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Services

Site Management Services from Excel Life Sciences help take the burden off investigators planning to do clinical trials in India 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 management 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.

Clean, high-quality data is one of the most critical elements of any clinical trial. Therefore, site management is a core service of Excel Life Sciences and a critical part of our overall customer value proposition. Between the full-time dedicated clinical research coordinator we place at the site and our highly skilled project and site management personnel; we ensure that the data coming out of the investigative sites for your study is the highest quality possible. We have the experience, bandwidth and technology necessary for on-time database lock for any study that we take on and the commitment to make it happen.

ELS offers the following
site management services
for clinical research in India:

  • Pre-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
  • EC submission & approval with rapid turn-around time
  • Site set up
  • Document collection
  • Create source document template
  • Pre-screening, in case of chronic disease trials During the Trial Assist in the ICF process, screening & enrollment
  • 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 Post-Trial Coordinate close out visit
  • Resolve data queries
  • Archival at site