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Bioanalysis & Clinical Biomarker Support Services

Our purpose-built bioanalysis and clinical biomarker services help our partners readily detect and measure relevant biomarkers, understand drug performance, and provide clinical trial support. Particularly for companies lacking infrastructure and necessary equipment, partnering with a contract research organization (CRO) with expertise and experience in LC-MS bioanalysis and clinical biomarker services is critical to successfully bringing drug candidates to market.

We recognize, understand, and meet the need for a collaborative, trusted contract research organization (CRO) that offers comprehensive clinical biomarker services, including robust and sensitive bioanalysis and bioanalytical method development and validation to measure the activity and potency of drugs and therapies. Our team maintains both an up-to-date knowledge of the bioanalytics landscape and the advanced instrumentation required to skillfully conduct any bioanalysis request, from bioanalytical method development to clinical execution and everything in between. Our trusted team of experts understand what it takes to construct a method that clearly separates analytes of interest for accurate quantification in the full context of biological systems, informed by decades of experience in both analytical chemistry and biology. As a true partner, we can then act as your bioanalytical laboratory, performing data collection and analysis as needed, with fast turnaround times and a strong commitment to quality. Get a quote for bioanalysis today.

Clinical biomarker services

  • Fit-for-purpose single-plex and multi-plex custom assay development, validation, and transfer for novel therapies and biomarkers
  • Existing therapy and biomarker method transfers, including the transfer of bioanalytical methods to alternative platforms
  • Novel biomarker identification via nuclear magnetic resonance (NMR)
  • Enhancement and improvement of existing methods, including the determination of ppb/ppt limit of detection (LOD) and increased method sensitivity
  • Prompt and thorough clinical sample testing in a high throughput environment

    Biomarker and bioanalytical method development, validation, and transfer

    Our consultative team will collaborate with you to improve efficiency, robustness, sensitivity, selectivity, and ease of use of existing methods, in addition to identifying potential liabilities and de-risking regulated issues. Alternatively, custom methods and assays can be designed for well-known and obscure biomarkers alike. Methos are developed under the strict quality controls required by regulatory bodies (such as the FDA and EMEA) and standards, including ISO, GLP, and GMP guidelines. Given the high-stakes environment of clinical research and regulatory approval, quality control has been embedded into all clinical biomarker services, from beginning to end.

    Bioanalytical method validation also requires a detailed appreciation for the complexities associated with patient samples, such as diverse molecular composition and sample variations found across a cohort. Building upon past experience, our clinical biomarker services team circumvents challenges commonly associated with using a bioanalytical assay on patient samples, as they are adept at optimizing approaches for sample collection, stabilization, and extraction techniques for individual biological matrices, biomarkers, and drugs.

    We recognize the frustration associated with difficult method transfer processes. We take this essential task seriously, and consider effective method transfer as an essential component for making our work actionable, working diligently to ensure information is transferred properly for long-term success.

       

      High throughput bioanalysis

      We are committed to successfully meeting the needs of our customers by delivering accurate, high-quality results in a quick and efficient matter, enabled by our industry-leading, experienced teams of scientists and purpose-built labs. In addition to custom biomarker assay services and bioanalytical method validation, we can apply a previously established method, or one that has been developed by our industry-leading scientists, to execute sample analysis for both preclinical and clinical research.

      We understand that scientific teams sometimes do not have the bandwidth to manage an influx of sample bioanalysis, in addition to their existing responsibilities. To support your work without sacrificing precious time, our bioanalytical laboratory can act as an extension of your team, applying world-class expertise to analyze samples using the preferred bioanalytical method quickly and carefully.

      While our bioanalytical lab can use your existing methods or develop new ones to perform experimentation for a variety of drug and biomarker studies, you’ll also have access to off-the-shelf solutions for dosing formulation analysis, quantitative analysis of biomarkers and drugs in biological matrices, and interference testing, as well as toxicity and clearance. As a result, we can perform a number of analyses swiftly without sacrificing data quality, offering tremendous benefits in terms of accelerated turnaround times. Interested in knowing more? Let’s talk.

       

      Your Partner for Bioanalysis

      Bioanalysis and bioanalytical method validation are integral aspects of any preclinical and clinical research program. When done properly, bioanalytical method development empowers clinical research, precisely and accurately tracking drug levels in addition to patient response to therapy. In turn, clinical trials are fortified through the collection of data concentrating on the drug’s behavior and mechanism of action.

      When you partner with us for bioanalysis, you will have direct access to a collaborative team of highly skilled scientists and a suite of advanced analytical platforms including ddPCR and LC-MS bioanalysis, including Orbitrap QExactive and other systems. Our teams work tirelessly to ensure work is done efficiently, accurately, and to the highest performance and regulatory standards. Whether you are working with a well-established biomarker or a novel one, our biomarker services can support all aspects of bioanalytical method development and bioanalytical method validation, through to clinical trial support. For more information about our bioanalysis and clinical biomarker support services or to request a quote, contact us today.

      Unsurpassed Regulatory

      Given the sophistication of today’s pharmaceuticals and the complexity of the development process, an analytical lab partner with broad technical expertise and a strong regulatory history/performance is more important than ever. In a recent Industry Standard Research (ISR) survey, respondents noted technical expertise and regulatory history/performance as the most important criteria for selecting an analytical lab.

      Bioanalysis (Nonclinical and Clinical)

      Our laboratory uses a wide range of techniques and technology platforms to meet the needs of our customers, and more in support of PK/TK, pharmacology, bioequivalence and bioavailability studies, and biomarker assays from early discovery to post marketing. Bioanalysis is somewhat unique in that it is required for the evaluation of a therapeutic throughout the entire drug development cycle.

      Ready to Get Started?

      Give us a call and speak with an actual scientist.

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