Non-Interventional Studies are an elegant and cost efficient way to document or verify efficacy, safety, tolerability and patients’ quality of life of licensed products after mono- or combination therapy. A well planned NIS may increase the drug´s overall success following publication of high quality scientific data. However, NIS are strictly regulated by the Drug Law in Austria, Germany and other member states of the European Union. To classify a trial as non-interventional, the following requirements have to be met:
Sponsor: Under the Austrian and German Regulations, the Sponsor is an institution or individual that takes responsibility for the initiation, management and financing (or the arranging financing) of a study.
Our Company offers the planning, conduct and overall management of NIS in Europe. For this purpose, we are utilizing a unique computerized online data entry system, allowing us to remain up-dated about the progress of subject recruitment and data quality at any point in time. Data are continuously collected and monitored assuring the highest possible degree of transparency and data quality. Therefore, our studies are conducted in full compliance with international standards and exceed regulatory requirements. You are cordially invited to have a look at our recent publication (in german) reporting on the usefulness and the new options available through utilizing NIS. (Publication-NIS)
Would you like more detailed information or have questions regarding our services? We would be happy to provide you with a tailor-made, preliminary proposal for your project.
We offer you the full range of services regarding non-interventional studies. Depending on your needs we provide the following services to your company: