OCT’s pharmacovigilance specialists prepare high quality safety reports within the allotted timelines
All studies are driven by patients' safety as a priority. With over 30,000 patients recruited into our projects since 2005, we place high importance on introducing patient centricity principles into every stage of a trial.
With that in mind, the OCT pharmacovigilance team covers a range of safety monitoring and safety reporting tasks and responsibilities in the course of a study.
Drug development is a costly and time-consuming process. Therefore, it is vital to obtain all-encompassing information on drug safety to ensure its speedy marketing authorization and prevention of unfavorable outcomes.
Safety Manager, MD, PhD
We guarantee that all safety information is collected and reported to investigators and appropriate regulatory authorities within the required timelines.
We ensure safety reporting of your study:
• Set up of PVG specific processes and procedures
• Collection, description and processing of serious adverse events data
• Evaluation of safety data
• Data entry and MedDRA coding
• Medical review, quality control
• Reporting to regulatory authorities and investigator sites about presumed serious and unforeseen adverse reactions (SUSAR)
• Preparation and submission of annual safety reports to regulatory authorities and investigator sites
Thanks to the experience of our specialists in the field of pharmacovigilance and their regulatory expertise, we prepare high-quality safety reports within the required timelines.
* - Required fields