Pharmacovigilance

Pharmacovigilance in accordance with the EU guidelines

As a full-service CRO (Clinical Research Organisation), Dr. Oestreich + Partner GmbH provides professional and effective consultancy in the area of pharmacovigilance. Consultancy services are provided in the context of the safety monitoring of medical products both pre-market and post-market approval in accordance with the European Medicines Agency (EMA) pharmacovigilance guidelines. Our employees have many years of experience in the relevant areas and provide our customers with an expert service package of medical and technical advice for pharmacovigilance projects. Thanks to our broad network of experts, we operate flexibly in the diversest medical areas and draw on many years of pharmacovigilance experience in clinical research projects at both the national and international level. Dependent on our customers’ requirements, we carry out planning and management of projects (for example, Post-Authorisation Safety Studies (PASS), Non-Interventional Studies (NIS) and Safety Observational Studies)) including implementation and monitoring of the projects. In individual cases, the adverse effects are also recorded, evaluated, reported and followed up in order to ensure that measures are put in place to minimise any risk and to obtain marketing approval. We ensure that the required key personnel are notified in a timely manner. We also create or prepare the necessary medical documents, from study outlines through to official documents for submission, including any translation work.

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Pharmacovigilance requires rapid access to reliable data

Pharmacovigilance projects require careful compilation and processing of data. With our software solutions PMSBOX and OPVERDI, we provide our customers with proprietary online databases with strict regard to their application in the field. Both software systems may be accessed over the internet by appropriately authorised personnel and their application results in an accurate and reliable data structure. Through the use of these databases, customized and multilingual electronic CRFs (eCRFs) can be created in which, for example, the results of external data from ECG, ultrasound or laboratory findings can also be integrated.

Click here for an overview of our pharmacovigilance services

http://www.oandp-cro.com/clinical-research/product-safety/


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