Read here what moves us at the moment.

🎉 Great news from MEDIACC for clinical trials! 🎉

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We are pleased to announce that our Information Security Management System (ISMS) has once again been successfully recertified. This is a significant milestone that underlines the strength of our commitment to the highest standards of security and data protection in the conduct of fully digital clinical trials.

Our renewed ISMS recertification guarantees that we protect the integrity and confidentiality of all the data we manage at the highest level. Our patients' sensitive information is in safe hands and digital platforms. This ensures the efficiency and reliability of our digital study processes and a working environment built on trust and security. We continuously invest in technology and training to ensure that our team is at the forefront of secure data handling and protection procedures in this highly regulated field.

We are proud of our team and partners who work tirelessly to ensure that our systems and processes meet stringent security requirements. This success reaffirms our commitment to excellence in all aspects of our work in a forward-thinking, secure and dynamic environment.

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 used the unique opportunity for a personal exchange with a wide range of national and international companies.

Our aim is to constantly and continuously improve our digital, decentralized clinical trials and keep pace with innovations. Our visit to the DMEA provided the perfect platform for this: we held ground-breaking and intensive discussions with suppliers, manufacturers of market-oriented products, potential partners and customers as well as "old hands" and are returning to the office full of exciting visions.

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

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We are pleased for our customer about the positive evaluation of the AFORCE-1 study by the Colorectal Cancer Study Board of the German Cancer Society! Since April 5, 2024, the study on early cancer detection using a new blood test has been listed in the StudyBox under the 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, making it more attractive for our test centers in the Berlin area.

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

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In its current and third DiGA report, the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) takes stock of the provision of digital health applications (DiGA). Stefanie Stoff-Ahnis, Director of the National Association of Statutory Health Insurance Funds, calls for equal treatment with other services reimbursed by the statutory health insurance funds. Only the "potential" of medical benefit is conceded to the DiGA in the case of "low access requirements for DiGA when proving their benefit" and insufficient "cost-effectiveness".

These statements are an affront to the companies that seriously and with great effort undergo a very complex process for innovative therapies. The same applies to those responsible at the Federal Office for Drugs and Medical Devices (BfArM), who interpret the legal framework in such a way that even for the provisional inclusion of a DiGA in the so-called DiGA directory, higher standards of study quality and scientific evidence are required than those for currently reimbursed medical devices, e.g. in the GKV-Spitzenverband's list of medical aids, or than has ever been the case for known useless therapies.

This undifferentiated and unbalanced presentation, which has been picked up by the press, not only harms manufacturers, but also all patients by preventing real innovation. Instead, the same requirements for scientific evidence should apply to all treatment options and fair payments for all services and to all service providers in this country should be thought through and implemented on the basis of facts.

Fully digital clinical trials at MEDIACC: innovative, efficient and people-oriented thanks to cutting-edge technology

MEDIACC defines the future of digital clinical trials by practically implementing international laws and recommendations, in particular the EMA guideline on computerized systems for clinical trials.

In a lighthouse project, we successfully conducted a completely digital study in which over 2000 study participants were recruited to test an innovative health app via a telemedicine approach. The digital study platform integrates an electronic data capture (EDC) system with other digital modules and newly designed 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 some of the aspects that inspire us.

In this way, we safeguard the rights, dignity and safety and ensure the well-being of study participants. At the same time, this enables us to continue our commitment to efficiency and excellence, humane working conditions and improved medical care. In the meantime, the established and certified standards are being transferred to the next digital decentralized studies for important medical products. 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.

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

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You can find an overview of our current studies here: https://www.mediacc.de/studies/current-studies-for-interested-students

Digital elements to reduce stress and relieve caregivers

Bureaucracy and a lack of transparency are a burden for those in need of care. A representative survey by the SVDGV shows the potential of digital solutions.

The representative survey conducted by the German Association for Digital Healthcare (SVDGV) shows that bureaucracy and non-transparent communication with health insurance companies are a burden for people in need of care and their relatives. The survey of 2,500 people, including those in need of care and their relatives, reveals that 60 percent find the bureaucratic effort involved in contacting health insurance companies a burden, closely followed by a lack of information and advice on care services. This is a desolate state of affairs for the weakest members of our society.

The survey also shows that many of those affected would like transparency and information about digital care options. Nevertheless, 44 percent stated that they do not know what options digital applications offer for care level assessment. Already, 33% of respondents see the opportunity that digital tools can enable a faster assessment of the care level and expect that stress with the medical service 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 those in need of care and their relatives. They are calling for concrete 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.

Practical training in medicine to strengthen scientific expertise

The Association of the Scientific Medical Societies in Germany (AWMF) advocates more intensive teaching of scientific skills in medical studies. Medical students and the AWMF emphasize the need to receive a sound scientific education during their studies. Current surveys show that many students feel that the current scientific training is inadequate. The AWMF is calling for uniform nationwide standards for the teaching of scientific skills and emphasizes the importance of these skills for doctors in various fields of activity. Both medical students and the AWMF welcome the planned reform of medical studies, which provides for more intensive scientific training. The Association of Medical Faculties (MFT) also supports the calls for more scientific skills to be taught during medical studies and sees this as a necessary step towards ensuring high-quality patient care. The draft of the new medical licensing regulations provides for the preparation of a scientific paper during the course, which is welcomed by many students. The AWMF also calls for clinical research to be recognized as an integral part of medical training. (From Dtsch Arztebl 2023; 120(48): A-2042 /B-1734 by Dr. med. Eva Richter-Kuhlmann)

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

Digitalization has finally arrived in the highly regulated field of clinical trials. Decentralized digital clinical trials (DDCTs) are revolutionizing how evidence is generated for new medical treatments. Although DDCTs are known to be faster, more cost-effective and accessible to more groups of people, skepticism remains due to the perceived technical complexity. We were able to show a previously unexplored aspect of the digitalization of clinical trials: the energy and_{CO2 savings} compared to traditional trials. We were able to show this in the prestigious journal PLOS Digit Health 2(10).

Traditional clinical trials consume significant amounts of paper and energy for forms, questionnaires, visits to study centers and monitoring visits. The complete digitization of a clinical trial leads to a 90.1% reduction in_{CO2 emissions} compared to a traditional trial, which is equivalent to about 4,399 kg of CO2 - or a long-distance flight of 24,000 km (approximately Berlin - Australia round trip) - and would require 237 trees to grow for one year to offset this_{CO2 emission}.

The results of our study therefore also make it imperative to consider sustainability when planning and conducting clinical trials. Complete digitization does not always appear to make sense depending on the study, but hybrid approaches offer a realistic solution if different degrees of decentralization and digitization are used. Our estimates show that switching to such approaches would potentially save between 41,009 and 65,981 tons of_CO2 for around 15,000 clinical trials per year in Europe. Given the EU's goal to become climate neutral by 2050, it is important for regulators, policymakers, funders, healthcare companies and researchers to step up joint efforts to safely enable this environmentally friendly approach.

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Exciting news in the healthcare sector

The planned law on the digitalization of the healthcare system (DigiG) provides for the use of video consultations and televisits to be expanded. Previously, 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 criteria in order to ensure high-quality use instead of just allowing a quantitative expansion. Telemedicine services that integrate structured care processes and are well integrated into the other care processes are to be remunerated preferentially. The specific remuneration for teleconsultations will be determined by negotiations between the National Association of Statutory Health Insurance Physicians (KBV) and the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband). The aim of this law is to strengthen video consultations and teleconsultations as established forms of medical care and to promote their integration into the digital infrastructure, including the electronic patient file (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 advances in healthcare! 💡💻

We are back again: Berlin Hoffest 2023

MEDIACC has once again secured a place at this year's Berlin Court Festival at Rotes Rathaus. With around 3,500 guests from a wide variety of fields - sport, business, politics, science, culture and more - this largest networking event in Berlin will also be a colorful evening with exciting conversations and good entertainment for us and our own guests!