Global Non-interventional study
| Client |
A leading global pharmaceutical company |
| Project Summary |
Patients: 9,600
Investigators: 1570
Countries: 19
1 year retrospective, 2 years prospective data
This registry was initially deployed in 2003 across two countries. By 2008 it was expanded to17 countries. Because e-STAR handles the data management workload, the client has been able to monitor the study using their own in-country staff.
e-STAR provides investigators with intelligent data entry screens via a standard web browser. At the backend the system uses a robust and secure data store with fully anonymous patient records. Through online validation and quality checks the system delivers cleaned datasets to health economists earlier than with previous studies. |
| Brief |
A registry to capture data on the worldwide use of a newly-approved anti-psychotic. |
| Benefits |
- e-STAR has simplified the process of data capture and validation when monitoring naturalistic studies.
- e-STAR has allowed the client to run the study using in-country staff and a CRO for data analysis.
- e-STAR has meant that patient data is available earlier than with other, more manual, methods.
- e-STAR has been easy to deploy worldwide, as it is accessed via a standard internet browser.
- e-STAR has improved the relationship between the client and its study investigators.
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| Outcomes |
The system has been in use for over five years and currently has gathered data on nearly 6000 patients. So far over 50 publications have been written using this data. The study will gather more than 30,000 patient years of data. |