Clinical Operations

Tailor-made solutions from CRO selection to Last Patient Last Visit

CRO Selection	Risk Assessment	Site Selection	CRO Oversight
Define tasks to be outsourced Request RFIs to CROs Prepare RFPs Evaluate CRO proposals Attend Bid defence meetings Define CRO partnership model Review CRO agreement	Define critical processes and data Define KPIs Evaluate risks at Sponsor level Evaluate risks at CRO level Evaluate risks at product level Evaluate risks at study level Mitigate all risks	Define selection criteria Perform database search Review feasibility questionnaire Review PSV reports Propose final list of sites for SIVs	Write CRO oversight plan Compliance of essential documents TMF plan & QC SIV/MVR reports review Study plans review Site activation approval Best meeting practices Co-monitoring visits Third-party vendor qualification Escalation & governance charter