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Tag Archives: nonclinical research
Project Management for Biotech Companies
In today’s fast paced, high pressure world of drug development there are multiple factors that can and do affect marketing success. Large organizations understand the value that project management can contribute to a successful project. The smaller companies tend to … Continue reading
Posted in Clinical Trials, Project Management, Regulatory Strategy
Tagged biotech, Cato Research, central labs, clinical investigator, clinical research, clinical trials, CMC, CROs, drug development, drug product, efficacy, enrollment, FDA, GCP, GLP, GMP, ICH, manufacturing, nonclinical research, project management, protocol, safety, site selection, SOP, stability, toxicology
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Biotech Funding: Still Playing Hard-to-Get
After a few lean years, biotechs raised $25 billion in 2010. For the majority of small companies however, funding remains difficult to find. Ernst & Young’s annual report on the biotechnology industry, Beyond Borders, was recently released and it paints … Continue reading
Posted in Clinical Trials, Industry News, Venture Capital
Tagged biotech, Cato BioVentures, clinical research, clinical trials, drug development, funding, nonclinical research, Orphan Drug Designations, R&D
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Conference Recap – 2011 Society of Toxicology Annual Meeting
The Society of Toxicology’s (SOT) 50th Anniversary Annual Meeting was held on 05-10 March 2011 in Washington, DC. Several members of Cato Research’s Nonclinical Sciences Development group were amongst the more than 7,000 toxicologists from 50 countries in attendance this … Continue reading
Posted in Conferences and Meetings
Tagged FDA, Margaret Hamburg, NIH, nonclinical research, preclinical, safety, toxicology
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Vendor Selection – All that Glitters is Not Gold
One of the most important, and difficult, decisions a company has to make is selecting the right contract research organization (CRO) for outsourcing its nonclinical, manufacturing, clinical and regulatory activities. Several variables determine what makes a good outsourcing partner – … Continue reading
Posted in Clinical Trials, Regulatory Strategy
Tagged biotech, clinical trials, CMC, CROs, drug development, funding, IND, manufacturing, nonclinical research, outsourcing, pre-IND, regulatory affairs
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