PSUR - Periodic Safety Update Reports
Our experienced and expert clinical research team can support you further in the writing of periodic safety update reports (PSUR). In the PSUR an in-depth risk-benefit analysis of the investigational medicinal product (carried out at the international level) is presented. The aim of this analysis is to document the safety of an active substance for the attention of the competent authorities amongst others.
Naturally, we also provide medical translation services for the translation of PSUR into different languages.
We place great emphasis on customer-oriented service and working to international standards, not only in the development of PSUR, but for all projects that we manage for companies and institutions in the pharmaceutical, biotechnology, medical device, diagnostic, medical technology, cosmetic, nutrition, luxury foodstuffs and consumer goods industries. Our highly-qualified, multidisciplinary team of personnel with many years of experience is well matched to the task of writing PSUR. Our services in this area are being built up steadily at the international level and this continuous expansion is underpinned by our exacting quality assurance measures. Thus, for the development of PSUR, we additionally provide a sound basis for close cooperation and open lines of communication with our customers.
PSUR and Dr. Oestreich + Partner GmbH Further Services
In addition to the writing of periodic safety update reports (PSUR), Dr. Oestreich + Partner provides services in the development of other types of medical documents. These include 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 to competent authorities and ethics committees for clinical trial authorisation, the reporting of serious adverse events (SAE), the writing of expert reports, clinical study reports, and information on investigational medicinal product (IMP) and medical device characteristics, plus documentation for doctors and public relations material. The translation of medical texts and PSUR is also part of the wide range of services provided by Dr. Oestreich + Partner GmbH.
Furthermore, in the marketing area, we offer pharmacovigilance (product safety) services. In cooperation with our long-standing partners we are also able to provide, in addition to PSUR, expert clinical trial supply services, to include labelling, packaging, storage and shipment of medicinal products and medical devices.