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Designing and Conducting a successful Healthcare Effectiveness and Outcomes Research study

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A leading global pharmaceutical company was looking for a fit for purpose technology and methodology to evaluate the eff ectiveness of an anti-psychotic drug in terms of relapse, adherence to treatment and patient outcomes.

The data was needed to support reimbursement submissions (HTA) around the globe. The company wanted to run the study using their own resources and needed software to help manage the types of site interactions appropriate to non-interventional research.

The study was built with multilingual support, a clean and simple data entry process that was not based around a traditional e-clinical model but rather matched more closely the working practice of the doctors. Features were built in to support user communities and sharing of study outputs.

Over the subsequent 9 years (2003-2011), this Health Economics study was deployed to 19 countries, 9,500 patients, 1579 sites, and was run in 8 languages. The study averaged 2 protocol amendments per year across 17 protocol variations.