Module 1.10 Service Provider Selection

Select a Module Module Details Review Materials Take Quiz Evaluate Module Print Certificate

Module 1.10: Service Provider Selection provides an overview of the structured, risk-based approach required to identify, evaluate, and manage service providers that support REMS programs. The module outlines key selection criteria, alignment with REMS strategy and internal operations, and common supplier types, including program administrators, technology providers, and analytics partners. It walks learners through the end-to-end process—from initial assessment and RFI/RFP development to sponsor due diligence, evaluation, selection, and contractual approval—while emphasizing regulatory compliance, audit readiness, and documentation. The module also addresses ongoing oversight, periodic audits, reassessment, and business continuity planning to ensure sustained compliance, operational resilience, and patient safety throughout the lifecycle of a REMS program.