Study safety is guaranteed in the following ways:
- Establishment of pharmacovigilance processes and procedures;
- Safety data assessments;
- Obtaining data on serious adverse events, as well as describing and processing them;
- Data entry and coding by MedDRA;
- Medical assessment and quality control;
- Informing regulatory authorities and research sites about suspected unforeseen serious adverse reactions;
- Preparation and submission of safety reports to regulatory authorities in all countries involved in the study;
- Preparation and submission of an annual safety report to research sites.
Based on extensive experience in the field of pharmacovigilance and a deep understanding of regulatory aspects, OCT specialists prepare high-quality safety reports within specified time frames.
