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