Element’s comprehensive bioanalytical testing services are dedicated to bringing industry-leading scientific expertise to help customers advance drug development programs by providing accurate and high-quality data.
A partnership with a strong, agile bioanalytical contract research organization (CRO) and contract development and manufacturing organization (CDMO) with a deep bench of scientific and regulatory expertise can help you successfully navigate the complexities of bioanalysis, ensuring therapies meet rigorous scientific and regulatory demands. Element’s bioanalytical laboratory is uniquely positioned to support challenging drug development projects, with an expert team and essential instrumentation.
As an experienced bioanalytical CRO, Element’s suite of bioanalytical testing services provide a broad range of bioanalyses to support clinical research. Importantly, biomarker validation and custom assay development are central components, tapping into our team’s experience and expertise in biomarker research and its clinical applications. We offer a full spectrum of bioanalytical testing services to support challenging drug development projects throughout the product development life cycle, from drug discovery and design to preclinical and clinical development through to filing, approval, and launch. Our expertise extends to biomarker validation, preclinical in vivo sample testing, as well as a complementary, complete offerings of drug metabolism and pharmacokinetics (DMPK) / adsorption, distribution, metabolism and excretion (ADME) services and toxicity assessments.
Bioanalytical testing services
Bioanalysis and clinical biomarker services – Element’s expert scientists can validate and improve existing methods or develop custom ones. We can also take these methods and use them to perform sample analysis, including quantitative analysis of biomarkers and drugs, applying leading knowledge of a diverse suite of biomarkers and multiple assay platforms.
DMPK and ADME support – Understanding how a drug behaves in a living system is critical for preclinical and clinical research as well as overall safety and efficacy. We offer advanced bioanalysis of a drug’s metabolic and pharmacokinetic profile including established and custom ADME assays and therapeutic drug monitoring. We can then use our method development and data collection abilities to fully support IND filing.
Toxicity and clearance assays – Complementing ADME investigations, clinical researchers need clear data on a drug’s toxicity. Element is adept at performing in vitro cytotoxicity assays to ISO-10993-5 standards and analyzing samples from preclinical toxicology studies. Together, we can help you determine dosing and reduce the risk of failure in later clinical trial phases. These residual and clearance assay skills can also be applied more broadly to support both drug and food safety.
Strong bioanalytical laboratory partnerships ensure patient safety
As we progress deeper into this new of age of medicine, revolutionary biologic therapies, personalized medicine, and other major advancements require more refined and thorough bioanalytics to evaluate efficacy and ensure patient safety. As the sophistication of biomedicine advances, so too do the demands and complexities of translational and clinical research. In particular, the growth of biomarker research opens up opportunities to track drug function more directly through its mechanism of action.
Collectively, this allows clinical research teams and regulators to make more informed decisions and increase the efficiency of the entire process. However, the knowledge required to adeptly execute on the potential of bioanalytics is often overwhelming and not easily acquired. This is particularly true given the ever-expanding list of relevant biomarkers across a range of biomolecular classes, as well as the many analytical platforms needed for biomarker analysis. Simply put, biopharmaceutical companies and drug developers have their work cut out for them.
Element’s purpose-built laboratories are equipped with essential instrumentation, and our consultative team of scientific experts stand ready to provide phase-appropriate bioanalytical laboratory support tailored to your specific needs, from custom method development to validation and sample analysis. Our team of dedicated experts recognize that adherence to regulatory guidance is critical to any drug development program and have an in-depth understanding of regulatory guidance and requirements, including Food and Drug Administration (FDA), European Medicines Agency (EMA), International Organization for Standardization (ISO), Good Laboratory Practices (GLP), and Good Manufacturing Practices (GMP). Whether you need help designing and developing, or simply need a trusted team to collect and analyze data, Element is the consultative, trusted bioanalytical CRO partner best equipped to meet your needs.
The Element advantage
Expedite the regulatory approval of your drug candidate with Element as your bioanalytical testing partner. With access to advanced equipment, a deep bench of scientific and regulatory expertise, and a commitment to flexibility and efficiency, you will benefit from quick turnaround times without sacrificing the highest quality standards. We can maximize study ROI with high integrity data, even when working with small sample volumes.
To discuss your research and how our bioanalytical testing services can make a difference, or to request a quote, contact us today.
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