Case Studies


Phase IV study requiring full service support (excluding regulatory)

Short term (only nine months active) study; (first patient visit Jan 2008, last visit first patient October 2008, last visit last patient end of July 2009) The sponsor aims at recruiting 3000+ in ten months.

Scope of work

Phase IV study requiring full service support (excluding regulatory)

Agent

A Phase IV, randomised, double blind, study of the efficacy and safety of a titrated dose of a long-acting ACE inhibitor in comparison with an up titrated antagonist in mild to moderate hypertension

The Challenge

Short term (only nine months active) study; (first patient visit Jan 2008, last visit first patient October 2008, last visit last patient end of July 2009) The sponsor aims at recruiting 3000+ in ten months, therefore there washigh pressure on selecting well recruiting sites , and careful monitoring of data input at the sites (a site can have up to 50+ recruited patients) and therefore regular frequent monitoring visits were crucial to the success of the study.

The CCA Approach – recognising the main challenge on this study is maintaining high recruitment levels at the sites and at the same time ensuring data quality CCA embarked on providing well trained and experienced Clinical Research Site Managers to each site making them available at any time to the site staff to answer queries and assist in patient recruitment.


The Outcome

We met the study targets; each site managed to recruit the required number of patients

 

 

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