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With the recent changes in regulatory scenario and developments in terms of newer regulations, the number of clinical trials conducted in India continue to increase. The focus on quality has increased with more and more emphasis on investigator oversight. Therefore, there is an increased need for qualified investigators and site staff to conduct these studies. Oversight of these study activities is critical. While India has one of the world’s largest and most experienced physician population with over 8,00,000 physicians across the country, the number of clinical research-experienced and GCP-trained clinical investigators is still low. These physicians typically have very large daily patient loads (1 doctor for ~1,700 patients) and lack the time to run and oversee a clinical study effectively without assistance. Compounding the issue even further, ELS research has found that less than 10% of all investigative sites in India have a research unit or a full time clinical research coordinator on staff.
Site Management Services from Excel Life Sciences help take the burden off of investigators so they can focus on patient care, and ensure the study is conducted at the highest standards of quality, ethics and performance. This support ensures collection of high- quality study data necessary for regulatory and product approval submissions. Our proven site support model involves placing a full-time, highly qualified and trained clinical research coordinator at each study site. They are there to assist the investigators and site staff with all day-to-day study conduct activities.
The coordinators at our site management organization are trained to provide professional assistance to the investigator ensuring compliance with FDA, local regulatory and ICH-GCP guidelines. Supported by an experienced project management team, the study coordinator can have a significant impact on the quality, ethics and performance of the site.