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: