As the number of clinical trials conducted in India continues to increase at a rapid pace, so does the need for qualified investigators and site staff to conduct those studies. While India has one of the worlds largest and most experienced physician populations with over 600,000 physicians across the country, the number of clinical research-experienced and GCP-trained clinical investigators and is still low. Also, these physicians typically have very large daily patient loads and lack the free time to run 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 full time clinical research coordinator on staff.

Site Management Services from Excel Life Sciences help take the burden off of investigators so that they can focus on the patient, and ensure that 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 comprehensive site support model involves placing a full-time, highly qualified clinical research coordinator at each study site to assist the investigators and site staff with all day-to-day study conduct activities. The coordinators at our site managment organization are trained to provide professional assistance to the investigator ensuring compliance with FDA, local regulatory and ICH-GCP guidelines and efficient completion of mandated tasks. Supported by an experienced project management team, the study coordinator can have a significant impact on the quality, ethics and performance of the site.

ELS offers the following site management services: