Investigator audit - Dr. Oestreich + Partner GmbH
An investigator audit is an audit carried out during a clinical study, in which compliance with the guidelines of good clinical practice (GCP), the requirements of the ethics committees and with the study plan is checked. Investigators in a clinical study must therefore have the relevant experience with regard to the knowledge of the requirements of the GCP guidelines, the ethics committees and project management in the context of clinical research. Quality assurance measures are also reviewed as part of the investigator audit.
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Information, seminars and competent advice on the investigator audit
Dr. Oestreich + Partner provides effective support in investigator audits. Our expert staff compiles all documentation required for an investigator audit for our clients, both for the auditing pharmaceutical companies and for the investigator site. Upon request we will also coordinate the selection of investigator sites and investigators and establish all necessary contacts with the required institutions and regulatory authorities. We are also happy to arrange licensing and the editing of medical and scientific informational publications. Before the start of a clinical development project we will train all staff involved with regard to their specific tasks and provide efficient coordination of the tasks to implement studies while saving time and money. We hold regular events and seminars at our training facilities in Cologne, during which we also provide comprehensive information on the requirements of investigator audits. We offer both standard and customized training programs for research, marketing and sales staff.
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