Evaluation Concepts

We prepare a comprehensive evaluation concept in advance of a clinical trial. 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.

Key questions answered

Digital health solutions manufacturer

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.

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.

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).

Digital health solutions manufacturer

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.

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.

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!

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