Cliniserve is most recognized and reliable monitoring company offering monitoring services in clinical research field. We are highly qualitative in our work.
The Purposes of Trial Monitoring Are To Verify That
- The rights and well-being of human subjects are protected.
- The reported trial data are accurate, complete, and verifiable from source
- The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with the applicable regulatory requirement(s).
Cliniserve performs below listed monitoring tasks for bioequivalence study
Study Design & Planning
- Cliniserve will help to develop best study design based on nature of molecule
- We can draft the best strategy to make sure your product meet the acceptance criteria
- The goal of the Protocol Review is to promote the highest scientific quality.
- During review we ensure that the protocols utilize scientifically sound and appropriate research methods and statistical analysis.
- We review the protocol designed by site and give our valuable feedback.
- We ensure that protocol covers all major aspects of study.
- We make sure that protocol summaries all the primary and secondary outcome of your product.
Monitors of Cliniserve carry our listed monitoring visit to ensure protocol compliance
- Site Initiation Visit
- Period 01/02/03/04 – Check-in & Dosing day monitoring
- In-process Bioanalytical Monitoring Visit
- Retrospective Bioanalytical Monitoring Visit
- Close-out Monitoring Visit
- Pharmacokinetic & Statistical Data Monitoring