Early Access Programs Management
MEDIKAPOLI CRO provides comprehensive Early Access Programs (EAP) Management services to support patients’ timely access to investigational or unapproved therapies prior to full marketing authorization. Our expert team ensures that Early Access Programs are designed, implemented, and managed in full compliance with local regulations, ethical standards, and applicable international guidelines.
We support sponsors throughout the entire EAP lifecycle, including program design, regulatory and ethics submissions, patient eligibility management, site coordination, safety reporting, and ongoing communication with health authorities and ethics committees. All activities are conducted with a strong focus on patient safety, transparency, and regulatory compliance.
Through our structured and patient-centered approach, MEDIKAPOLI CRO helps sponsors minimize regulatory risks, streamline approval processes, and ensure the efficient and ethical execution of Early Access Programs, ultimately enabling responsible access to innovative therapies while maintaining the highest standards of quality and compliance.