GCP Guidelines

GCP Guidelines at Dr. Oestreich + Partner GmbH

In the area of clinical project management, the company, Dr. Oestreich + Partner GmbH, consequently follows the GCP guidelines. The Company has been responsible for the successful conduct of clinical trials since 1991 and as such the GCP guidelines have long been incorporated into our SOPs (Standard Operating Procedures). Through our extensive international network of local monitors and partners, we are able to operate flexibly in a variety of medical areas in the prevention, treatment, care and economics of disease.

As a full-service clinical research organisation, we support our customers from the initial planning stages onwards. We contact all the required key personnel at a sufficiently early stage and coordinate projects through project management according to the GCP guidelines. Our services include the development and editing of all required documentation, from the submissions to the competent authorities and ethics committees, through to the preparation of the protocol, CRF and the final clinical study report in accordance with GCP guidelines.

GCP Guidelines - Project Structure

Individual and multilingual eCRFs are efficiently prepared in accordance with GCP guidelines through our online databases OPVERDI and PMSBOX. These two EDC (electronic data capture) systems also allow the integration of electronic data from special investigations such as ECG (electrocardiogram), medical images, laboratory findings or telemedical devices. In this way global and real-time insight into the status of the clinical study being performed is possible for authorised users without them needing to be physically present at the study site.

Prior to the commencement of a clinical study, all project team members are thoroughly trained on the entire workflow, in addition to their respective individual responsibilities, in the framework of the GCP guidelines. This ensures a structured approach for all concerned. We manage clinical trials from phase I through to phase IV. We recruit and instruct study sites and clinical laboratories, and we provide personal both on-site and online monitoring, audits and other quality assurance measures, respectively. Our expert team is there for you at all times, to ensure best compliance with GCP guidelines.

An overview of the conduct of clinical studies according to GCP guidelines can be found here:

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


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

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