GCP - Good Clinical Practice (GCP) – Standard Operating Procedures (SOP

GCP Operating Procedures at Dr. Oestreich Partner GmbH

In our clinical research organisation, standard operating procedures for the conduct of clinical trials in accordance with GCP have long been in place. Our company was founded over 20 years ago and has successfully completed many multi-national clinical trials. All studies have been carried out in strict compliance with GCP Standard Operating Procedures. At the same time we have carefully pursued our customer’s objectives.

Through our employees, our customers have access to a highly qualified and experienced clinical project team that carries out all procedures in accordance to established GCP Standard Operating Procedures and in a goal-oriented manner. All our experts have many years experience in academic institutions, internationally active research companies or hospitals.

We design a customer-oriented project plan and prepare the documentation for competent authorities and ethics committees according to GCP compliant Standard Operating Procedures. During the entire project, we work with you proactively and in a consultative capacity with respect to budget control and account management. At the beginning of a clinical project, we instruct project team members on their individual tasks according to GCP Standard Operating Procedures, and thus establish a strong foundation for project success.

GCP - Work Instructions and Comprehensive, Proprietary Databases as Standard Operating Procedures for Good Clinical Practice

Multilingual eCRFs can be created quickly and efficiently through our Internet-based EDC software solutions, OPVERDI and PMSBOX. In addition, special test results such as ECG, laboratory tests, imaging or telemedicine self-monitoring of patients, can be integrated therein. In this way, all authorised project team members are able to access comprehensive and to-date data, even when they are not able to visit the study centre. In addition to accuracy and reliability, our documentation and content management systems also ensure privacy and security for patients both in terms of data protection legislation and in accordance with GCP compliant Standard Operating Procedures.

Detailed information on our clinical research projects carried out in accordance with GCP compliant Standard Operating Procedures 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