We make your medical devices reimbursable

Through our market-oriented and efficient clinical trials, we help your healthcare innovations become reimbursable.

Science as a Service

Experts for digital clinical trials

Our goal is to achieve reimbursability of your medical devices by health insurers with innovative digital solutions and customized studies.

Completely digital or hybrid clinical trials

We are experts in implementing digital and hybrid study designs that meet the needs of your projects.

Clinical investigations of medical devices

We conduct pre- and post-certification clinical investigations to ensure the safety and efficacy of your medical devices.

Generate evidence for DiGA

We create the best trials for your digital health applications to provide compelling evidence for your products' reimbursability.

Strong network

We connect you with competent partners to successfully implement your projects.

From evidence to market-wide acceptance

We do more than just clinical trials

From strategy development to operational implementation to publication - we guide you through the jungle of regulations to market-wide acceptance.

Strategy development

Work with us in a workshop to develop initial content for your study. Bring all questions to the table: Together we eliminate uncertainties and find individual solutions for your product.

Concept

Together we outline a customized study and project concept in a kick-off meeting.

We bring you together with our competent cooperation partners for your study success.
You want a digital study implementation? We will be happy to advise you on the possibilities of digital elements.

Planning & Preparation

Let us fill your study concept with life!

We prepare essential study documents for submission to the competent authority (e.g. BfArM) and ethics committee and support you in preparing for talks with the competent authorities.

We prepare everything from work instructions to kittel pocket synopses to certificates.

Implementation / Clinical Phase

We will ensure the smooth conduct of your clinical trial, including training of study personnel and monitoring of study progress.

Closing and utilization of results

Now the database can be closed and evaluated. We create a clinical study report and help you present your results internationally and convince with evidence.

"We want to make the world a better place for those affected, with robust clinical trials as a necessary step for innovation in tomorrow's medicine."

Company Director PD Dr. med. Caroline Schmidt-Lucke

Get to know MEDIACC
Medical app on prescription

Your DiGA in the DiGA directory of the BfArM

We support manufacturers of digital health applications (DiGA) in demonstrating a positive effect on care and inclusion in the BfArM directory. Here, we use our experience from discussions with the BfArM to their understanding of the evidence requirements.

Literature research and evaluation

With the systematic literature review, we ensure a clean rationale for the chosen study design and all study elements.

Evaluation concept

We help you develop an evaluation concept that meets the requirements of the BfArM and shows why and how the evidence of the medical benefit of your product is demonstrated.

Systematic data evaluation

Our expertise in systematic data evaluation supports you in reviewing the effectiveness of your DiGA.

Randomized controlled trial

With the appropriate randomized controlled trial (RCT), we support you in proving the positive supply effect for inclusion in the DiGA list of the BfArM and reimbursement by health insurance companies.

Show the medical benefits of your product

With our many years of experience and expertise, we offer effective solutions to demonstrate the medical benefits of your medical device.

From the design to the implementation of registry studies to randomized controlled digital trials, we support you with tailor-made services.

Find out how MEDIACC can help you get your products reimbursed.