GCP Legislation

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:

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