Clinical Operations
Phase 1:
We have expertise in conducting clinical studies in phase1. We have experience in setting up new facilities for conducting phase 1 studies and provide customized services as per sponsor requirement to accelerate the drug development process to execute through next phase of the study.
Phase 2 & 3:
We have expertise in conducting phase II and phase III trials with the help of experienced resources in clinical operation team and selecting trained sites that fulfil the requirement and conduct the trials ethically. Our team is expert in recruitment and hold 1st and 2nd position worldwide in phase II and III studies. For retention of subjects in order to get the evaluable data our team works very efficiently with site.
Phase 4 and observational Studies:
We have vast Investigator data in all therapeutic areas for conducting phase IV and observational Studies. With the experience of conducting trials in multiple therapeutic areas we have been associated with the sites with large patient pool mostly Government setup in order to complete the enrolment target in timely manner.
We have dedicated team for patient and physician survey, analysing health records, patient registries and generating prospective data generation. Medical writer with the help of Data analyst and Bio stat team helps the client for final publication.
Site Selection and Initiation:
- Site feasibility and initial assessment; identification of potential investigational sites
- Scheduling and conduct of site selection visits
Site and Supply Management:
- Maintain regular communication with sites
- Track and manage subject recruitment
- Notify sites for updates
- Review monthly site performance
Interim Monitoring and Closeout Visits:
- Plan, schedule and conduct investigator/site visits including all on-site activities and send follow-up visit report
- Conduct site closeout visits, review all site reports and open action items beforehand, and submit study closure forms for IRB/EC