Tag Archives: protocol

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

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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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Statistical Reviews of Case Report Forms

A statistical review of a trial case report form (CRF) is highly important for various reasons. The project statistician is aware of the planned primary and secondary endpoint analyses and knows what data will be needed to implement these analyses. … Continue reading

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Protocol Development: Focus on the Right Objectives

Every clinical study starts with the development of a clinical protocol, a document that describes how a clinical trial is to be conducted.  Clinical protocols are not only a regulatory/GCP requirement, but are absolutely essential to ensure a clinical study … Continue reading

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Clinical Trials in South Africa 101

South Africa has a mixture of both first and third world diseases and a large number of experienced research sites, making the country an excellent location for clinical trials in many indications. As we are a southern hemisphere country, recruitment … Continue reading

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