Freelance monitoring services

IBCR has network of freelances Clinical Research Associates (CRA) with large experience monitoring and managing clinical trials in India. We have experience in managing clinical trials in all development phases (phase II, III and IV) and can offer a well established and reliable freelance structure in order to meet efficiently your requirements.

IBCR has self-motivated and territorially located professionals whose skills range from monitoring to clinical project management which enables project savings on the cost of travel, budgets, and time. IBCR individuals has knowledge of local regulatory and ethics expectations which can avoid delays caused by conducting a trial in diverse cultures, with differing regulatory requirements, medical practices, and languages.

IBCR can assure best time management and high productivity site monitoring activity with consistency and stability. IBCR freelance work force holds backup support and contingency plans to ensure immediate resource cover in the event that unforeseen circumstances occur.

Routine monitoring service

Routine monitoring is performed according to ICH GCP rules 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.

Trial management service

Study 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; IRB and RA submissions.