Pharmaceutical companies are obliged in accordance with § 67 AMG para.6
“To gather information of already approved or registered medicinal products and to immediately inform the competent federal authority, the Federal Association of Statutory Health Insurance Physicians, the central association of health insurance companies and Federation Association of Private Health e. V. In this, place, time, destination and observation plan of surveillance must be specified, as well as the involved physicians by name and the lifelong physician number have to be appointed to the physicians’ Confederation and the umbrella Association of Health Insurance.”
A post-marketing surveillance (PMS) study has the goal to document and evaluate data of a variety of patients. Since in this form of study, no inclusion and exclusion criteria exist, it can be worked on issues, which cannot be clarified in the context of clinical trials. PMS studies are very well adapted to answer questions about prognosis, tolerance, survival, quality of life, benefits and costs of treatment.
We take over the efficient planning, competent conduct and in-depth evaluation of your post-marketing surveillance study (PMS).
Our experts will gladly advice you personally. We look forward to your call or your message.