Our Site management service will give you clear benefits in terms consistency and data quality of the trials conducted. We will help our clients in reducing the administrative or management support that a sponsor would otherwise need to
provide individually to each site.
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Leads will identify the right site for the trial – one that fulfills all the criteria set forth by the clinical trial guidelines and trial protocol. Evaluate the site’s access to the appropriate subject population – whether the required number of subjects can be enrolled within the stipulated time. Assess the site infrastructure to find out about availability of space, equipment, trained manpower to handle particular equipment, ancillary facilities such as laboratories, pharmacy etc, and communication facilities.
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A clinical trial must be supervised by a qualified person in accordance with applicable regulations and clinical guidelines. These qualifications may vary depending on the disease or therapeutic treatment under investigation such as cancer research. Leads have database of experienced investigators for conducting the specific trials.
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Patients or volunteers are the backbone of any clinical study and make a very valuable contribution to the testing of the efficacy of a drug. Of all clinical trials conducted globally, more than 80 percent are delayed due to slow patient recruitment. This delay may cost the pharmaceutical companies millions of dollars per day in terms of lost sales.
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Our Ethics committee members consist of both medical professionals and non medical professionals.All IEC members are trained in ICH GCP and other regulatory guidelines.Our IEC ensures that the protection of rights, safety and well being of the subject involved in the trial and also ensures that the trial is conducted in a proper manner according to protocol and regukatory guidelines.
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