NCBiotech Company Directory

A comprehensive listing of North Carolina's life science industry

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Showing 1 - 50 of 54 results found.

Activity Company Description Location
Company Adaptive Plus LLC Activity: Support and Related Support and Related Company Description Adaptive Plus offers offers development of most types of adaptive clinical trial designs including Phase II-III designs with adaptive treatment selection, and unblinded sample size re-assessment. Location Durham
Company ADS Pharma Consulting LLC Activity: Support and Related Support and Related Company Description ADS provides drug development consulting services, including active pharmaceutical ingredient route development and manufacturing, analytics, formulation development, clinical batch manufacture and CMC regulatory affairs. Location Apex
Company Amanda Grim's GCP Audits LLC Activity: Support and Related Support and Related Company Description Amanda Grim's GCP Audits provides clinical QA consulting and auditing services related to risk-based quality strategies, audits, training, SOP development and gap analyses. Location Carolina Beach
Company Anixis Biomedical Consulting LLC Activity: Support and Related Support and Related Company Description Anixis offers business, regulatory and drug development consulting services. Expertise includes business plan and technology assessment, preclinical and clinical drug development, clinical trial protocols, regulatory interactions and writing. Location Durham
Company Apex Biostatistics Inc. Activity: Support and Related Support and Related Company Description Apex Biostatistics provides biostatistics, SAS programming, data management, data modeling and data analysis services to the pharmaceutical industry. Location New Hill
Company Array BioStatistics LLC Activity: Support and Related Support and Related Company Description Array BioStatistics provides statistical programming, clinical study design, regulatory support and data monitoring for phase I-IV trials. Location Wilmington
Company Biometrical Solutions LLC Activity: Support and Related Support and Related Company Description Biometrical Solutions is a statistics and statistical programming consulting company with global CRO and pharmaceutical experience in clinical drug development study design, analysis and NDA submissions. Location Raleigh
Company Biostudy Solutions LLC Activity: Support and Related Support and Related Company Description Biostudy Solutions provides pharmacokinetic and statistical services to the pharmaceutical industry. Services include clinical study design, in-vivo and in-vitro analyses, including those for EMD and IVPT, and sample size calculations for BA/BE. Location Wilmington
Company Blue Water Technical Services LLC Activity: Support and Related Support and Related Company Description Blue Water Technical Services provides contract validation, quality assurance, compliance and auditing (GMP and GLP) services to the FDA regulated industries (pharmaceutical, medical device, biotechnology, clinical trials, food processing, etc.). Location Farmville
Company Bogier Clinical & IT Solutions Inc. Activity: Support and Related Support and Related Company Description BOGIER connects employers and job seekers in the Clinical/IT industries and provides clients with SAS Programmers. Location Raleigh
Company Calvert Research LLC Activity: Support and Related Support and Related Company Description Calvert is a network of partners who assist companies with drug discovery, IND consulting, NDA submission, business development, preclinical studies, phase I and Phase II studies, capital investment, staffing and management. Location Cary
Company Carolina Research and Consulting Services Inc. Activity: Support and Related Support and Related Company Description Carolina Research and Consulting Services conducts early phase pharmaceutical, biologicals and medical device development, focusing on oncology, transplant and infectious diseases. Location Midland
Company Carolina Research Group Inc. Activity: Support and Related Support and Related Company Description Carolina Research group provides services in regulatory affairs, clinical research and general product development. Location Raleigh
Company Catalyst Biopharma Services LLC Activity: Support and Related Support and Related Company Description Catalyst Biopharma Services provides consulting services for clinical trial project management and clinical operations activities. Location Cary
Company Catalyst Clinical Research LLC Activity: Support and Related Support and Related Company Description Catalyst is a clinical development organization providing global resourcing solutions, functional and full-service managed solutions, the latter with a focus on oncology therapeutics, to the global biopharmaceutical industry. Location Durham
Company Catalyst Clinical Research LLC (Raleigh) Activity: Support and Related Support and Related Company Description Catalyst is a clinical development organization providing global resourcing solutions, functional and full-service managed solutions, the latter with a focus on oncology therapeutics, to the global biopharmaceutical industry. Location Raleigh
Company Certara Activity: Support and Related Support and Related Company Description Certara provides modeling and simulation, regulatory science, and scientific value assessment software and services to aid in drug development. Location Raleigh
Company Clinical Pathways Inc. Activity: Support and Related Support and Related Company Description Clinical Pathways provides consulting services to medical device and in vitro diagnostic product manufacturers with U.S. and international regulatory, clinical, technical, and quality system requirements. Location Raleigh
Company Clinical Pharma Specialist Consultants LLC Activity: Support and Related Support and Related Company Description Clinical Pharma Specialist Consultants provide consulting advice for clinical trial design, pharmaceutical development, safety monitoring and regulatory approaches, with a specialization in the respiratory therapeutic areas. Location Raleigh
Company Clinical Pharmacology Consulting LLC Activity: Support and Related Support and Related Company Description Clinical Pharmacology Consulting provides consulting services for drug development, medical and medical-legal issues. Location Durham
Company Clinology LLC Activity: Support and Related Support and Related Company Description Clinology offers drug development consulting services, including biopharma clinical development planning, CRO proposal strategy, CRO and vendor selection and oversight, and infrastructure planning. Location Apex
Company Cornerstone Pharma Consulting LLC Activity: Support and Related Support and Related Company Description Cornerstone Pharma Consulting provides formulation development, clinical trial supplies manufacturing and packaging, process optimization, formulation/process trouble shooting and scale-up consulting services. Location Raleigh
Company CROS NT LLC Activity: Support and Related Support and Related Company Description CROS NT provides biostatistics methodology, programming and analysis, clinical data management, medical writing, pharmacovigilance and clinical technologies (EDC, ePRO, IWRS, CTMS) for Phase I-IV drug development trials and medical device studies. Location Chapel Hill
Company D.P. Ward, MD, Drug Development Consulting Inc. Activity: Support and Related Support and Related Company Description D.P. Ward, MD, Drug Development Consulting provides Phase I-III drug development and regulatory consulting and due diligence. Location High Point
Company DFS Pharma Activity: Support and Related Support and Related Company Description DFS Pharma provides database solutions and data management services for early phase, late phase, medical device, investigator-sponsored trials, and veterinary science clinical studies. Location Wilmington
Company Drug Safety Navigator LLC Activity: Support and Related Support and Related Company Description Drug Safety Navigator provides safety and pharmacovigilance consulting to small to mid-sized pharmaceutical and biotech companies. Services include adverse event case management, benefit-risk assessment, PV training, medical writing and signal detection. Location Durham
Company Edgerton Data Consulting LLC Activity: Support and Related Support and Related Company Description Edgerton Data Consulting assists pharmaceutical, biotech and medical device companies with CRO selection and oversight to ensure data management, biostatistics, and CDISC deliverables are timely, complete, and accurate. Location Chapel Hill
Company EpiPointe LLC Activity: Support and Related Support and Related Company Description EpiPointe uses epidemiologic methods to develop and implement observational and experimental studies to combat infectious diseases globally. Location Cary
Company FDA Quality and Regulatory Consultants LLC Activity: Support and Related Support and Related Company Description FDA Quality and Regulatory Consultants offers specialized quality, regulatory and validation consulting for pharmaceutical, medical device and biotech companies. Location Raleigh
Company Field Clinical Solutions Inc. Activity: Support and Related Support and Related Company Description Field Clinical Solutions provides field clinical support for medical device trials, including field operations, enrollment support, trial compliance and technical support for investigational devices. Location Cary
Company Inpernum Pharma Solutions LLC Activity: Support and Related Support and Related Company Description Inpernum provides strategic biopharmaceutical support across pre-IND activities, regulatory filings, communications and submissions, clinical development strategies, and CMC/Quality activities for emerging biopharma companies. Location Raleigh
Company Matheus BD Connections LLC Activity: Support and Related Support and Related Company Description Matheus BD Connections provides business development, sales and marketing services for niche clinical research industry providers. Location Wilmington
Company Myer PharmTox Consulting LLC Activity: Support and Related Support and Related Company Description Myer PharmTox Consulting offers nonclinical toxicological consulting to pharma clients. Services include nonclinical development plan formulation, CRO laboratory selection, site monitoring, data analysis and communication with regulatory agencies. Location Cary
Company Nuventra Pharma Sciences Inc. Activity: Support and Related Support and Related Company Description Nuventra Pharma Sciences is a clinical pharmacology consulting firm specializing in pharmacokinetics and pharmacometrics. Nuventra also provides regulatory, writing and strategy support for nonclinical and clinical development plans. Location Research Triangle Park
Company Oceania Clinical Group LLC Activity: Support and Related Support and Related Company Description Oceania Clinical Group provides clinical research consulting services such as clinical development strategy for Phase I-IV programs, CRO management and oversight, evaluation of in-license opportunities and QA site audits. Location Wilmington
Company OD Consulting and Neurological Services PLLC Activity: Support and Related Support and Related Company Description OD Consulting and Neurological Services provides consulting in the areas of clinical development, safety monitoring and regulatory submissions of CNS-focused drugs and devices, and healthcare training and clinical services. Location Chapel Hill
Company OmniComm Systems Inc. Activity: Support and Related Support and Related Company Description OmniComm Systems provides eClinical software solutions to manage risks and enhance compliance. OmniComm Systems serves the biopharma, CRO, diagnostic and device markets, as well as academic medical centers. Location Raleigh
Company OrthoCarolina Research Institute Inc. Activity: Support and Related Support and Related Company Description OCRI was founded to advance and improve orthopedic healthcare and foster scientific collaborations between OCRI, universities, hospitals, pharmaceutical companies, healthcare device manufacturers and other academic and research organizations. Location Charlotte
Company OrthoKinetic Technologies LLC Activity: Support and Related Support and Related Company Description OrthoKinetic Technologies is a medical device testing and regulatory consulting firm with a subsidiary ISO certified test facility. The company provides a turnkey approach for assessing medical device performance and safety. Location Southport
Company PATH Clinical Development Services LLC Activity: Support and Related Support and Related Company Description PATH Clinical Development Services provides medical writing, regulatory document preparation, clinical development strategy and clinical operations solutions. Location Chapel Hill
Company Paw Pharma Services LLC Activity: Support and Related Support and Related Company Description Paw Pharma Services provides formulation, development, technical transfer, clinical trial logistics and program management consulting services. The firm provides oversight for manufacturing and clinical trials and manages outsourcing activities. Location Cary
Company Personalized Medicine Partners LLC Activity: Support and Related Support and Related Company Description Personalized Medicine Partners faciltates the translation of science into products and platforms for clinical development, enabling commercialization of novel treatments and laboratory tests, with a focus in the field of precision medicine. Location Raleigh
Company PharPoint Research Inc. (Wilmington) Activity: Support and Related Support and Related Company Description PharPoint Research provides clinical monitoring, data management, biostatistics and consulting services for Phase I-IV clinical trials. Location Wilmington
Company PharStat Inc. Activity: Support and Related Support and Related Company Description Pharstat provides biostatistics, clinical pharmacokinetics and statistical programming services to pharmaceutical and biotech companies. Location Raleigh
Company Preclinical Pathfinder Systems Activity: Support and Related Support and Related Company Description Preclinical Pathfinder is a CRO providing preclinical study design and execution partnering with Duke and other universities. Expertise includes animal imaging, surgical models, phamacokinetics (PK), Phase I/translation and advanced model development. Location Durham
Company SLSOncology LLC Activity: Support and Related Support and Related Company Description SLSOncology provides drug development and clinical strategy consulting for pharma and biotech start-ups in oncology, hematology and immunology. Services include IND and NDA filings. Location Durham
Company Social & Scientific Systems Inc. Activity: Support and Related Support and Related Company Description Social & Scientific Systems provides technical biomedical research and IT support, project and program management services in the areas of clinical, epidemiologic, and public health studies, health data management, program evaluation and policy analysis. Location Durham
Company Spector Consulting Services Activity: Support and Related Support and Related Company Description Spector Consulting Services provides consulting in preclinical and clinical drug research, and medical writing. Dr. Spector also serves as an expert witness. Location Durham
Company Statogen Consulting Activity: Support and Related Support and Related Company Description Statogen Consulting is a biostatistics consulting company specializing in advanced pharmaceutical design and analysis of clinical trials. Location Wake Forest
Company Tau Clinical Research LLC Activity: Support and Related Support and Related Company Description Tau Clinical Research provides monitoring services for clinical trials as well as training for clinical research associates. Location Greenville