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SITE MANAGEMENT

Site Management Services from Excel Life Sciences take the burden off investigators conducting clinical trials in India. Our processes allow them to 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 data necessary for regulatory and product approval submissions.

Our proven comprehensive site management model involves placing a full-time, ELS employed clinical research coordinator (CRC) at each study site to assist the investigators and site staff with all day-to-day study conduct activities. The CRCs 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 CRC has a significant impact on the quality, ethics and performance of each 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 at the site and our highly skilled project and site management personnel; we ensure the data coming out of the investigative site for your study is of the highest quality possible. We have the experience, bandwidth and technology necessary for on-time database lock and the commitment to make it happen.

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

Pre-Trial

  • Identify sites & PIs
  • Document collection
  • Regulatory submission & approval with rapid turn-around time.
  • Obtain import licenses for CTS.
  • EC submission & approval with rapid turn-around time.
  • Identify and coordinate translation of essential documents.
  • Identify couriers and other support service vendors.
  • Site set up
  • Create source document template.
  • Pre-screening in case of chronic disease trials.

During the Trial

  • Assist in the ICF process, screening & enrollment.
  • Implement recruitment & retention strategies.
  • Manage patient follow-up visits.
  • Manage CTS accountability, distribution & logistics.
  • Coordinate Central Lab logistics.
  • Coordinate monitoring & audit visits.
  • Subject reimbursements.
  • Maintain and update Trial Master File.
  • Coordinate SAE reporting & payments on time.

Post-Trial

  • Resolve data queries.
  • Coordinate close out visit.
  • Final CTS accountability & return to central pharmacy.
  • Final commercial reconciliation.
  • Archival at site
  • CSR sign off