Rayfacts maintains rigorous safety monitoring processes to ensure compliance with ICH-GCP, NDCT 2019, and global regulatory frameworks. All adverse events (AEs) and serious adverse events (SAEs) are systematically captured, assessed, and reported within regulatory timelines. Our team coordinates with investigators, ethics committees, and sponsors to evaluate safety signals, manage risk mitigation strategies, and maintain accurate pharmacovigilance documentation. This structured approach ensures both participant protection and regulatory adherence across all clinical programs.
Adverse Event Tracking: Continuous collection, documentation, and evaluation of all adverse events (AEs) and serious adverse events (SAEs).
Regulatory Compliance: Ensuring timely reporting to Ethics Committees, DCGI, and other authorities as per ICH-GCP and NDCT 2019 requirements.
Risk Management: Identifying safety signals early, assessing causality, and implementing corrective or preventive measures.
Data Integrity: Using validated systems and EDC platforms to ensure accuracy, confidentiality, and traceability of safety data.
Stakeholder Communication: Regular updates to sponsors, investigators, and oversight bodies through safety reports and line listings.
Training & SOPs: Continuous training of site staff and internal teams on pharmacovigilance, safety reporting timelines, and documentation standards."