Tag Archives: Phase 3

Conference Recap – 2011 ACRP Global Conference and Exhibition

The 2011 Association of Clinical Research Professionals (ACRP) Global Conference and Exhibition was held on 30 April – 03 May 2011 in Seattle, WA. The conference hosted 2,000 registrants including physicians, nurses, pharmacists, clinical research coordinators, clinical research associates, and other clinical research professionals. Continue reading

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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

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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

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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

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