Patient safety is a central aspect in any stage of clinical research and the primary measure required for this purpose is the adequate processing of any reported adverse event (AE) and potential side-effect. Prompt and profound medical assessment of such safety reports is the basis for expert surveillance of the trial’s benefit/risk-ratio and for the protection of the participating patients. The fulfillment of regulatory requirements indicates a qualified and accurate management of individual case safety reports.
We offer full-services Safety and Pharmacovigilance solutions for each step in planning and conducting all phases and types of clinical trials. Our team manages the study relevant safety data and presents if required by regulatory standards clear and comprehensive annual Data and Safety Update Reports (DSURs) and Safety Summary Reports (SSRs) to study-related Data and Safety Monitoring Boards (DSMBs) – competent groups of independent experts external to the trial. DSMBs convene at periodic intervals and their establishment and management are clearly prescribed by a specific charter developed by palleos.
Self-dependently validated systems and processes that meet state-of-the-art quality standards and fulfill all regulatory requirements serve as the basis to meet your needs and expectations. Our highly qualified and experienced team continuously ensures proficient, reliable and stable case management and ongoing data analysis while our internal quality management ensures the constant improvement of advanced workflows. Easily accessible individual contact offers quick and expert, solution-orientated assistance to support you and to make a success of your sophisticated projects.