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Tag Archives: Phase 3
Recap of the 20th CED Biotech/Life Sciences Conference
The 20th Annual Council for Entrepreneurial Development (CED) Biotech/Life Science Conference was held on 21-22 February 2011 in Raleigh, North Carolina. Continue reading
Posted in Conferences and Meetings, Industry News, Venture Capital
Tagged biotech, capi, Cato BioVentures, Cato Research, clinical research, conference, development plan, drug development, funding, healthcare reform, Phase 2, Phase 3, venture capital
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When Should You Write your Statistical Analysis Plans?
Recently in the LinkedIn Biostatistics group, one user asked: A client wants me to prepare final SAP [statistical analysis plan] shortly after protocol and CRFs are finalized for a Phase 3 trial, to submit to FDA prior to start of … Continue reading
Posted in Clinical Trials, Statistics
Tagged biostatistics, case report form, CRF, enrollment, FDA, LinkedIn, methodology, Phase 3, protocol, SAP, statistical analysis
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Tips for your Special Protocol Assessment
A number of scientists with greatly different backgrounds can come up with completely different assessments. – Richard Leakey One question that we hear frequently is: Can we apply for a Special Protocol Assessment (SPA) for our Phase 3 trial? The … Continue reading
Posted in FDA
Tagged advisory committees, FDA, guidance, Phase 3, protocol, special protocol assesment
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