SAE and SUSAR Management

As outlined in ICH E2A, E6 (GCP), and EU Clinical Trial Regulation (CTR) No 536/2014, sponsors are responsible for the timely collection, assessment, and reporting of these events to health authorities and ethics committees.

PVpharm supports sponsors, CROs, and biotech companies in the efficient management of Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) throughout the entire clinical safety lifecycle, ensuring full compliance with ICH and EU regulatory requirements.

Our services include:

• SAE Case Intake and Processing: Efficient collection, medical review, and documentation of SAEs from investigators, sites, or partners, ensuring timely handling and high data quality.
• SUSAR Detection and Reporting: Identification of SUSARs through causality and expectedness assessment, followed by submission to relevant authorities (e.g., EudraVigilance, MHRA, FDA) and ethics committees within mandated timelines.
• Narrative Writing and Medical Review: Preparation of medically accurate and regulatory-compliant narratives, including consistency with protocols and investigator brochures.
• Regulatory Compliance Monitoring: Tracking and management of reporting timelines and documentation to ensure compliance with global regulations, including EMA and FDA requirements.
• Safety Database Entry and Coding: Entry and MedDRA coding of SAE/SUSAR data into validated safety databases, with full audit trail and quality control.
• SAE Reconciliation: Periodic reconciliation of SAE data between clinical and safety databases to ensure consistency and inspection readiness.
• Training and Process Integration: Provision of training for site staff and sponsors on SAE/SUSAR handling, and integration of procedures into your clinical trial workflow.