Excellent Medical Writing Services

Clinical trials and the marketing of medicines are subject to strict regulations of the European Medicines Agency (EMA) and are laid down in the German Medicines Act (AMG) to ensure transparency, fairness, ethical correctness and compliance with Good Clinical Practice (GCP).

 

Documents written in lay language are essential, as they promote ethical decision-making and ensure patient-centered medical communication. The results and designs of clinical trials must be transparent, published, and communicated to physicians and patients in their respective national languages. Patients must be empowered to make informed and independent decisions.

 

Once a drug is on the market, reporting and pharmacovigilance within the post-market surveillance (PMS) process ensure that it is well monitored. Medical information is continuously disseminated to physicians and healthcare professionals and the content of the materials has to be in compliance with regulatory documents and latest safety updates.