The Challenge

The increasingly complex legislation within the EU and the rising costs for doctors and clinics make it difficult to carry out these scientific clinical trials with low budgets. For investigator-initiated studies (PIS) or investigator-initiated trials (IIT), the same legal rules apply for research into medicinal products and medical devices as for studies initiated by industry.

Within the framework of IITs, investigators or clinics assume the role of the sponsor, thereby being responsible for ensuring patient rights and safety, as well as achieving high data quality and integrity. Bearing this extremely high and strictly controlled responsibility with manageable financial budgets and a limited number of personnel deters most doctors and clinics from conducting IITs. We find this to be very unfortunate!

Klick here to learn more about Our Solution.