Element recognizes, understands, and meets the need for a collaborative, trusted contract research organization (CRO) and contract development and manufacturing organization (CDMO) that offers comprehensive clinical biomarker services, including the development and validation of robust and sensitive bioanalysis and bioanalytical methods to measure the activity and potency of drugs and therapies.
Preclinical research programs rely on the careful measurement of key biomarkers in clinical samples to determine safety and efficacy, as well as to assess clinical outcomes. Particularly for companies lacking infrastructure and necessary equipment, partnering with a CRO/CDMO with expertise and experience in LC-MS bioanalysis and clinical biomarker services is critical to successfully bringing drug candidates to market.
In addition to the scientific expertise and in-depth understanding of regulatory guidance that Element brings, our trusted team of experts can help drug developers identify, optimize, and execute the optimal approach to meet their clinical bioanalysis needs.
Element is committed to successfully meeting the needs of our customers by delivering accurate, high-quality results in a swift and efficient matter, enabled by our industry-leading, experienced Ph.D.-led teams of scientists and purpose-built labs.
Biomarker & bioanalytical method development and validation 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
The Element advantage
When you partner with Element 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.
For more information about our bioanalysis and clinical biomarker support services or to request a quote, contact us today.
Nearly 190 Years of Making Certain
More from Element
Element’s comprehensive bioanalytical testing services are dedicated to bringing industry-leading scientific expertise to help customers advance drug development programs.
DMPK & ADME Services
Element offers a wide range of ADME and DMPK laboratory services, and we can accept both in vivo and in vitro samples.
Clearance Assays & Toxicity Testing
Element offers comprehensive, independent assessments of drug in vitro cytotoxicity and preclinical toxicology in addition to a well-developed collection of residual and clearance assays to confirm molecular clearance in animal-derived, complex matrices, including food.
Biopharmaceuticals and Biologics Analysis
Element’s significant expertise in all stages of biologics R&D, from in-house protein biochemistry and molecular biology to cellular biology and QC experience, supports the entire product development life cycle.