxicology programs or integrated with mechanistic endpoints.

Start your discovery efficacy and early safety respiratory studies right with lead optimization in vivo and in vitro models.

EEG
Scientist looking into a microscope. The camera is pointing directly at the scientist

Expert pathology insights to support confident safety decisions

Pathologists play a vital role in understanding how a drug, compound, device or vaccine affects biological systems. In toxicologic pathology, their expertise goes beyond diagnosing changes; they help uncover the underlying mechanisms of toxicity, evaluate safety signals and assess risk versus benefit.

By identifying and characterizing tissue- or organ-level effects, pathologists provide the critical insights needed to guide development decisions, support regulatory submissions and protect patient safety.

Get the toxicology insights you need to move forward with confidence

When you're evaluating the safety of your compound, you need toxicology studies that are tailored to your program—regardless of species, route of administration or therapeutic modality. Our comprehensive toxicology solutions are designed to meet those needs, whether you're in early discovery or preparing for regulatory submission.

Chemist working in industrial laboratory
Shot of a young scientist working with medical samples in a lab

Innovative in vitro and NAMs solutions for ethical, efficient drug development

Advance your program with next-generation tools that reduce reliance on animal testing while delivering high-quality, human-relevant data. Our New Approach Methods (NAMs) and in vitro alternatives support ethical, sustainable development without compromising scientific rigor. From mechanistic assays to high-throughput screening and organ-on-a-chip technologies, these solutions help you assess safety, efficacy and toxicity earlier in the pipeline, streamlining decision-making, reducing costs and supporting regulatory acceptance.

Frequently asked questions

The core battery of safety pharmacology studies typically includes cardiovascular, respiratory and central nervous system assessments. Labcorp offers comprehensive testing for all these areas, as well as additional studies tailored to specific drug candidates and regulatory requirements.

Safety pharmacology studies are usually conducted before first-in-human trials but can start as early as discovery. Labcorp can work with you to design and implement studies at the appropriate stage of your development program, ensuring timely data for regulatory submissions.

Integrating safety pharmacology endpoints into toxicology studies can provide valuable data while potentially reducing animal use. Labcorp offers expertise in designing integrated studies that meet both safety pharmacology and toxicology objectives efficiently.

Labcorp utilizes state-of-the-art technologies such as telemetry systems for cardiovascular assessments, plethysmography for respiratory studies, JET/RIP for large animals and automated behavioral analysis systems for CNS evaluations.

Yes, our team of experienced scientists can provide expert interpretation of study results, including their potential impact on your development program. We offer comprehensive reporting and can assist in developing risk mitigation strategies if needed.

From early discovery to regulatory submission and beyond, our nonclinical development solutions help derisk your program, accelerate timelines and optimize decision-making.