Evidence generation experts
Systematic literature research and thorough data evaluation
We are experts in evidence generation: In order to identify suitable methods and instruments, we conduct a thorough systematic literature research, if necessary. Have you already generated initial application or user data for your product? We would be happy to design an initial data evaluation. It may be possible to avoid a costly clinical study.
Integration of digital elements
Our approach considers the potential for digitalization and cost savings in your study right from the start. We advise you on the requirements for an electronic data capture system and other digital elements such as electronic signatures or medical video consultations. Benefit from our extensive network of qualified market-leading providers and our expertise in interface coordination.
Keep flexibility
Decide on the basis of a responsibility matrix which processes or sub-processes will be taken over by us or our partners or even by yourself - this way you keep flexibility in budget calculation and we can develop a project management plan for efficient study planning and execution.
Ensuring compliance
Compliance with international and national regulations
We ensure that all processes comply with international (ISO 14155, ICH-GCP, MDR, IVDR, DSGVO) and national regulations (BÄO, BMV-Ä, MPDG). The data of your study participants are protected by our certified information management system (ISO 27001).