Read here what moves us at the moment.

Unbeatable together in Berlin

The Special Olympics World Games last weekend once again impressively demonstrated the great potential of exceptional people. Athletes from all over the world came to Berlin with their families and friends to compete and celebrate in a friendly atmosphere. At MEDIACC , we do studies for people who go beyond their limits - for innovations that help special people to make full use of their talents!

AHA against AI use

Last week, we submitted four abstracts to various national and international congresses. We were intrigued that the AHA is one of several institutions that requires authors of scientific papers to disclose the (non-)use of artificial intelligence (AI) and to transparently and explicitly disclose this information in the publication of scientific papers.

MEDIACC stands for the use of human scientific expertise and biological intelligence, taking into account the latest study results, which has so far been possible for AI bots whose function is based on the stochastics of word names.

Full power on Global Running Day

In 2023, MEDIACC once again successfully took part in the Berlin 5x5 team relay. With 2 teams, a total of 10 runners and a lot of moral support, the course through the Tiergarten was completed in sweaty 28 degrees.

The atmosphere was great and the team spirit was palpable, so that it became late for everyone after the joint picnic on the meadow. We look forward to more joint sports events in the future to keep fitness and team spirit high!

Info day: Clinical studies at Leipziger Platz in Berlin

This year's "International Clinical Research Day" will take place on May 20. An information day will be held on Leipziger Platz in Berlin, offering all interested parties the opportunity to find out more about clinical research.

You can find more information about the event here.

Design thinking in the green

Last weekend, the team at MEDIACC did not take any time off: instead, intensive hours of internal process analysis and optimization were on the agenda on Friday and Saturday. Using the "Design Thinking" method, two mixed teams worked on the previously decided topics and compiled their results in presentations with proposed solutions. In order to be able to mentally break away from the established structures, everyone left their familiar surroundings and moved their mental work to the idyllic natural surroundings on the banks of a small lake in the middle of a forest and moor landscape, accompanied only by a rich concert of birdsong. Here, they made the leap from everyday life into the abstract and onto a more distanced level of thinking and evaluation, where processes were discussed, understood and rethought. The team at MEDIACC returned to the beautiful offices with piles of new thoughts and ideas for improving processes - ready to implement the newly gained insights into process optimization suitable for everyday use.

Important for DiGA developers:

The BfArM has published a new version of the DiGA Guideline

The BfArM has published a revised version of the guideline for the fast track procedure for digital health applications (DiGA) according to § 139e SGB V with version 3.2 dated 13.04.2023.

In particular, the chapter on data privacy and data security contains important additions in the new version of the guide with regard to data privacy criteria, the duration of data storage, and the data privacy certificate that will be required in the future. It also explains what kind of digital applications meet the definition of a "DiGA" in terms of combination with hardware or services. For the proof of positive care effects, the updated guideline concretizes the guidance on the validity and consistency of the results, the required prespecification, the robustness of the data, and the requirements for reporting and discussing the results.

The current version of the DiGA guide (version 3.2 of 13.04.2023) is available on the BfArM site: HERE

MEDIACC uses ChatGPT

At MEDIACC GmbH, we use ChatGPT to improve our work in the field of customer-centric solutions for clinical trials in digital health. This technology helps to generate semantically correct texts, automate tasks and perform simple analyses for initial insights. We strive to stay ahead of the curve when it comes to innovation and technology. Our introduction of ChatGPT is just one example of this. We believe it will help us to add value in the market and make complex content simple. Even though we are excited about technologies like ChatGPT, we believe that scientific accuracy is far more important than speed. Good and thorough research is central to our identity. We want to make sure that AI technology is used ethically and that the freedom and individual rights of all participants are safeguarded. Therefore, we carefully monitor all ChatGPT results to ensure accuracy and quality of work. Our team will be fully trained to get the best out of this technology while ensuring ethical and responsible use.

Although this post was written with the help of ChatGPT, we very carefully revised it manually.

New EU Guideline Creates Groundbreaking Perspectives

In March of this year, the European Medicines Agency (EMA) published the groundbreaking guideline on electronic data capture and the use of computer systems in clinical trials. This guideline defines the minimum standards for the use of electronic tools in the context of digital clinical trials. The clear technical requirements and comprehensive regulations, especially for digital signatures (dSignature) and electronic data capture by the patients and subjects themselves (ePROs), are a good basis for us to enable participation for all through innovative digital studies, even independently of doctor's visits, and to be able to conduct clinical studies at all despite the dramatic shortage of personnel in Germany. This groundbreaking guideline opens up new possibilities for the timely conduct of clinical trials with the help of innovative technologies such as wearables, physician video consultations and smartphones.

In addition, the dignity of study participants, their safety and the efficiency of clinical studies are finally formulated in accordance with the current state of the art.

Improved assistance for IVD manufacturers

The MedTech Europe eBook "Clinical Evidence Requirements under EU In Vitro Diagnostics Regulation", published 2/2023, is designed to assist manufacturers with their performance evaluation obligations under the IVD Regulation 2017/746. It provides general updates, practical advice with examples of intended use, including specific medical purpose, scientific validity (definition and evidence), clinical evidence, and benefits and risks of benefits. It calls for scientific rigor through systematic literature review and performance evaluation concepts of equivalence and similarity. It also provides decision support for safety and efficacy of use, considerations for the cyclical nature of product development, and potential benefits of PMPF plans.

The services of MEDIACC are used when clinical studies with the required scientific validity and clinical benefit are required for clinical performance studies according to IVDR 2017/746.

New abstract accepted as presentation in the session "Best paper"!

Digital questionnaires that specifically capture patient-relevant outcomes - so-called patient reported outcome measures (PROMs) - have a high priority in DIGA approval studies. In order to be accepted by the authorities as endpoints, they must be validated according to the latest standards. We have developed and validated such a new digital questionnaire for our client. We are very pleased that this will now be presented at an international congress as a contribution in the session "Best Presentation"!

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