The key to success, when it comes to well-managed and -conducted clinical trials, is the implementation and execution of Quality Assurance (QA) principles throughout the lifetime of a trial. High-quality SOPs, processes that are thoroughly prepared and GcP principles are the foundation of which clinical trials should be built.
Quality assurance services include
Quality Management Systems (QMS)
Building an entirely new QMS can be a comprehensive and time-consuming task. Let us help you to define your needs and create a system, that is efficient and transparent. The QMS will be easily managed with a sufficient level of compliance.
Site audits or inspections
Whether the audit or inspection will take place at a clinical site or on the sponsor’s premises, you want to be well prepared for the event. We offer services essential for preparation and conduct of a successful audit or inspection. In extension of the visit we can assist you to identify and describe the corrective and preventive actions (CAPA).
QA Advice
We are working according to GCP and ICH guidelines. While you have the knowledge within your therapeutic area, you can rely on us to be your QA expert. We ensure that your trial will be executed with the highest quality measures, from the first initial steps of planning, through the actual conduct of the trial to the outcome.
SOPs/templates/guidelines and processes
We can assist you, in preparing new documents, revise existing ones or to develop a training management system, that will ensure you that all your employees are updated with every process.