Clinical Operations

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

CRO SelectionRisk AssessmentSite SelectionCRO 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