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MEDIACC: Celebrating Our Nomination as a Top 10 Clinical Trial Services Provider in Europe 2024

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At MEDIACC, we are thrilled and honoured to announce our recent nomination as one of the “Top 10 Clinical Trial Services Providers in Europe 2024.” This prestigious recognition demonstrates our continuous commitment to innovation, digital advancement, international collaboration, and scientific excellence.

First and foremost, we are immensely proud of our innovative leadership team, whose visionary guidance has propelled us to the forefront of the clinical research industry. Through their bold decision-making and forward-thinking approach, we have been able to redefine traditional trial practices and explore groundbreaking methodologies that drive medical innovation forward.

Our dedication to digital advancement has been a cornerstone of our success. We have invested significant resources in developing cutting-edge digital processes and structures specifically tailored for decentralised clinical trials of medical devices. By leveraging digital technologies, we have revolutionised trial procedures, enhanced patient accessibility, and accelerated the pace of medical progress.

Furthermore, our commitment to international collaboration has been instrumental in shaping our success. Through strategic partnerships with leading institutions and organizations worldwide, we have built a global network of expertise that enriches our research capabilities and fosters cross-cultural exchange.

Above all, our unwavering dedication to scientific rigor and quality has set us apart. From study design to data analysis, we uphold the highest standards of integrity and rigorously adhere to regulatory guidelines. Our team of skilled researchers and scientists ensures that every aspect of our work meets the most stringent criteria for validity and reliability, resulting in findings of unparalleled quality and credibility.

In Conclusion, Our Nomination Underscores Our Dedication to Excellence and Innovation in Clinical Research, Driving Us to Continuously Push Boundaries, Improve Patient Outcomes, and Shape the Future of Healthcare.

MEDIACC goes DMEA 2024

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For two days, we were represented at one of the most innovative trade fairs with MEDIACC and took advantage of the unique opportunity for personal exchange with a wide variety of national and international companies.

It is our aim to constantly and constantly improve our digital, decentralized clinical studies and to keep pace with innovations. The visit to DMEA provided the perfect platform for this: We had groundbreaking and intensive discussions with suppliers, manufacturers of market-oriented products, potential partners and customers as well as “old hands” and returned to the office full of exciting visions.

Successful accreditation of our AFORCE-1 study by the German Cancer Society's Colorectal Cancer Study Board

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We are pleased for our customer about the positive evaluation of the AFORCE-1 study by the German Cancer Society's Colorectal Cancer Study Board! Since 05.04.2024, the study on early cancer detection using a new blood test has been listed in the StudyBox under registration number ST-U178. The StudyBox is an internet-based platform that is currently being implemented as a pilot for colorectal cancer centers. Our study thus meets the criteria for recognition of the study within the certification system and is thus becoming more attractive for our test centers in the Berlin area.

Excellent clinical studies as an answer to the dilemma of statutory health insurance companies — not only in the reimbursement of DiGA

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In its latest and third DiGA report, the National Association of Statutory Health Insurance Funds for the Supply of Digital Health Applications (DiGA) summarizes. The board member at the National Association of Statutory Health Insurance Funds, Stefanie Stoff-Ahnis, demands equal treatment with other benefits reimbursed by statutory health insurance funds. DiGA is only granted the “potential” of medical benefit if there are “low entry requirements for DiGA when proving its benefits” and insufficient “economic efficiency.”

These statements are an affront to companies, which are undergoing a very complex process seriously and with great effort for innovative therapies. Equally against those responsible at the Federal Office for Drugs and Medical Devices (BfArM), who interpret the legal framework in such a way that even the provisional inclusion of a DiGA in the so-called DIGA directory requires higher standards of study quality and scientific evidence than the medical devices currently reimbursed, e.g. in the list of aids of the National Association of Statutory Health Insurance Funds, or when known useless therapies have ever been the case.

This undifferentiated and ill-considered presentation picked up by the press not only harms manufacturers but also all patients by preventing real innovation. Instead, the same scientific evidence requirements apply to all treatment options and fair payments for all services and to all care providers in this country should be considered and implemented based on facts.

Completely digital clinical studies at MEDIACC: innovative, efficient and people-oriented through cutting-edge technology

MEDIACC is defining the future of digital clinical trials by implementing international laws and recommendations, in particular the EMA guideline for computer-based systems, for clinical trials.

In a lighthouse project, we successfully carried out a completely digital study, which recruited over 2000 study participants to test an innovative health app using a telemedicine approach. The digital study platform integrates an electronic data collection system (EDC) with additional digital modules and newly thought-out proven processes to ensure the highest quality and reliability of study data in an excellent study design. Automatic processing and validation controls and data management are just a few aspects that inspire us.

In doing so, we preserve the rights, dignity and safety and ensure the well-being of study participants. At the same time, this enables us to continue working for efficiency and excellence, decent working conditions and improved medical care. The established and certified standards are now being transferred to the next digital decentralized studies for important medical devices. Our high security measures are always risk-based, adapted to the individual requirements of each study and implement the high European requirements for data security and data protection.

Would you like to shape the future of clinical trials? If you want to be part of this scalable development, we offer you the ideal solution for your clinical trial.

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An overview of our current studies can be found here: https://www.mediacc.de/studien/aktuelle-studien-fur-studieninteressierte

Digital elements to reduce stress and relieve caregivers

Bureaucracy and lack of transparency weigh on people in need of care. A representative survey by the SVDGV shows the potential of digital solutions.

The representative survey by the Spitzenverband Digitale Gesundheitsversorgung e.V. (SVDGV) in Germany shows that bureaucracy and non-transparent communication with health insurance companies place a burden on people in need of care and their relatives. The survey of 2500 people, including people in need of care and their relatives, reveals that 60 percent find the bureaucratic effort involved in contact with health insurance companies burdensome, followed closely by a lack of information and advice on care services. This is a dire situation for the weakest in our society.

The survey also shows that many affected people want transparency and information about digital care options. Nevertheless, 44 percent said they did not know what options digital applications offer for assessing care levels. 33 percent of respondents already see the opportunity that digital tools can enable a faster assessment of the level of care and expect that stress with medical services can be reduced through digital applications.

The initiators emphasize the need to implement digital solutions in care in order to make processes more transparent and improve the satisfaction of people in need of care and their relatives. They are calling for specific framework conditions and remuneration regulations to enable the integration of digital care in a timely manner. More information can be found on the SVDGV website.

We are looking forward to the first digital products that scientifically prove the benefits for these vulnerable people.

Practice-oriented medical education to strengthen scientific competence

The Association of Scientific Medical Societies (AWMF) is committed to more intensive teaching of scientific competence in medical studies. Medical students and the AWMF emphasize the need to receive sound scientific education during their studies. Recent surveys show that many students find current scientific education inadequate. The AWMF demands uniform requirements nationwide for teaching scientific competence and underlines the importance of these skills for doctors in various fields of activity. Both medical students and the AWMF welcome the planned reform of medical education, which provides for more intensive scientific education. The Medical Faculty Day (MFT) also supports the demands for increased transfer of scientific competence during studies and sees this as a necessary step to ensure high-quality patient care. The draft of the new medical licensing regulations provides for the preparation of a scientific paper during studies, which is positively received by many students. The AWMF also pleads for clinical research to be recognized as an integral part of continuing medical education. (From German Medical Center 2023; 120 (48): A-2042 /B-1734 by Dr. med. Eva Richter-Kuhlmann)

Green clinical trials: A sustainable case for decentralized digital clinical trials

Digitalization has finally arrived in the heavily regulated field of clinical trials. Decentralized digital clinical trials (DDKT) are revolutionizing how evidence is generated for new medical treatments. Although DDKT is known to be faster, more cost-effective and accessible to more groups of people, there is still skepticism due to the supposed technical complexity. We were able to show a previously unexplored aspect of the digitization of clinical trials: energy and CO₂-Savings compared to traditional studies. We were able to show this in the renowned journal PLOS Digit Health 2 (10).

Traditional clinical trials use significant amounts of paper and energy for forms, questionnaires, visits to study sites, and monitoring visits. The complete digitization of a clinical trial results in a 90.1% reduction in CO compared to a traditional study₂emissions, which corresponds to around 4,399 kg CO2 — or a long-haul flight of 24,000 km (around Berlin — Australia back and forth) — and would require 237 trees to grow for a year to remove this CO₂-Balancing emissions.

The results of our study therefore make it imperative to consider sustainability even when planning and carrying out clinical trials. Depending on the study, complete digitization does not always make sense, but hybrid approaches offer a realistic solution when different degrees of decentralization and digitization are used. Our estimates show that switching to such approaches in around 15,000 clinical trials per year in Europe could potentially save between 41,009 and 65,981 tons of CO₂ would have. Given the EU's goal of becoming climate-neutral by 2050, regulators, politicians, funding agencies, healthcare companies and researchers should intensify joint efforts to safely make this environmentally friendly approach possible.

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Exciting news in healthcare

The planned Health Care Digitalization Act (DigiG) provides for expanding the use of video consultations and televisitation. Until now, video consultations were limited to a maximum of 30 percent of medical services, but this limit is now to be lifted. In future, the remuneration of video consultations will be based on quality features in order to ensure high-quality use, instead of just enabling quantitative expansion. Telemedicine services that integrate structured care processes and are well integrated into other care processes should be paid preferentially. The specific remuneration for teleconsults is determined through negotiations between the Federal Association of Statutory Health Insurance Physicians (KBV) and the National Association of Statutory Health Insurance Funds. The aim of this Act is to strengthen video consultations and teleconsulates as established forms of medical care and to promote their integration into the digital infrastructure, including electronic health records (ePA). It is expected that reports on the use of telemedicine care will be available by June 1, 2024. Stay tuned for more updates on these exciting advancements in healthcare! 💡💻

We're back: Berliner Hoffest 2023

MEDIACC has once again secured a place at the Berlin Court Festival at the Red Town Hall this year. With around 3,500 guests from a wide variety of sectors — sports, business, politics, science, culture and more — this largest Berlin networking event will also be a colorful evening for us and our own guests with exciting conversations and good entertainment!