A central component of quality management is the creation of standard operating procedures (SOPs) in order to define the processes and the framework for compliance and to be able to check them during the course of the study. These written procedures must be regulatory compliant and meet the legal requirements. At the same time, it is important that SOPs are designed to be practical and do not create unnecessary hurdles in the workflow.

Our established quality management is continuously optimized and adapted to new requirements. If desired, we can create SOPs for your own quality management that meet both the regulatory requirements and the specific requirements of your clinical trial processes. In this way, we ensure transparent, traceable processes and guarantee the objectivity and consistency of your data.

We ensure a high level of employee qualification through regular training.

Audits are important tools to ensure that a clinical trial is conducted in accordance with the protocol, Standard Operating Procedures (SOP) and the requirements of Good Clinical Practice (GCP). Sponsors or authorities can carry out an audit to check the processes – or have it carried out by an independent body. This involves a systematic review of all or individual aspects of study-related procedures and documentation.

We provide you with comprehensive support, both through study-specific audits (system audits or site audits) or in the event of an announced regulatory inspection during or after a clinical trial. This includes preparing the necessary documents, optimizing processes and communicating directly with the authorities. Our aim is to prepare you for the audit or inspection in the best possible way and to ensure that your clinical trial meets the highest standards. On request, we can also audit the selected trial sites in advance of a trial in order to identify and avoid potential risks.