PSURs
PSURs for Product Safety
With the development of periodic safety update reports (PSURs), we support companies that are specialists in diverse areas in the pharmaceutical industry. In the framework of PSURs, the safety of an active substance is documented based on a risk-benefit analysis carried out at the international level. This detailed and well-substantiated analysis serves above all as documentation for submission to authorities. We additionally provide translation services in numerous languages.
At some stage or other, the risk-benefit ratio of a product is always crucial to its future in the marketplace. Further to PSURs, and in cooperation with long-standing partners in the area of international product safety, we provide clinical trial supplies services, to include: the labelling, packaging, storage and shipment of medicinal products and medical devices. If required, Dr. Oestreich + Partner GmbH will manage the randomisation and the preparation of emergency envelopes for your clinical trials. A 24-hour expert hotline is operational for decoding in the event of an emergency and the reporting of serious adverse events. Furthermore, we offer telemedicine devices for the monitoring of the safety and efficacy of treatment procedures.
PSURs and Further Documentation
In the clinical research area our well-qualified and expert team offers its services in the development of further documentation. In addition to PSURs, study protocols, case report forms (CRFs), electronic case report forms (eCRFs), electronic data bases for the archiving of images from diagnostic procedures, patient information and informed consent forms (ICF), applications for clinical trial authorisation to competent authorities and ethics committees, the reporting of serious adverse events (SAE), the writing of expert reports and clinical study reports, and information on medicinal product characteristics, plus documentation for doctors and public relations material are developed. If required, PSURs and medical texts can be translated into other languages.
The company Dr. Oestreich + Partner GmbH develops PSURs through the expertise of a highly competent, multi-disciplinary team, with long-standing experience in hospital and university medical research units, in clinical research and development, and market research institutions in the US, Germany and all other European countries. In addition, Dr. Oestreich + Partner GmbH routinely draws on the expertise of external consultants and key opinion leaders that underpins the Company’s internal competencies.
