Evaluation Concepts
Key questions answered
For whom?
Digital health solutions manufacturer
How is the service defined?
Overview of partial services:
- Study design
- Study protocol
- Statistical analysis plan
In the run-up to a clinical study, a comprehensive evaluation concept must be drawn up. The concept describes the medical background as well as the addressed gap in coverage of the application used and plans a detailed study implementation as well as the analysis of the study data.
What does the customer gain from this?
A sound and detailed evaluation concept reduces the risks involved in conducting and evaluating the planned clinical trial. In addition, an evaluation concept in its entirety (DiGA) or in parts (ethics application) is required by regulation in advance of a study.
Why with the dmac?
An evaluation design requires an understanding of the medical care context of the application being evaluated. The dmac has in-depth knowledge of how digital medical devices of diverse indications can be integrated into a study design and has extensive expertise in the regulatory requirements for study implementation of different reimbursements (DiGA, DiPA, selective contract).
For whom?
Digital health solutions manufacturer
How is the service defined?
Overview of partial services:
- Study design
- Study protocol
- Statistical analysis plan
In the run-up to a clinical study, a comprehensive evaluation concept must be drawn up. The concept describes the medical background as well as the addressed gap in coverage of the application used and plans a detailed study implementation as well as the analysis of the study data.
What does the customer gain from this?
A sound and detailed evaluation concept reduces the risks involved in conducting and evaluating the planned clinical trial. In addition, an evaluation concept in its entirety (DiGA) or in parts (ethics application) is required by regulation in advance of a study.
Why with the dmac?
An evaluation design requires an understanding of the medical care context of the application being evaluated. The dmac has in-depth knowledge of how digital medical devices of diverse indications can be integrated into a study design and has extensive expertise in the regulatory requirements for study implementation of different reimbursements (DiGA, DiPA, selective contract).
Your message to us
Do you have questions about your digital health solution, possible reimbursement channels or the German healthcare market? The dmac is at your side with all its expertise – our competent team will be happy to support you.
Contact us with your request via the form and we will get back to you as soon as possible!
