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.

Click here to find out more about the investigator audit at Dr. Oestreich + Partner:

Investigator audit

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.

Click here for an overview of our services relating to investigator audits:

Investigator audit

EMA Pharmacovigilance
Health care studies
Observational studies
EMA Pharmacovigilance
Medical Biometrics
Approval of Medical Devices
Clinical Investigators
Clinical Trials
GCP Legislation
GCP - Good Clinical Practice
GCP Guidelines
GCP Compliance
Clinical Research Organisation
Contract Research Organisation
Pharmacoeconomics, Health
Pharmacoeconomic studies
Patient Monitoring
Monitoring Clinical Trials
Clinical Monitor
Marketing Authorisation
Medicinal Product Approval
Drug safety
Data management plan
Clinical development
Monitoring investigators
Non-interventional studies (NIS)
Patient recruitment
Phase IV studies
Investigator audit
Investigator qualification
Investigator selection

EMA Pharmacovigilance · Health care studies · Observational studies · EMA Pharmacovigilance · Medical Biometrics · Approval of Medical Devices · Pharmacovigilance · Clinical Investigators · Clinical Trials · GCP Legislation · GCP - Good Clinical Practice · ICH GCP E6 · GCP Guidelines · GCP Compliance · BfArM GCP · Clinical Research Organisation · Contract Research Organisation · PSUR · PSURs · Pharmacoeconomics, Health · Pharmacoeconomic studies · Pharmacoeconomics · Patient Monitoring · Monitoring Clinical Trials · Clinical Monitor · Marketing Authorisation · Medicinal Product Approval · Drug safety · Data management plan · Clinical development · Monitoring investigators · Non-interventional studies (NIS) · Patient recruitment · Phase IV studies · Investigator audit · Investigator qualification · Investigator selection