MEDIKURA is shaping the future of precision medicine.

MEDIKURA is shaping the future of precision medicine.

By Dr. Friderike Bruchmann
28.12.2020

From nebenwirkungen.de to the leading drug safety reporting platform – how we are equipping evidence-based medicine and application-accompanying data collection for the future. What is the role of ImpactMonitor and how are we influencing digital health as well as the precision medicine of tomorrow? What benchmarks are we setting through technologization and digitization of reporting pathways?

Real-world evidence platform for drug efficacy and drug safety.

MEDIKURA aims to create the leading reporting platform for generating real-world evidence (RWE) for drug efficacy and drug safety. To reach that goal in the near future we have created an innovative, multi-directional communication platform that unites consumers, physicians, pharmacists and manufacturers. This allows the systematic sharing of relevant information on drug efficacy and safety in the real world. The data we collect is made available in a standardized and structured way to various healthcare stakeholders, such as doctors and pharmacists. The goal is to provide a larger database, based on real-world care settings, for increasingly personalized drug prescriptions. Especially in the case of new active ingredients with accelerated market approval, the application-accompanying data collection upon marketing authorization is indispensable. Therefore benefit and tolerability can be monitored in real time and further evidence can be generated.

Medikura – the leading drug safety reporting platform

After nearly 2 years of development, we are the leading reporting platform for patient adverse events. Our new reporting tool sets the standard for direct, digital and time-saving communication, between all parties involved in the reporting process. With a market share of currently approx. 30% of all spontaneous reports, more than 2000 patients entrust us with their drug experiences every month. In accordance with international pharmacovigilance guidelines, we forward these pseudonymous reports, i.e. without disclosing the personal identity, to the responsible manufacturers for further processing. Our collected reports are currently already being processed by over 400 manufacturers. More than 70 of these are registered with us for further functions. This is where the great advantages of our reporting platform become apparent, because more than 30% of the collected reports receive queries from the manufacturers. Also, the feedback rate from patients is 60%. Due to the simplicity and automation of digital communication, cases are closed after 72 hours at the latest. In accordance with legal requirements, the manufacturers then forward the reports to the European Medicines Agency. This is followed by an evaluation by the risk committee. Our innovative communication platform is seamlessly integrated into the existing legal monitoring system for drug safety throughout the entire process. We place particular emphasis on the redesign of pharmacovigilance, in terms of digitalization and user orientation. This is another reason why we offer our platform technology as a software-as-a-service solution. Pharmaceutical companies can thus use internal, proprietary reporting channels, e.g. their website, social media channels, input by field staff or call centres. Up to 95% time savings are possible by digitizing and automating PV processes.

Expansion of the platform to include additional drug efficacy recording.

Our platform technology and partner network have now reached a level of maturity where we are evolving from a reporting platform for side effects to a real-world evidence platform. In addition to the recording of side effects, the focus is now also on the monitoring of the efficacy of drug therapies. In collaboration with leading researchers, we are applying standardized measurement tools for recording Patient Reported Outcomes (PRO). Our web platform aims at collecting thousands of consumer experiences in a structured way in order to create personalized risk-benefit profiles to support drug prescription. Additionally, clues for novel therapies and drug development are released. The findings can be further used for comparison with those from clinical trials. 

The possibilities going to be offered by our RWE platform are limitless: e.g. we enable the integration of telemedicine services to consult with medical experts. In addition, simple and secure communication channels can become available between manufacturers and consumers to answer medical inquiries. Safety-relevant information can also be requested via this channel. 

Our web application can be used flexibly, among other things as a white label solution, for manufacturers‘ own product launches, such as new active ingredient approvals in the population. With the so-called ImpactMonitor patients can digitally record their therapy progress with regard to efficacy and side effects. For this purpose, patient-specific characteristics such as age, gender, state of health, medications, concomitant diseases and data relevant to everyday life on quality of life are collected. The ImpactMonitor is characterized by a quickly available, structured data. In addition, it offers many new possibilities for health technology assessment. Compared to the data collection of the past, the ImpactMonitor collects high-quality data in a very short time and at a much lower cost.

MEDIKURA shapes the future of drug safety 4.0

After our market entry with nebenwirkungen.de, it is now time to fully realize our vision of a reporting platform for drug efficacy and safety. Data security, data quality and the protection of consumers‘ personal data are particularly important to us. Real-time data transfer, user-friendliness and customizable software solutions are our tools to establish real-world evidence for the efficacy and safety of drug therapies. Our goal is to ensure that every patient receives the best available drug therapy at any given time.

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