BfArM GCP

GCP – BfArM Guidelines

Since 1991, Dr. Oestreich + Partner GmbH has provided a highly qualified and successful full service package for clinical research at national and international levels. The Company carefully adheres to the GCP requirements of competent authorities, such as the German BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte), in addition to the goals of our customers.

Our team consists of experts with many years of experience in diverse medical areas (prophylaxis, treatment, care and economics), which can manage for you, on both a national and international basis, the preparation of all necessary documents for government agencies and ethics committees in accordance with the GCP requirements of the competent authority(ies). At the same time we provide consultancy with respect to financial planning and budget control and we ensure that all key personnel are involved in a timely manner. We undertake project management (Phase I to IV) and prepare the necessary paper-based case report forms (CRFs) or internet-based (eCRF).

Good Clinical Practice - Data Reliability and Protection of Patients

During the entire realisation of the project, our internet-based documentation systems and OPVERDI and PMSBOX are made available. They provide authorised users with real time access to the actual status of all relevant data, within the framework of current data protection legislation, without the need to visit the study site. Through the application of the data bases, customized and multilingual electronic CRFs (eCRF) can be created in which the results of specific procedures such as laboratory investigations and imaging techniques (ultrasound, CT, etc.), or the self-monitoring of patients through the means of telemedicine can be integrated. Basically, all of our content management systems and documentation systems ensure reliability and accuracy, as well as data security and the protection of patients in accordance with the legal (e.g. BfArM) and GCP (Good Clinical Practice) requirements.

The increasing overall requirements and the numerous constraints from legislation and guidelines that are imposed on clinical studies and projects in health services research and economics means that all project personnel must receive appropriate instruction. To this end, we organise comprehensive, certified training for all project staff to ensure that all parties are familiar with their responsibilities and the project workflow with respect to GCP and the requirements of national competent authorities such as the German Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM).

A review of the conduct of clinical studies according to the legal and GCP requirements of BfArM is found here:

http://www.oandp-cro.com/consulting/


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