Effective pharmacovigilance is essential to protect trial participants and to ensure continuous compliance with regulatory safety requirements throughout clinical development. CRS provides comprehensive pharmacovigilance services designed to support accurate safety monitoring, timely reporting, and proactive risk management across all study phases.

We support sponsors in the collection, assessment, and reporting of adverse events in accordance with applicable EU and international regulations. Our services cover safety data processing, medical review, and regulatory reporting, including the management of serious adverse events (SAEs), suspected unexpected serious adverse reactions (SUSARs), and periodic safety reports. Clear procedures and defined timelines ensure consistent and reliable safety oversight.

CRS works closely with investigators, sponsors, and third-party safety providers to establish efficient safety communication pathways. We support site training and ongoing guidance to ensure correct event identification, documentation, and escalation. Particular emphasis is placed on early-phase and first-in-human studies, where rapid safety signal detection and immediate response are critical.

Our pharmacovigilance activities are fully integrated with clinical operations and project management, enabling real-time safety oversight and coordinated decision-making. We support safety committees, dose escalation governance, and protocol amendments related to emerging safety findings, ensuring that risk mitigation measures are implemented without delay.

By applying a structured, compliant, and risk-focused approach, CRS helps sponsors maintain high safety standards, meet regulatory expectations, and ensure the ethical and effective conduct of clinical trials throughout the study lifecycle.