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.
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