Pharmacovigilance & Drug Safety for Phase I-II

Safety oversight is not a standalone function, it is a core component of successful early development. INVENTIO science’s pharmacovigilance specialists support early-stage biotechs and academic sponsors with pragmatic drug safety expertise across clinical and post-marketing phases, helping identify risks early, maintain compliance, and ensure high-quality safety reporting aligned with evolving regulatory expectations.

Our Pharmacovigilance & Drug Safety Services Include:

• Clinical trial SAE and SUSAR case processing
• Medical review and safety assessment
• IND/CTA safety reporting and regulatory submissions
• Development Safety Update Reports (DSURs)
• Investigator safety communications
• Scientific literature surveillance
• Ongoing safety monitoring and emerging signal assessment
• Risk evaluation and mitigation strategy support
• Regulatory safety consultation and health authority responses