Early Access Programs

Early/expanded access programs enable patients to receive promising treatments outside of clinical trials while maintaining full regulatory and safety oversight. At MedWatch Consulting, we design and implement Early Access Programs (EAP/CUP/NPP) that balance timely access with robust compliance and patient protection.

Our services cover the full spectrum of program design and process optimization, including eligibility criteria, informed consent, workflows, forms, and defined responsibilities. We prepare SOPs and provide comprehensive training for all participants, while establishing clear communication channels among physicians, sponsors, and regulatory authorities. When needed, we integrate existing pharmacovigilance systems and databases to ensure consistent data entry and monitoring.

We deliver robust safety oversight and reporting—including AE/SAE collection, deadlines, and periodic reports—while ensuring full compliance with FDA Expanded Access guidelines, EMA expectations, and national EU regulations, including GDPR. The outcome is a program that is inspection-ready, fully transparent, and focused on patient safety.