Top 10 Bioanalytical Services Companies - 2019
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Worldwide Clinical Trials: A CRO Experience Centered in Medicine and Science

Top 10 Bioanalytical Services Companies - 2019

The rising number of chronic diseases and their immense cost burden on healthcare systems is creating the need for personalized, innovative medicine and drugs in the market. This growing need for new drugs has resulted in an increase in R&D investment by biopharmaceutical companies. However, the pharma and biotech industries are under tremendous pressure to maintain consistent innovation in less time, using fewer resources than before. To that end, companies in these industries are looking for effective partners who can help them accelerate their journey toward new breakthroughs in drug development. With expert partners on their side, the pharma and biotech firms can use their internal resources for more value-added tasks and drive the business outcomes.

Aligning with the latest compliance regulations in the industry, bioanalytical services companies can serve pharma and biotech firms of all sizes in the areas of drug development at both preclinical and clinical stages. The pharma and biotech companies can outsource testing to efficient contract research organizations (CROs) to curtail operational expenditure costs and propel market growth over the forecast period. With in-depth knowledge of using cutting-edge analytical tools, the CROs can play a central role in the inspection, verification, testing of the various biomarkers and molecules. Using industry best practices and experience, the CROs can boost the confidence of the drug manufacturers in releasing their products to the market faster and maintain an edge in the market.

We hope this issue of Pharma Tech Outlook helps you build the partnership you and your firm need to enable technology-driven bioanalytical services.

We present to you Pharma Tech Outlook’s “Top 10 Bioanalytical Services Companies 2019.”

Top Bioanalytical Services Companies

Agilex Biolabs conduct bioanalysis of both small molecule and biologics using the established platforms of LC-MS/MS and immunoassay to support several studies from a global client base. AGILEX Biolabs has over 40 dedicated laboratory staff and more than 20 decades of experience in supporting preclinical and clinical programs. Their scientists have expertise in the development of robust, compliant PK and PD assays de novo or by method transfer from a client’s laboratory. Established in 1995, the company is headquartered in Thebarton, South Australia. The company offers Small Molecule, Large Molecule, LC-MS/MS Bioanalysis, Immunoassay Bioanalysis, clinical trials, and clinical research

www.agilexbiolabs.com

A Full-Service CRO delivering excellence in early stage clinical research, from Phase I & HAL trials to BE/BA studies. BioPharma comprehensive services also include Bioanalysis at GLP Certified Laboratory, Biostatistics and Safety Data Analysis (CDISC), scientific and regulatory affairs, medical writing, and data management. BioPharma has its headquarters in Toronto in a single facility where clinical and bioanalytical operations are housed under one roof. The company provides continued adherence to new guidances (FDA, CFDA, ICH M10, etc.) with its method validation approach, competitive market pricing without compromising on quality, as well as NDA programs for new-chemical entities (supporting both non-clinical and clinical study arms)

www.biopharmaservices.com

Neuro-Sys is a drug development and services company focused on neurodegenerative diseases. The company has developed specific pre-clinical models of neurological diseases to accurately determine the lead compounds’ pharmacological profiling and explore their underlying action mechanism. Using its dedicated researchers including best-in-breed physicians, neurologists, and scientists with pharma and biotech background, the company runs in-house R&D programs to identify and develop new compounds. Moreover, Neuro-Sys also holds expertise in the development of innovative models by leveraging its world-class, high-level scientists and high-end laboratory equipment. Additionally, as a part of its portfolio, the company offers fully automatic pharmacological platforms to screen in vitro and in vivo pre-clinical and pharmacological assays

neuro-sys.com

Founded by physicians committed to advancing medical science, Worldwide is out to change how the world experiences CROs – in the best possible way. From early phase and bioanalytical sciences through late phase, post-approval and real-world evidence, we provide world-class, full-service drug development services across a range of therapeutic areas, including central nervous system, cardiovascular, metabolic, general medicine, oncology and rare diseases. We never compromise on science or safety. We’re never satisfied with the status quo. We’re the Cure for the Common CRO

www.worldwide.com

BASi

BASi

BASi is a pharmaceutical development company providing contract research services and monitoring instruments to emerging pharmaceutical companies and the leading drug development companies and medical research organizations. The company focuses on developing innovative services supporting its clients’ discovery and development objectives for improved decision-making and accelerated goal attainment. Preclinical Tox, Early PK Studies, Bioanalytical Method Development & Sample Analysis, Culex In Vivo sampling system, stability storage, Microdialysis, UltraFiltration, pharmaceutical analysis, EC-LC analytical instruments, and generic drug development are some of the services offered by the business. BASi’s products focus on increasing efficiency, improving data, and reducing the cost of taking new drugs to market

Bioagilytix

Bioagilytix

BioAgilytix is a leading bioanalytical testing laboratory specializing in large molecule bioanalysis. With laboratory locations in North Carolina’s Research Triangle area and Hamburg, Germany, BioAgilytix provides PK, immunogenicity, biomarkers, and cell-based assay services supporting the development and release testing of biologics across a number of industries and disease states. The business offers assay development, validation, and sample analysis under non-GLP, GLP, and GCP, as well as GMP quality control testing (product release testing, stability testing). BioAgilytix’s team of highly experienced scientific and QA professionals ensures high-quality science, data integrity, and regulatory compliance through all phases of clinical development, and is a trusted partner to many of the top global pharmaceutical and biotech companies

Covance

Covance

Founded in 1987, Covance is a global contract research organization and drug development services company. The business provides early-and late-stage services to the pharmaceutical, biotechnology, and medical device industries. Its early-stage development services include preclinical and clinical pharmacology services. The company’s late-stage services include biomarker services to biotech and pharmaceutical customers, with full management of Phase II and III clinical studies. It also provides lab testing services to the chemical, agrochemical, and food industries. Because of their broad experience and specialized expertise, they are in a unique position to supply insights that go above and beyond testing. Covance has helped pharmaceutical and biotech companies develop each of the top 50 prescription drugs in the marketplace today

Frontage

Frontage

As a contract research organization, Frontage Laboratories provides integrated, science-driven product development services throughout the drug discovery and development process to enable pharmaceutical and biotechnology companies to achieve their development goals. Comprehensive services include drug metabolism and pharmacokinetics, analytical testing and formulation development, preclinical and clinical trial material manufacturing, bioanalysis, preclinical safety, and toxicology assessment, and early phase clinical studies. Frontage has enabled many biotechnology companies and leading pharmaceutical companies of varying sizes to advance a myriad of molecules through the development and file regulatory submissions in the United States, China, and other countries

NorthEast BioLab

NorthEast BioLab

NorthEast BioAnalytical Laboratories LLC (NorthEast BioLab) is a bioanalytical lab with 15+ years of experience in GLP and clinical bioanalysis services for drug testing and biomarker analysis to biotech and pharma companies, as well as the scientific and academic community across the healthcare sector. The business has extensive expertise in method development, validation, and transfer, mass spectrometric and chromatographic (LC-MS) bioanalysis, pharmacokinetics (PK) sample analysis, toxicokinetic safety testing, as well as other custom assay services. NorthEast’s assay services include ELISA based assay, cell-based assay, biomarker testing, immunogenicity testing, biochemical assay, and Mechanism of Action (MoA) studies

PPD

PPD

Headquartered in Wilmington, North Carolina, PPD is one of the best global contract research organization providing comprehensive, integrated drug development, laboratory, and lifecycle management services. With offices in 46 countries and approximately 23,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development and optimize value in delivering life-changing therapies to improve health. Their clients benefit from comprehensive lab services spanning bioanalytical, biomarkers, central lab, GMP, and vaccine sciences. Their laboratory services accelerate pharmaceutical development for small molecules and biologics