Company

About

Musculoskeletal Clinical Regulatory Advisers

Musculoskeletal Clinical Regulatory Advisers

Manchester, Connecticut, United States

MCRA is the leading global full-service medical device, diagnostics, and biologics CRO and consulting advisory firm. MCRA delivers to its client's industry experience, integrating its seven business value creators: regulatory, clinical research, reimbursement, healthcare compliance, quality assurance, due diligence and distribution logistics to provide a dynamic, market-leading effort from innovation conception to commercialization. MCRA's integrated application of these key value-creating initiatives provides unparalleled value for its clients. MCRA has offices in Washington, DC, Hartford, CT, New York, NY, London, England, Winterthur, Switzerland, Eschborn, Germany and Tokyo, Japan and serves nearly 1,000 clients globally. Its core focus areas of therapeutic experience include orthopedics, spine, biologics, cardiovascular, diagnostic imaging, wound care, artificial intelligence, dental, anesthesia, general surgery, digital health, neurology, robotics, oncology, general and plastic surgery, urology, and in vitro diagnostic (IVD) devices and medical device cybersecurity. MCRA places particular emphasis on its expertise working with companies in all stages of development and throughout the technology life cycle by ushering technologies from the conceptual pre-clinical stage to market approval.

NorthEast BioLab

NorthEast BioLab

35 Worth Ave, Hamden, Connecticut 06518, US

With over 20 years of expertise, NorthEast BioAnalytical Laboratories LLC, also known as NorthEast BioLab, specializes in providing top-notch GLP and clinical bioanalytical services. We are proud to be trusted partners to hundreds of industry sponsors and renowned investigators in the biotechnology sector. We are an independent, full-service facility that adheres to GLP/GCLP compliance. Our FDA-audited and DEA & CT State Schedule II-IV approved facility is managed by Watson LIMS, ensuring seamless operations. Our dedicated scientists and project teams excel in assay development, optimization, troubleshooting, and full method validation on various platforms, including Ligand Binding Assays (ELISA, Meso Scale Discovery, Luminex, Western Blotting, etc.), Mass Spectrometry Liquid Chromatography (LC-MS/MS, HPLC-UV/DAD/Fluorescence, etc.), and Cell And Gene Therapy platforms (Cell-Based Assay, qPCR and dPCR). With our custom assay development services, we offer comprehensive solutions for pharmacokinetics analysis studies, toxicokinetic safety testing, immunogenicity assay, multiplex cytokine analysis, PD biomarker assessment, biochemical assay, mechanism of action, gene expression, copy number variation investigations, etc. Since its establishment in 2003, our team of dedicated biologists and chemists has been committed to empowering mission-driven biotech. With our vast experience and technical expertise, we deliver exceptional preclinical study and clinical assay development services as a Contract Research Organization (CRO). At NorthEast BioLab, we prioritize top quality and industry-leading turnaround time while offering highly competitive pricing. Our team is dedicated to helping you meet the stringent timelines of various milestones throughout your drug development life-cycle. SPEAK TO OUR SCIENTISTS today to expedite your bioanalytical assay development, validation, and sample analysis!

Phesi

Phesi

East Lyme, Connecticut, United States

Phesi has the industry’s most comprehensive and dynamic clinical trials database and predictive analytics tools to help trial sponsors make quick and informed decisions to expedite drug development. Our distinguished team works side-by-side with its clients to analyze data, answer questions, and offer informed solutions to benefit study sponsors, investigators, and ultimately patients. Phesi has been applying its innovative technology and deep expertise to help life sciences companies for over 10 years. Our experts work with study sponsors to drive solutions from clinical development planning through trial implementation to optimize protocol designs, select the best investigator sites, shorten enrollment cycle times, select and manage CROs, and much more.