Monday, 16 January 2012

Remote Monitoring Of The Clinical Trial Data Increases Its Efficiency


The increasing technology has spread the scope of the clinical trial globally. Numbers of clinical trials today are running in the developing countries. Monitoring the clinical trial in person has become a major challenge to FDA in these scenarios. The major focus of FDA in conducting the monitoring in person is to protect human subjects, while maintaining data integrity and compliance with regulations. Evaluating the study conduct of the clinical trial with the frequent visits to the clinical trial remained as a predominant method in the clinical trial. To cut the travel expenses and time span, FDA now encourages onsite monitoring of the clinical trial data at the regular intervals. 

Most of the government sites are still not using centralized monitoring effectively; they still visit the clinical site once in two or three years to certify the safety of the clinical trial.  FDA urges the use of remote monitoring to ensure 100 percent safety of the clinical trial data. Using onsite remote monitoring fraud and fabrication, may be more readily detected says FDA. In spite of relying on the centralized monitoring of the clinical trial data, one should prefer on-site mentoring at least once in the early stages of the clinical trial.

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