The safety and effectiveness (efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use is studied under Clinical Research. It is the bloodline of all medical advances.
We have a team of
We can provide a well organized, methodically planned and carefully conducted trial for your reseach.
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
· Planning Recruitment Strategies
During the 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 Monitoring & Audit visits.
· Coordinate SAE reporting on time 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
· CRF design, printing & distribution
· Database design & setup
· Edit checks programming
· Double data entry
· Data validation & discrepancy management
· Medical coding
· SAE reconciliation
· Integration of third-party data
· Database lock & archival