As a principal communication hot-link between the sponsor
and the investigator, we are responsible for overseeing the progress
of the study according to the study protocol and GCP guidelines. We
are also responsible for:
•
Ensuring protocol compliance
•
Study sample management
•
Subject screening and recruitment
assistance
•
CRF filling
•
AE and SAE reporting
•
Data management
•
Investigator selection
•
Investigators meeting coordination
•
IRB clearance
•
Query resolution Data storage in secure cache,
accessible over the web to authorized persons
Our network of specialists together with a vast database
allows access to numerous patients immediately, reducing the enrollment
time.
Primary auditing by experienced site monitors ensures
high quality data. Dedicated full time site manager to each study
ensures further protocol compliance. Excellent interpersonal communication
skills help us in providing day-to-day support service to the investigators.
Frequent and open interactions with the clients help
in identifying trends in protocol and reflect further in the progress
of the study.