--- title: CROs offering Biomarker Assays with Gene Therapy path: /explore/biomarker-assays/gene-therapy companies_count: 24 --- # CROs offering Biomarker Assays with Gene Therapy 24 published CROs match Biomarker Assays and Gene Therapy. Locations in this set include United States, China, India, Netherlands, United Kingdom, and Belgium. Capabilities that show up most often in this set: Bioanalysis, Ligand-Binding Bioanalysis (Large Molecule), Immunogenicity Assays (ADA / NAb), Regulatory Affairs, and Translational Research. ## Matching companies - [Accelevir](/companies/accelevirdx) - CLIA-certified CRO specializing in ultra-sensitive molecular analytics, custom immunology assays, and integrated virology-immunology workflows for cell therapies, gene editing, and infectious disease programs. - [Amador Bioscience](/companies/amadorbioscience) - Amador Bioscience provides bioanalysis and biomarker services, including LCMS, immunoassays, flow cytometry, and immunogenicity testing, alongside clinical pharmacology modeling and regulatory affairs support. Its labs are GLP compliant, and its teams work across the US, China, and Europe. - [Aragen Life Sciences](/companies/aragen) - Global CRDMO partner offering integrated discovery-to-commercialization services across small molecules and biologics, with 4000+ scientists and R&D/manufacturing campuses in Asia, North America, and Europe. - [Celerion](/companies/celerion) - Global CRO specializing in early-phase clinical research and bioanalytical sciences with 650+ beds across 30 countries and 50+ years of experience. - [Certara](/companies/certara) - Certara transforms drug development with proprietary biosimulation software, predictive modeling, and AI-driven services spanning discovery through commercialization. Serving 2,400+ biopharmaceutical companies and regulatory agencies across 70 countries, Certara's model-informed drug development (MIDD) platform accelerates clinical and regulatory decision-making. - [Crown Bioscience](/companies/crownbio) - Preclinical oncology CRO offering 2,500+ PDX models, organoid and cell line databases, and translational platforms with biomarker discovery and AI-driven systems biology for drug development. - [Frontage Laboratories](/companies/frontagelab) - Global pharmaceutical development organization offering integrated drug discovery, preclinical safety/toxicology, DMPK, bioanalytical, and clinical trial services across 28 sites with 2,200 employees and 200+ FDA inspections. - [ICON plc](/companies/iconplc) - ICON is a global clinical research organization providing full-service drug development and clinical trial solutions across early phase through post-marketing, including clinical operations, bioanalytical labs, cardiac safety, medical imaging, and regulatory affairs. - [IQVIA](/companies/iqvia) - IQVIA is a global life sciences and healthcare company providing data, expertise, AI, analytics, and technology solutions to support clinical development and improve patient outcomes. - [InnoSer Laboratories](/companies/innoserlaboratories) - Preclinical CRO offering GLP and non-GLP toxicology, custom genetically modified mouse models, and disease models across oncology, neurology, immunology, metabolic, and cardiovascular research. Supports programs from target discovery through IND-enabling studies. - [Labcorp](/companies/labcorp) - Labcorp is a global life sciences and healthcare company providing diagnostic testing, drug development, nonclinical research, central laboratory services, and real-world data solutions to healthcare providers, health systems, and biopharma companies. - [Medpace](/companies/medpace) - Full-service CRO with 30+ years of organic growth, offering integrated clinical development services across all phases with wholly-owned central labs, bioanalytical lab, imaging core lab, and Phase I unit. - [NorthEast BioLab](/companies/nebiolab) - Bioanalytical CRO providing PK/PD, immunogenicity (ADA/nAb), cytokine, and biomarker assays across LC-MS, Meso Scale Discovery, ELISA, and ddPCR platforms. Operates GLP/GCLP-compliant facilities and reports DEA and CT approval for Schedule I–IV bioanalysis. - [PPD](/companies/ppd) - PPD is a leading global contract research organization (CRO) and the clinical research business of Thermo Fisher Scientific. - [Parexel](/companies/parexel) - Parexel is a comprehensive CRO offering end-to-end biopharmaceutical development services spanning portfolio optimization, early development, integrated clinical development, regulatory approval, and lifecycle value substantiation. - [Pharmaron](/companies/pharmaron) - Premier life science CRO and CDMO offering integrated R&D and manufacturing across drug discovery, preclinical, clinical development, and commercialization for small molecules, biologics, and cell & gene therapies. 25,000+ employees across China, US, and UK. - [QIAGEN Discovery Sciences](/companies/qiagen) - QIAGEN Discovery Sciences delivers genomics, bioinformatics, and molecular analysis solutions spanning research discovery through clinical diagnostics, with expertise in nucleic acid extraction, digital PCR, NGS workflows, and omics data interpretation. - [QPS](/companies/qps) - QPS provides integrated contract research and clinical services spanning bioanalysis, preclinical development, and early-to-late phase clinical trials across multiple therapeutic areas including oncology, dermatology, and women's health. - [Sannova](/companies/sannova) - Sannova provides bioanalytical and analytical CRO services, including immunogenicity and ligand binding assays, PK testing, DMPK services, extractables and leachables, nitrosamine testing, and pharmaceutical stability testing. Its listed work spans small molecules, biologics and biosimilars, and cell and gene therapies. - [Swiss BioQuant AG](/companies/swissbioquant) - Bioanalytical CRO offering LC-MS/MS and ligand-binding assay development, validation, and sample analysis for small and large molecules. Work runs in a 21 CFR Part 11 compliant environment, with qPCR support for gene therapy bioanalysis.