We facilitate reimbursement eligibility for your medical devices.
Through our market-oriented and efficient clinical trials, we pave the way for your healthcare innovations to become reimbursable.
Science as a Service
Experts for digital clinical trials
We aim to support you in securing reimbursement for your medical devices by leveraging cutting-edge digital technologies and customised clinical trials.
We offer full-spectrum assistance from the initial study concept to the utilization of the results.
Study design
Work with us to design a well thought-out study and project concept based on the needs and requirements of affected individuals and relevant service providers.
Fully 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.
From evidence to market-wide acceptance
Our expertise extends far beyond conducting clinical trials
From strategy development to operational implementation to publication — we are here to guide you through the jungle of regulations to market-wide acceptance.
Strategy development
Join us in a collaboartive workshop to develop the preliminary framework for your clinical trial. We welcome open dialogue: together we mitigate uncertainties and develop individual solutions for your product.
Clinical trial concept
Together, we create a customised study and project concept in a kick-off meeting.
Your clinical trial is our priority; we will connect you with our trusted network of partners. Exploring digital trial methodologies? Our team offers expert advice on implementing digital solutions.
Planning & Preparation
Together, we will transform your clinical trial concept from vision to reality!
Our team prepares essential study documents for submission to the competent authority (e.g. BfArM) and ethics committee and supports you in preparing for regulatory consultations.
From standard operating procedures to pocket synopses and certificates - we prepare everything you need to succeed.
Conducting your clinical trial
We will ensure the smooth conduct of your clinical trial, including training of study personnel and monitoring of study progress.
Completion and utilisation of results
With completed data collection, we move to database closure and in-depth analysis. Our experts will compile a clinical study report and collaborate with you to present your results internationally, ensuring your evidence makes a powerful impact.
"Our mission is to improve the lives of patiens worldwide, recognising robust clinical trials as an essential pathway to advancing future medicine."
Company manager PD Dr. med. Caroline Schmidt-Lucke
Get to know MEDIACCMedical app on prescription
Your DiGA in the DiGA directory of the BfArM
Our expertise aids innovators of digital health applications (DiGA) in generating evidence of positive healthcare effetcs and navigating DiGA directory listing. Our approach is informed by our ongoing dialogue with BfArM, ensuring a clear understanding of their criteria and expectations.
Literature research and evaluation
We conduct comprehensive systematic literature reviews to substantiate sound rationale for the chosen study design and all elements.
Evaluation concept
We support you in the development of an evaluation concept that meets the requirements of the BfArM and details the approach and justification for substantiating your product's medical benefit.
Systematic data evaluation
Our expertise in systematic data evaluation supports you in reviewing the effectiveness of your DiGA.
Randomised controlled trial
With the appropriate randomised controlled trial (RCT), we support you in proving the positive healthcare effect for the successful listing in the DiGA directory of the BfArM and, therefore, reimbursement by health insurance companies.
Demonstrate 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 randomised controlled digital trials, we support you with tailored services.
Find out how MEDIACC can support you in achieving reimbursement of your medical device.