GCP Legislation, fulfilment of requirements according to GCP
At the company Dr. Oestreich + Partner the fulfilment of the requirements laid down in GCP legislation with careful orientation to the objectives of the client is at the forefront for all clinical research projects. Our full-service clinical research organisation has been successfully supporting clinical studies for more than 20 years in the prevention, treatment, care and health economics of all medical conditions. GCP legislation is routinely implemented in all work processes as described in our SOPs.
Through our highly qualified staff, an articulate and competent team is available to our customers. The team provides full support to our customers from the initial planning through to successful completion of a clinical trial in the areas of prevention, treatment, care, and health economics. GCP legislation is followed closely throughout.
Project Training in Accordance with GCP Legislation
We develop a budget, time and goal-oriented plan and are well versed in ensuring the early involvement of all key players. Our staff is pleased to carry out the generation and processing of medical texts according to the requirements of GCP legislation; from the dossiers for submission to competent authorities and ethics committees, the preparation of the protocol, CRF and the final clinical study report through to editorial texts. These documents and texts are also translated as required. Furthermore, we also ensure that authorities are notified regarding the participation of investigators in a clinical study according to national legislation, and we recruit and train study sites in addition to laboratory personnel.
During the entire project, our internet-based EDC databases are available that allow authorised personnel real-time access to the current study data, and thus ensure a high cost efficiency and low travel costs. Prior to the start of the research project, all project staff receives qualified and certified instruction, in order to ensure that the study is structured and conducted in accordance with GCP legislation.
Detailed information on clinical research in accordance with GCP legislation can be found here: