Digital Trials Center

Digital health solutions manufacturer

Overview of partial services:
– Study planning incl. Evaluation concept
• Setup incl. Ethics application, configuration of the platform (DTM), recruitment and connection of study physicians, study registration
– Recruitment of study participants
– Registration and education of the study participants
– Data collection from care providers and study participants
– Administration of the study implementation
– Quality management and monitoring
– Statistical study evaluation
– Medical Writing (Study Report)

Study results based on a GCP compliant, manufacturer independent clinical study. The study is designed, prepared, conducted, evaluated and exploited (report, publication) by the dmac. The implementation of the study is focused on a digital, decentralized approach.

You can address different goals with the study results. This includes the approval of medical devices (clinical evaluation), market access for (regulated) reimbursement (e.g. proof of efficacy) or post-market surveillance of a medical device to demonstrate safety and performance. In addition, results of a clinical study can be used for the advertising/marketing of a product (MPG Advertising Act).

The dmac acts as a one-stop store for a clinical trial with a digital, decentralized study concept, provides strategic advice on a suitable reimbursement model and collects the necessary clinical data with the DTC.