Program design and process setup
We design and set up early access programs with clear workflows and regulatory compliance.
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Continuous safety monitoring and reporting is essential for protecting patients enrolled in Early Access Programs (EAPs). At MedWatch Consulting, we establish robust pharmacovigilance (PV) processes that ensure timely collection, assessment, and submission of adverse event data.
Our services cover AE/SAE collection and documentation, medical review, regulatory reporting, and periodic safety updates. We also integrate safety data into existing PV databases to maintain consistency and traceability across all sources.
By combining regulatory compliance with operational efficiency, we give sponsors confidence that their Early Access Programs are conducted under the highest standards of patient safety and data integrity.
We design and set up early access programs with clear workflows and regulatory compliance.
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We manage EAP compliance across markets, ensuring privacy, documentation, and audit-ready records.
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