Proper planning, realistic expectations, and experienced confidence - Mindset

Brief overview of Operational services provided:

Protocol review

ICH E6 (R2) ready

Process review and improvement

Feasibility review and final site/country selection recommendations

Budget and timeline development, forecasting, and review

TMF internal structure design

Core SOP development

Vendor identification

Clinical study Drug supply operations planning and forecasting

RFP design and follow through

Establish Risk Based Monitoring approach

Key Performance Indicator identification and implementation

Study plans review

Site contract negotiation point of contact

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