Real time access to digital biomarkers.
Connecting wearable devices and mobile biosensors in hospitals and at home.
Enabling continuous patient monitoring in health care and clinical trials.
Leitwert Clinical Solutions at a glance
Continuous and reliable data collection is a major challenge in the medical field. Wearable devices offer the opportunity to monitor patients continuously and provide deeper insights into patients health status and to capture "real time" Digital Biomarkers. However, the abundance of data obtained through these channels require sophisticated data management and processing tools.
The Leitwert solutions for patient monitoring and clinical trials are built on top of Leitwert’s Device Management Services (DMS) - a secure digital enablement platform - and automate the readout of wearable devices worn by hospitalized patients or patients at home. Automation and device agnosticism renders the system scalable and economically viable. We provide the infrastructure to integrate wearable medical devices and mobile biosensors into the clinical routines in healthcare facilities and at home to increase patient safety and efficiency in patient monitoring and clinical trials.
where ever your patients are
in health centers
Flexible gateway infrastructure allows seamless patient monitoring throughout the clinic.
Plug and play mobile gateways for remote settings transforming any venue into an automated patient monitoring site.
on the road
Leverage mobile phones as gateway and interface for direct interaction with the patients - wherever they are.
Continuous and automated patient monitoring reduces cost through automation while increasing quality (less errors, prevent adverse events, ...) by leveraging better data.
Timely information on changes in patients health conditions allow preventive and fast interventions resulting in reduced average length of stay - both in ICU and hospitalized patients. Seamless elongation to remote monitoring in home care settings allows to monitor while it makes sense from a clinical point of view and stay in close dialogue with your patients also after they have been discharged.
Future-prove your organisation through this revolutionary approach that comes with various "collateral benefits" like preventing vendor lock-in due to device agnostic and open system design or systematic aggregation and full control over clinical and process data. This is the foundation to become a data driven health organization.
Not to forget various benefits on patient side like reduced number of necessary follow-up visits and peace of mind also after submission.
We add objective measures from medical sensors to the patient reported outcome in clinical trials - during the development and validation of new therapies or digital biomarkers or the validation of revolutionary medical devices. Our common, ultimate goal is to improve clinical outcomes and the quality of life. Collecting also real world or real life data within patients' natural habitat has significant advantages compared to relying only on data that is captured in artificial laboratory environments (e.g. gait pattern at home vs. in a gait laboratory). Running your clinical trials decentralized over multiple centers is facilitated through the decentralized architecture and control over data (compared to device manufacturer cloud). Leitwert’s solution can be plugged into your trusted (GCP compliant) EDC systems to enhance and complement form based data capturing with digital sensor data.
From reducing the need for follow-up visits, over process automation with the aim to reduce participant's burden while using the convenience of modern wearable sensors, digital technologies are not only facilitate the recruitment and compliance in clinical trials, they are ready to revolutionize evidence based medicine.
Improve and automate patient monitoring in hospitals, rehabilitation centers, nursing homes and assisted living settings. Monitoring hospitalized patients is a key duty in health centers. In many cases this is still done manually (e.g. nursing staff measures vital signs every few hours). This is error prone, inconvenient for patients, cumbersome for the staff and the data output is relatively poor (a few data points per day).
Modern medical grade wearable biosensors offer continuous and automated data aggregation while increasing convenience for the patient. Such a systematic collection of vital signs is the basic for computer assisted patient monitoring. Using frameworks like Early Warning Scores (EWS) have the potential to successfully prevent adverse events trough timely intervention. This offers potential to reduce the average length of stay in hospitals (and ICUs).
- Centralized device management - centralized device management for efficient operations.
- Device agnostic and open - no vendor lock in.
- Open and flexible API - integrates with existing hospital IT infrastructure.
- Patient and user centric design - designed with and for the users and patients - highest usability and applicability in the clinical environment while enhancing patients compliance behavior .
patient at home
We believe that patient monitoring should end or be interrupted when it makes sense from a clinical point of view and not just because a patient is transferred or discharged. Our system enables seamless remote patient monitoring with automated data capturing using gateways which work plug and play.
Remote monitoring is a game changer in health care. Reducing patient burden trough convenience while increasing patient sa key driver within a patient-centric model. It enables a longitudinal expansion along the patient's value chain for health centers and to provide secure access to healt technology assessment (HTA) relevant "real world" captured data for all stakeholders. This is increasingly important to service today's multi-professional treatment concepts (all the way from primary care physicians, specialist, physiotherapist etc.). We believe data discontinuity should be something of the past. Remote monitoring and tele-health also hold the potential to significantly improve cost and outcome. Benefitting patients (receivers), clinicians, medical personnel (providers) and the whole economy (payers), digital transformation will challenge the industry to reinvent their business models as a service oriented one.
- Seamless monitoring - better access to healthcare for patients.
- More and better "real world" data points, HTA-trustworthy, statistically and clinically validated data - improved quality of care.
- Patients are not left on their own - peace of mind and daily assurance for patients.
- Improved support, education and feedback - increases patient engagement.
- Increases bandwidth - increased efficiency allows to serve more patients.
- Allows to deliver higher-quality of care to more patients while reducing risks - increases efficiency and reduces cost.
Are you currently using or planning to use wearable devices and biosensors to develop objective digital outcome measures or digital biomarkers? Or are you advancing the “state-of-the-art” in the field of patient monitoring with the use of biosensors? If so, we are eager to contribute and support your visionary projects! Our system removes the technical hassle from using devices in research and clinical trials. Get in touch to discuss your project!
- Reliable data collection infrastructure ready to use - prevents data loss and helps to start collecting data faster.
- Powerful API and flexible databases - facilitates systematic storage of data and provides convenient access for analytics and evaluations.
- Transparency and thorough traceability through automated metadata documentation - supports the documentation process and the reproducibility of your experiments.
Learn why we do this?
We provide real time access to digital biomarkers and real world data for CROs, Medical Device companies and Pharmaceutical companies. Our system solution integrates with your favorite EDC system. Get in touch with us to discuss how wearable devices and mobile biosensors help improving your clinical trials.
- Objectification of outcomes - less follow up visits, automated data capturing.
- Collect continuous data in patient's real-world environment (e.g. at home)) - complement or substitute data captured in the laboratory.
- Increase and monitor patient compliance - and access data in real time.
- Less follow up visits, automated data capturing - reduce cost.
- Facilitate Recruitment of Participants - by lowering hurdles and increasing the convenience for the participants.
- Improve Data Quality - continuous data.
- Increase and monitor patient compliance - promotes timely intervention instead of participants exclusion.
We are looking to collaborate with manufacturers of medical devices as integration partner in hospitals and digital health systems.
We also collaborate with device manufacturers as technology partner e.g. to enhance your devices or health apps with a medical cloud (white lable possible). Learn more about device fleet management and secure updates and connectivity infrastructure and server backend for your devices and mobile apps. We also support you in the development of new devices, especially if you are looking for reliable low power fimrware which is available within very short time and reduces maintenance to a minimum grace to our embedded development framework ConcerRTOS.
distributors and partners
Are you a distributor? Do you offer complementary services and solutions? Are you a medical device manufacturer? Do you provide analytical services for clinical data? We strongly believe in collaboration and co-creation. We are your best-in-class partner for real-word medical data streaming and management. Get in touch with us now.
how it works
We strongly believe in using the best tool for the task. Therefore our system is device agnostic and open allowing to easily integrate any 3rd party devices with accessible API. Whenever there is a new use case, it can be integrated - increasing the value of the clinical IT infrastructure over time.
For patients or trial participants wearable devices offer unprecedented convenience trough wireless data transfer, small size and high wearing comfort. This grants full mobility and reduces patient burden to the minimum.
For health care centers this enables a centralized patient and device management and direct access and control over the collected data while preventing vendor lock-in trough a device agnostic infrastructure.
For device manufacturers our system significantly lowers the barrier to integrate their solutions into health centers. Both devices and analytics services.
Synchronizing device data with no user interaction needed guarantees highest possible data availability. Whenever a device is within reach of a wireless gateway a connection is automatically established and data is synchronized. This offers the best possible trade-off between data availability and mobility of the patients. If a device is out of reach, the data can be buffered in the internal device memory giving people maximum freedom and flexibility without compromising data consistency and continuity.
Our gateway technology is extremely reliable and resilient by design. The stateless gateways can be pre-configured to work plug and play. They can be deployed in fix installations or used as mobile devices which can be plugged anywhere. The gateways efficiently collect data from wireless devices, automatically synchronize device time and settings and can also be used to roll out firmware updates to the devices if desired. The gateways themselves are coordinated by the server and are also managed as devices via server and a dedicated GUI.
The device management server (DMS) coordinates all devices in the field and securely saves acquired data in a database. It provides a granular permission system to manage access rights of human and machine users. With an immutable audit trail and configurable approval workflows the system can be customized to the requirements of the specific applications to comply with relevant regulations (e.g. GCP, HIPAA, FDA 21 CFR Part11, ISO 13485, ...).
We believe software must be flexible to fit the needs of the task at hand – that is why the server software is designed for flexibility and adaptability. Both front and backend exhibit, modular architecture and are composed of different components which can be selected for the specific use cases (e.g. patient management, device management, interactive data viewer, dashboards, live processing pipelines for incoming data, ...). If needed, custom functionality can be added by creating and plugging custom components. Automated server monitoring guarantees highest availability and fast response time in case of an incident. Where needed redundant architectures can be deployed.
Data integrity and data security are of uttermost importance. To make sure you are in full control of the data at any given point of time, our system can be deployed on premise inside your secure IT infrastructure (e.g. in a hospital). This enables the system to comply with local data protection laws and does not require you to send your patient data to some 3rd data clouds abroad.
Per default the incoming data is stored in NoSQL databases which enables to handle large amounts of incoming streaming data and to capture data streams with high temporal resolutions. However, the system can also just forward the data (if desired after automated data normalisation steps) to another database e.g. in a local data warehouse or to patient files in an electronic patient record.
We believe collaboration and co-creation is a powerful driver for innovation. To get there, good communication is inevitable. We think this is especially true for machines. This is why we dedicate highest diligence to the design and maintenance of the interfaces of our tools .
Sticking to using the best tool for the task our system provides the freedom to data scientists and organisations to use their preferred analytics tools and data processing pipelines. The API also enables seamless integrations with existing infrastructures or 3rd party analytics services.
custom front ends
Display the relevant information to the right people at the right moment in comprehensive and intuitive manner. That is the pattern that turns information into actionable insights.
Customize the relevant views and dashboards to fit your workflows with our modular front end application. Different people have different roles and need to perform different tasks - therefore we offer user group specific front ends. Be it for practitioners (e.g. overviews of the patients they take care of, patient dashboards for ward rounds, team reports for shift changes etc.), for nursing staff (e.g. ward dashboards which can be displayed on centralized screens or accessed via tablets) or for device managers and IT, management and if desired also for patients and their families. We make it happen.
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