Site Management
We help the hospitals to set up a Clinical trial Unit (CRU) for managing Clinical trials. SMOconnect is working with 50 Multispecialty Hospitals and 10 Medical Colleges hospitals across South India and is conducting trials in all major therapeutic areas.
Pre–Trial Activities
- Identify potential GCP-trained sites / Principal Investigators.
- Provide GCP training to PI & study team on 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 a source document template if applicable.
- Prepare site for Site Initiation Visit.
- Pre-screening/ pre-identify cases for competitive trials
- Planning Recruitment Strategies
During the trial
- Assist the Investigator in the ICF process, screening & enrollment.
- Implement recruitment strategies
- Maintain source documents in guidance with the Investigator team.
- Completion of CRF/ eCRF within specified timelines
- Maintain and update Trial Master File.
- Dispense Investigational products & maintain drug storage & accountability as per the requirements.
- Coordinate Central Lab logistics & sample flow.
- Coordinate subject follow-up visits & prevent loss to follow-up
- Coordinate subject reimbursements.
- Coordinate Monitoring and audit visits.
- 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