Clinical research organization India
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clinical research trials india  Comprehensive Trial Management

Site Management Services

As the number of clinical trials in India continues to expand at a rapid pace, so does the need for new investigators to conduct those studies. While India has one of the worlds largest and most experienced physician populations with over 600K across the country, the number of clinical research experienced and GCP trained clinical investigators is still very 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 sties in India have a full time clinical research coordinator on staff. Site Management Services from Excel Life Sciences help you navigate this difficult operating environment, 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 placement of a full-time, highly qualified clinical research coordinator at each study site to assist the investigators and site staff with all day-today study conduct activities. Our coordinators 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. Specifically, ELS offers the following site management services:

 

Pre-Trial
During the Trial
Post Trial
  • Identify sites
  • Identify PIs
  • Identify and coordinate translations of Essential documents
  • Identify Couriers and other support service vendors
  • Regulatory submission & approval with rapid turn-around time
  • Obtain import/export licenses for CTM & Samples
  • IRB submission & approval with rapid turn-around time
  • Site set up
  • Document collection
  • Create source document template
  • Prepare site for SIV
  • Pre-screening, in case of chronic disease trials
 
  • Assist in the ICF process, screening & enrollment
  • Coordinate subject follow up visits preventing lost to follow up & missed visits
  • Manage CTM accountability, distribution & logistics
  • Coordinate Central Lab logistics & sample flow
  • Coordinate Monitoring & Audit visits
  • Subject reimbursements
  • Maintain and update Trial Master File
  • Coordinate SAE reporting on time
 
  • Coordinate close out visit
  • Resolve data queries
  • Archival at site