A stabilising buffer in biological applications
Compliance with this standard ensures public assurance that the rights, safety and well-being of the trial subjects are protected consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical data are credible.
Quality assurance in clinical trials is one of our main tasks.
• that all our (study) personnel are well-trained
• that all parties involved receive comprehensive information on their tasks and that they are fully aware of the importance of quality in clinical trials
• the establishment and strict observance of suitable operating procedures
• the generation of trial documentation according to the requirements of the sponsor.
In the ICH-GCP glossary, quality assurance is defined as a process in which all planning and systematic measures are implemented to ensure that trials are conducted and data is generated, documented and reported in compliance with the guidelines on GCP and applicable regulatory requirements.
Quality control includes all operation techniques and activities undertaken within the quality assurance system to verify that all requirements relating to the trial quality are fulfilled. Monitoring is the act of overseeing the progress of a trial, and of ensuring that it is conducted, recorded and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and the applicable regulatory requirement(s).
In order to guarantee these requirements, we have developed a quality management system that was certified by German Lloyd in 2006. The certification was confirmed by a monitoring audit in 2007.