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Tag Archives: drug development
Free Webinar – Optimal Clinical Study Designs and International Regulatory Strategies
Please join us at a joint webinar between the Netherlands Centre for Human Drug Development (CHDR) and Cato Research that addresses current challenges and provides clinical and regulatory strategies to the most expeditious and cost-effective path towards clinical proof of concept and approval. The webinar will be held on Tuesday, 15 November 2011 from 1:00 to 2:00 PM ET. Continue reading
Posted in Clinical Trials, Regulatory Strategy, Webinars
Tagged biomarkers, Cato Research, clinical trials, drug development, EMA, FDA, pharmacodynamics, pharmacokinetics, Phase 1, Phase 2, pivotal studies, regulatory strategy, webinar
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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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August 2011 FDA Guidances
Here’s a (very lengthy) list of the guidances released by FDA in August 2011, compiled by Cato Research Regulatory Scientist Cathy Anderson. Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring (Draft) Postmarket Surveillance Under Section 522 of the … Continue reading
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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