Anna ChiwonaThe digitalization of the healthcare sector is unfolding on multiple levels. It encompasses not only the enhancement of workflow processes and the establishment of data transfer standards but also innovations in digital medical products, including, for instance, apps for patients with heart failure or Parkinson’s disease. Furthermore, this transformation extends to the research infrastructure (find out more about digital, decentralized trials) alongside market access and regulatory frameworks.
DTx Research Solutions is a young company, founded in August 2024, specializing in comprehensive services for conducting decentralized clinical studies. In cooperation with the Mobile Health Lab, DTx Research Solutions has created a tailored study service specifically designed for conducting trials of digital therapeutics (DTs). The Mobile Health Lab supported this initiative by developing and providing a fully digital study management platform, the DigitalTrialManager (DTM), based on DPM.research. Together, they just successfully participated in the start-up funding program at AHEAD, Fraunhofer’s Deeptech Incubator. We spoke to the founders of DTx Research Solutions, Ann-Kathrin Spörlein, Cordula Forster, and Till Gladow.
You describe yourselves as a “digital CRO”. What does that mean and exactly does DTx Research do?
Ann-Kathrin: We are a specialized digital contract research organization focused on helping manufacturers of digital therapeutics with the planning, execution, and evaluation of clinical studies for their digital health solutions. Our main goal is to digitize clinical research processes as much as possible, making the studies required for market approval more efficient, patient-friendly, and scalable. Therefore, we leverage innovative technologies, such as the study platform DTM, to speed up the study processes while ensuring high data quality through real-time data collection and effective monitoring. Our clients are supported throughout the entire process – from strategic study planning and regulatory consulting to participant recruitment, data management, monitoring, and scientific evaluation and analysis, all the way to publishing study results.
The way to market approval for a digital medical product is highly regulated and requires robust evidence, which means you need a very well-planned clinical study.
Walk us through the process: As a start-up, I would like to launch a digital medical product on the market, but I still need to conduct a study to prove its effectiveness. What do I need to be aware of, in your experience? And why should I turn to you as a digital CRO?
Ann-Kathrin: As a start-up or manufacturer in general, you first have to know which route to market approval or remuneration you want to take. Then, depending on what you decide on, specific but also different requirements are placed on the demonstration of evidence. Generally speaking, the way to market approval for a digital medical product is highly regulated and requires robust evidence. As a manufacturer, you have to be aware that this is not only very complex, but also resource-intensive, and that certain steps in this entire process should not and must not be carried out in-house. Therefore, manufacturers should define study-specific requirements at an early stage, and then the appropriate study design must be selected and properly planned. This also includes efficient patient recruitment, the definition of the respective endpoints, but also the form of data collection to ensure data quality. Digital and decentralized study formats offer the potential to do just that. As a CRO, we combine scientific and regulatory expertise with modern digital solutions. Our digital study model, including the platform that we have together with Fraunhofer IIS, enables the flexible, patient-centered, and efficient implementation of studies.
What were the main goals and steps in the development of your service and MHL’s DigitalTrialManager?
Cordula: Because we work with start-ups, our goal is to enable efficient, cost-effective study implementation. Financing conventional studies with traditional trial centers is very cost-intensive, and the processes are also very time-consuming. Recruitment in particular is a major problem because study centers are regionally limited. This is something we can improve with our digital processes, enabling us to recruit patients across Germany. At the same time, are committed to ensuring that all regulatory requirements are met. That’s why we developed a platform that fulfills all regulatory needs while remaining user-friendly for our study personnel, intuitive for the medical staff, and easy and simple to use for the patients. The platform also maps all the steps necessary in a study: from video consultations to patient information and e-consent, as well as data entry and analysis.
That was actually a first step in designing the platform with the Mobile Health Lab team. We asked ourselves: Which steps are there in trials, which ones need to be mapped digitally, and how map them to ensure compliance with regulatory requirements? Data protection is critical issue – with regard to video consultations, the e-consent, and data storage on secure servers. Having a close exchange with Fraunhofer is an asset for us, enabling us to swiftly adapt and enhance our solution as needed.
© DTx Research Solutions
As a young company with many years of individual experience in the market entry of medical products, how else has your collaboration with IIS been beneficial?
Cordula: We do have many years of experience in study preparation, conceptual design, management, and implementation. But we don’t have the technical expertise that the Fraunhofer Mobile Health lab has. They bring a know-how in technical implementation and programming that we cannot provide ourselves. This is why it’s beneficial to have a partner who offers valuable support and extensive experience. Plus, the Mobile Health Lab team has experience in conducting clinical trials, so we have a common understanding of what is required and what needs to be implemented. No single study is like another. Together, we can configure processes quickly and customize the trail manager.
Digital health applications will become a standard in patient care. But only with solid, scientifically backed evidence can we gain the trust of patients and doctors to eventually bring these products to market.
How are the needs of the various stakeholders taken into account and what distinguishes you and the platform from other study management systems and CROs?
Till: Let me start with the manufacturers. Manufacturers of digital medical devices need to provide proof of efficacy. It makes sense to obtain this digital proof in the target environment of the product, for instance in patients’ everyday lives if the digital medical device addresses their everyday life. Naturally, manufacturers want to conduct studies as quickly and cost-effectively as possible. Our approach focuses on reducing certain expenses during the study to help save costs. On the medical side, it’s a plus that we are involving doctors who can work independently on the side, regardless of time and location. Patients, on the other hand, no longer need to travel to study centers, which saves them time and money. Ultimately, they can participate in a study from the comfort of their everyday lives.
What sets us apart from other CROs is our specialization in digital medical devices and the study design for these products. This is still a relatively new industry, so, with our experience, we have had a head start: We know the requirements for studies with digital medical devices very well and DPM, unlike other study management systems, can tailor the processes individually to each study’s workflows and quickly build and adjust individual designs.
How do you see developments in the industry in the next 5-10 years? Are further developments of your services and the platform planned for the future?
Till: After the implementation of the Digital Healthcare Act, there was a certain hype in the industry surrounding digital health applications. Now, this sector is consolidating and becoming more professional. The entry of large companies and big pharmaceutical firms into the digital health application business also shows that there is trust in the industry. I am convinced that digital health applications will become a standard in patient care. But only with solid, scientifically backed evidence can we gain the trust of patients and doctors to eventually bring these products to market. Since we are at the beginning of a process, the needs and requirements for clinical studies will continue to grow.
Thank you, Ann-Kathrin, Cordula, and Till for the interview. We wish good luck for your future developments and in the AHEAD program!
Featured Image: Fraunhofer IIS
Georg Zweyer
Georg Wieland
Nadine Lang-Richter
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