ICH GCP E6

ICH GCP E6 – Good Clinical Practice (GCP) Guideline

The company, Dr. Oestreich + Partner GmbH, has been entrusted with the successful conduct of clinical studies in the prevention, treatment, care and economics of disease for many years. We strictly adhere to the ICH GCP E6 guideline in all relevant work processes. Our international network of local monitors and partners with ICH GCP E6 experience additionally provides us with great flexibility in the different medical indications for the prevention, treatment and care, in addition to the health economics of diseases.

Clinical trials must be reliably performed in accordance with the ICH E6 GCP guideline. In the same manner, the statistical analysis of the data and the compilation of the final clinical study report require a high level of experience. Our experts have acquired their know-how through many years of experience in global research companies, academic institutions or hospitals. Our highly qualified team provides our customers with a comprehensive full-service clinical package. We manage national and international clinical research projects in all areas of medical product development. The design of clinical trials from phase I through to phase IV including biometric aspects is carried out in accordance with the ICH E6 GCP guideline. At the same time our employees ensure the timely involvement of key responsible personnel. The team creates and prepares official documents and notifies authorities of the participation of investigators according to the respective and applicable national regulations.

ICH GCP E6 Project-based Instruction

Prior to study start, all participants receive detailed and activity-based instruction in order to provide a strong basis for the specific responsibilities within the project and to comply with ICH GCP E6. During the study the Project Manager, Monitors and internal staff remain in close contact with the customer’s project manager and with the clinical investigators via telephone or e-mail. Our web-based technology systems, OPVERDI and PMSBOX, enable the creation of individual, multi-lingual eCRFs. In addition, data from special investigations, for example, laboratory reports, ECG, imaging techniques, such as ultrasound and similar, or telemedicine self-monitoring of patients, can be integrated into the database. In addition to electronic monitoring, our databases enable the completion of further procedures without the need for on-site presence at the study centre.

A review of the conduct of clinical studies according to the ICH GCP E6 guideline is found here:

http://www.oandp-cro.com/quality-assurance/


EMEA 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
CRO – Clinical Research Organisation
CRO – 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

EMEA 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 · CRO – Clinical Research Organisation · CRO – 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