CRA for BE study/New drugs/Medical devices
1.Clinical research study setup/study procedure setup/site staff training
2.Site monitoring visits/source data verification/deviation reporting in compliance with GCP
3.Trial documents maintenance/regular site visits and maintenance/study materials supply/interim reports
4.regular report to sponsor/communication between sponsor and site.
5.site close-out/trial materials retrieval
6.audits/regulatory inspection participation upon request