Read here what's moving us right now.

Summary of the article for MEDIACC website (News section):
Artificial intelligence (AI) is revolutionizing healthcare: It optimizes medical processes, supports doctors with diagnostics and therapy, and relieves administrative tasks by automating administrative tasks. A thesis paper from the Federal Medical Association (BÄK) underlines the potential of AI, but at the same time emphasizes that medical expertise and final decisions remain irreplaceable. In order to effectively integrate AI into care, BAEK is calling for an adjustment of medical education — with a focus on digital skills, ethical-legal aspects and critical evaluation of AI tools. It is also crucial to use AI solutions specifically where they close supply deficiencies, for example through evidence-based prioritization.

As a specialist in clinical studies, MEDIACC welcomes BAEK's call for evidence-based validation of AI systems. Our core competence lies in demonstrating the medical benefits and supply effects of innovative technologies through rigorous studies. In AI applications in particular, clinical trials are essential to prove safety, effectiveness and suitability for practice — whether in diagnostic algorithms, treatment planning or patient monitoring. This is the only way to sustainably integrate AI tools into everyday clinical practice without undermining medical due diligence. MediaCC supports medical professionals and manufacturers in developing and testing AI solutions specifically for real care problems. Through our work, we are helping to ensure that AI is not only used innovatively, but also in a patient-oriented and compliant manner — always with the aim of increasing the quality of treatment and freeing up resources for human attention.

Hooray!

From April 8 to 10, 2025, it's that time again: DMEA, Europe's leading trade fair for digital health, will take place in Berlin. Global players from all over the world with innovations as far as the eye can see will meet. Of course, MEDIACC should not be absent from such a meeting, and so we will be represented with a stand in the “DiGA and Mobile Health focus area.”

Would you like to meet us there?

You can find us here:

Hall 2.2, stand number C-115

We're here:

Tue/Wednesday: 10:00 a.m. — 6:00 p.m.

Thu: 10:00 a.m. — 4:00 p.m.

About the program:

https://www.dmea.de/de/programm/gesamtprogramm/

We are looking forward to exciting discussions!

The whole team is delighted that our customer Smoke Free 23, whose path to the BfArM DIGA directory we have accompanied with a study lasting several years, has finally made it onto the list! Our smoke-free study with participants from all over Germany was the first of its kind to take place decentrally and completely digitally. The great effort and hard work are now paying off and we are proud of our customer, who persevered despite many unforeseeable hurdles and did not give up until the last participant was evaluated.

For us, this result proves that we have done a lot of things right, of which we are very proud. The experience we have gained in setting up this novel study will help us to pave the way for many more customers to join the DIGA directory in the future.

We wish Smoke Free 23 all the best and thank you for the great and fruitful collaboration.

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MEDIACC is pleased to announce a special award for our team: A member of our management team has been accepted into a worldwide network of outstanding scientists!

This nomination underlines the excellence and innovative spirit that MEDIACC has stood for since its founding in 2013.

Recognition at the highest level

Joining this exclusive network is confirmation of the groundbreaking work we do every day. We are thus joining a select group of around 100 leading international scientists who work together to pool knowledge, initiate new research and develop evidence-based recommendations for action.

Significance for MEDIACC

This award not only strengthens the profile of the nominated person, but also the spirit of the entire company. It underscores our position as experts in digital clinical trials and our commitment to improving medical care by supporting innovative technologies.

 We are convinced that this networking with leading scientists from all over the world will provide new impetus for our work. There will be opportunities for collaboration, sharing best practices, and developing cutting-edge solutions in clinical research, and we are looking forward to it.

MEDIACC warmly congratulates you on this outstanding recognition and looks forward to the exciting developments that will arise in the future.

The European Medicines Agency (EMA) recently launched the HMA-EMA catalogues for Real-World Data (RWD), which serve as comprehensive repositories for metadata from RWD sources and studies. These catalogs replace and expand the previous EU PAS Register® and EncePP Resource Database databases. They cover four main areas: data sources (238), studies (2976), institutions (770) and networks (178).

The aim of these catalogs is to help regulators, pharmaceutical companies, and researchers identify and use data to study the use, safety, and effectiveness of drugs. The catalogues are used to find suitable data sources, to evaluate the suitability of data sources, to improve interoperability between studies and data sources and to increase transparency. The EMA is currently (until 17.1.2025) carrying out a survey on the usability of the catalogues in order to further improve the system. For data owners, there are special instructions on how to access their previously published data sets in the new catalogs.

This initiative can lead to improved transparency and efficiency in medical research. Your success depends on the extent to which users can benefit from this.

Source and detailed information https://catalogues. ema. europa. eu/ (delete space for link)

“I have been working as a doctor at MEDIACC for a year, a competent partner for monitoring and carrying out clinical studies.

As part of my doctoral thesis, which I am writing at Charité in parallel, I was offered a stay abroad in Bangkok a few months ago. This opportunity appealed to me very much, but at the same time presented me with the challenge of having to work remotely at MEDIACC in the future.

Fortunately, I received support from MEDIACC in this project immediately after the decision was made. The departure to Bangkok was imminent and I had to be equipped with the necessary technology and know-how for remote work within a very short period of time. I was supported and promoted by the entire team.

Thanks to the well-thought-out programs and work processes at MEDIACC, I am now able to work seamlessly as a team and at the same time to operate independently from Bangkok. This flexibility is invaluable to me, as it allows me to continue to fulfill my professional obligations while moving closer to the goal of completing my dissertation. My work includes conducting patient interviews and handling sensitive data. As a doctor, I see it as my central task to ensure the well-being of my patients. Due to the strict data security measures, I can also do this from Bangkok.

I've been here in Thailand for several weeks now. Everything is new and strange, which can sometimes be challenging. I am all the more grateful that I can also work remotely with the people I know from working in Berlin at MEDIACC. The support from my team has helped me get used to it quickly and focus on my work.

Overall, I am very grateful for the support and effort that Dr. Schmidt-Lucke in particular has invested as my supervisor so that I can complete this stay abroad. The opportunity to work internationally while pursuing my academic goals is a valuable experience that advances my professional development.

I am looking forward to continuing to be part of the MEDIACC team and working together on innovative solutions in clinical research — no matter where I am. ”

— Ewa Brunner, study doctor at MEDIACC

Between standard and practice: Comparison of DIN EN ISO 14155 with national legislation

MEDIACC GmbH has submitted a request regarding the interpretation of certain aspects of DIN EN ISO 14155. This standard deals with clinical trials of medical devices on humans. After careful review and consultation with DIN experts, we are able to announce the following points:

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Terms and roles

The standard uses a number of terms that differ from the usual terms used in Germany in legal texts. This applies in particular to the roles and responsibilities of “clinical trial director”, “coordinating investigator”, “principal investigator” and “investigator” within clinical trials.

Practical implementation

In the practical conduct of clinical trials in Germany, these differences have not yet resulted in any significant problems. The competent ethics committees shall take into account the specific national requirements when evaluating them.

International cooperation

International studies often use different terms for senior examiners. In Germany, the role of “Head of Clinical Investigation” (LKP) remains the same, even though other titles are used internationally.

Continuous development

Standardization is a dynamic process. MEDIACC GmbH is closely following developments in this area and is in close contact with relevant experts and DIN and complies with the request to participate in the development of the new version of DIN EN ISO 14155.

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For detailed information on the interpretation of specific standard texts, we recommend that you contact the relevant DIN committee directly. We would also be happy to talk to you about this.

We are thrilled to have been there as a sponsor of the 4th d|a|ch symposium for clinical trials and investigations on September 16 and 17, 2024! The event was an excellent place to hold numerous stimulating discussions in an inspiring and friendly atmosphere. It was a pleasure to meet so many dedicated clinical research professionals and gain valuable insights into current trends and developments. A big thank you to the organizers and all participants for the opportunity to be part of this important event. We are proud to have financially supported this important event and look forward to future collaborations and sharing ideas!

The digital landscape of Europe reveals a remarkable paradox that hits our industry particularly hard. On the one hand, mobile working should be a reality and Deutsche Bahn prides itself on Internet availability, on the other hand, the German government is so lagging behind in European and international comparison that we must seriously worry about the future in Germany. While it is a matter of course for people in remote regions (including in the desert) to have high-performance Internet access, in this country this is like waiting for the long-awaited rain.

In no other leading research location is the oversleep of digitization so clearly evident. In particular, the discrepancy between political announcements and the actual implementation of necessary measures is unbearable. We have a particular responsibility to offer the next generation of researchers at least the opportunities that are self-evident in other countries. A look beyond borders reveals the full extent of the backlog.

Despite the first glimpse of progress, we remain the digital desert in many areas:

• Lack of digitization and lack of teaching about digital methods in the school and education sector
• Large-scale incomplete broadband expansion that makes efficient data transmission difficult
• Unreliable Internet on trains that hinders mobile work
• Outdated administrative processes that delay compliance with international standards
• Inadequate support for digital research processes

Authorities and governments in Europe and Germany must consistently implement the digital infrastructure. It is important to do everything possible so that the digital transformation, which has long since become a reality at other research locations, can also be implemented here consistently and in a future-oriented manner. It is high time to transform the digital desert into a prosperous digital research landscape so as not to fall even further behind in global competition.

To this end, we at MEDIACC will continue to work for you in the area of health research and ensure a continuous dialogue between research, politics and industry through participation in standardization committees and in discussions with national and global decision makers. Only through this exchange can we initiate the necessary changes and strengthen Germany as a location for innovative clinical research.

We are pleased to announce that MEDIACC has officially received the “advisory status within the meaning of the current funding guidelines for the promotion of business consultancies for SMEs” in the area of evidence generation for medical devices.

This enables us to support our customers as part of this important funding program. The program, which is co-financed by the Federal Ministry of Economics and Climate Protection and the European Social Fund Plus, aims to support small and medium-sized enterprises (SMEs) in overcoming entrepreneurial challenges.

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For SMEs, our consulting covers all issues, in particular for the design of clinical trials of innovative products, including medical devices. This applies both to the generation of evidence as part of a conformity assessment process (CE certification), to extension of indications, to medical apps in the therapeutic or diagnostic sector, including DiGA and DiPA.

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As a registered consultant with the Federal Office of Economics and Export Control (BAFA), we meet strict quality standards. We have an appropriate quality assurance tool and ensure that advice is carried out properly, in accordance with the guidelines.

The funding rate is either 50% and a maximum of 1,750 euros or 80% and a maximum of 2,800 euros of consulting costs. Companies can receive funding for two consultations per year.

Contact us to find out more about how we can help you submit your application and help you further develop your innovative product with this funding.

MEDIACC is at your side as a competent partner to overcome your business challenges together and strengthen your company for the future.

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