caraka logo

Site Management Services

We help the hospitals to set up a Clinical trial Unit (CRU) for managing Clinical trials. Dedicated GCP trained professionals to conduct clinical research in well-equipped Ayurveda Clinics/Hospitals and Allopathy Hospitals, Team of Ayurveda physicians trained in various branches as medical experts, Collaboration with other hospitals for need-based clinicians, Experienced in conducting Whole systems studies, clinical trials, and observational studies for the effect, efficacy, and safety of AYUSH-based treatment. Drug trials for herbal formulations as per the GCP guidelines, Community based studies to explore the potential of Ayurveda-based interventions in India, and conducting trials in all major therapeutic areas.

Pre Trial Activities

  • Identify potential GCP trained sites / Principal Investigator.
  • Provide GCP training to PI & study team at a regular basis.
  • Provide GCP trained Clinical Research coordinators for every site.
  • Identify and coordinate preparation & submission of essential documents to CRO/ Sponsor.
  • Ethics committee submission & approval with turn-around time.
  • Site set up & essential document preparation.
  • Create source document template if applicable.
  • Prepare site for Site Initiation Visit.
  • Pre-screening/ pre-identify cases for competitive trials

During Trial

  • Assist the Investigator in the ICF process, screening & enrollment.
  • Implement recruitment strategies
  • Maintain source documents in guidance with Investigator team.
  • Completion of CRF/ eCRF with in specified timelines
  • Maintain and update Trial Master File.
  • Dispense Investigational product & maintain drug storage & accountability as per the requirements.
  • Coordinate Central Lab logistics & sample flow.
  • Coordinate subject follow-up visits & preventing lost to follow up
  • Coordinate subject reimbursements.
  • Coordinate SAE reporting on time and maintain documentation.
  • Coordinate and maintain the ethics committee documentation during the study.

Post Trial Activities

  • Coordinate close out visit
  • Resolve data queries on time in coordination with Investigators
  • Archival of Data
  • IP Destruction

Charaka clinical and translational sciences © 2022. All rights reserved.