Study design, Protocol development, inclusion / exclusion criteria, study conduct, medical monitoring, data analysis and interpretation, and evaluation of clinical safety information.

Interactions with Investigators and site staff, responding to medical questions and queries for the site, ensuing adherence to study protocol including safety management guidelines

Review and assess all protocol violations, including significant, non-significant deviations with study team.

Protocol amendment, SAE reconciliation, writing of CSR, IB update, DSUR update

Other related activities