As a freelance CRA I offer you following service:

Routine monitoring:

Routine monitoring is performed according to ICH GCP rules, FDA guidelines and local regulatory requirements. The main monitoring activities are: site Source Data Verification (100%), CRF review, staff training, Protocol compliance control, regulatory requirements compliance control, drug inventory and accountability, safety review, documentation maintenance and updates.

Other kinds of CRA activities at the sites:

Feasibility, site selective (pre-study) visits, site initiation visits, site close out visits, secondary monitoring activities, site preparation before incoming audits, DCF flow and management.

I am able to help you with preparation of EC and RA submission.