We digitalize health care.
Medical data automation for
Our focus: The digitalization of the health care sector
Cloud-based software for:
Effective management of pivotal and postmarked (PMS/PMCF) studies
Automatic capture of clinical data (PROMs, PREMs), including AI image data analysis
Clinical trial management system with many automation functions
The analysis of large health data sets has the potential to advance patient-centered care significantly. It can also be used to manage the regulatory requirements for medical technology and pharmaceuticals in the area of clinical studies and trials more efficiently.
As a driver of innovation in the fields of AI and medical data management, we are focused on the digitalization, utilization and data-based automation of processes in the health care sector.
Digitalization for doctors and clinics
Medical software for the automation of administrative processes of data capture in hospitals
Hospitals generate vast amounts of medical and clinical data every day. However, many hospitals cannot easily share data between different systems. Since manual data transfer is very time-consuming and cost-intensive, important data frequently remain unused after being captured and are not available for further treatment or research.
The interoperable use of these data sets offers great potential for intelligent, patient-centered health care:
- Interoperable use of patient data
- Relief of time and personnel-intensive routine processes
- Cross-sector data utilization
- Measurement and optimization of quality of clinical care
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Forwarding of data internally and externally
(e.g., to medical registers)
Application software for health care facilities
Patient-oriented and interoperable
With the UNITY OUTCOME and RayView modules, the capture of clinical data, PROMs and AI-supported analysis of medical image data are optimally integrated into existing workflows.
UNITY OUTCOME
for optimized survey of patients
UNITY OUTCOME with RayView
AI-supported analysis of medical data
Application software for health care facilities
Patient-oriented and interoperable
With the UNITY OUTCOME and RayView modules, the capture of clinical data, PROMs and AI-supported analysis of medical image data are optimally integrated into existing workflows.
UNITY OUTCOME
for optimized survey of patients
UNITY OUTCOME mit RayView
AI-supported analysis of medical data
Learn more about UNITY OUTCOME/RayView:
Challenges for medical technology and pharmaceutical companies in clinical trial management
Medical devices must fulfil stringent regulatory requirements
Medical technology companies are required by law to conduct clinical evaluations of their medical devices. Verification of the basic safety and performance requirements must be provided both at the time of approval and throughout the life cycle of a medical device (PMCF).
Thus, a large amount of clinical data are required for verification, imposing a high administrative burden.
For medical devices, these data must be generated in a clinical trial “undertaken to assess the safety or performance of a device” (Art. 2, Para. 45 of the MDR). This presents a major challenge for manufacturers in the medical technology industry.
Efficient study management for medical technology companies
- Reduces the effort and costs of approval and post-market (PMCF) studies
- Optimizes the management and analysis of medical and clinical data, image data (MRI, CT and X-ray) and PROMs
- Complies with regulatory requirements such as MDR, GDPR, ISO 13485, HIPAA, 21 CFR Part 11, 21 CFR Part 820 and IEC 62304
Intelligent clinical trial management with UNITY Research from RAYLYTIC
Clinical study management: Scientific and cloud-based
UNITY Research provides the ideal platform for effective study management that meets regulatory requirements and provides an overview of all study-related data in real time.
UNITY Research integrates the capture of clinical data and PROMs into everyday clinical practice and automates processes in study management as well as in data capture and analysis.
With RayView, we offer you the additional capability of automated analysis of radiographic image data specifically for clinical studies and trials in orthopedics.
UNITY Research
for effective study management
Intelligent clinical trial management with UNITY Research from RAYLYTIC
Clinical study management: Scientific and cloud-based
UNITY Research provides the ideal platform for effective study management that meets regulatory requirements and provides an overview of all study-related data in real time.
UNITY Research integrates the capture of clinical data and PROMs into everyday clinical practice and automates processes in study management as well as in data capture and analysis.
With RayView, we offer you the additional capability of automated analysis of radiographic image data specifically for clinical studies and trials in orthopedics.
UNITY Research
for effective study management
Learn more about UNITY Research with RayView:
UNITY Research supports CROs and study centers in clinical trials
Secure access to interoperable medical and clinical data
The regulatory requirements of the EU-MDR make study management much more complicated for CROs and study centers. For example, the implementation of approval and postmarket (PMCF) studies is not only more strictly regulated, but the provisions regarding the quality of study results have also been tightened. Conducting studies requires that patients must be able to share their medical data while complying with data protection requirements.
Thus, patient-related medical and clinical data must be collected, structured and evaluated before and in some cases for a long time after treatment. Sponsors expect the highest degree of transparency and clarity. Limited availability of personnel and high cost pressure in the procurement and maintenance of IT systems and the use of partially outdated software lead to a backlog in investments.
For CROs and study centers, this means that planning, implementing and evaluating clinical studies is an enormous challenge without maintenance-free, always up-to-date, cloud-based software.
Study management with UNITY Research:
- Relieves your employees of tiresome routine tasks
- Simplifies the overview of study-related results
- Improves your communication with clinics and sponsors
- Impresses your sponsors by the excellent implementation of studies
Digital solutions for CROs and study centers
Representation in real-time. Cloud-based. Automated.
UNITY Studies gives you real-time 360° overview of all data of your clinical studies and trials at any time. This enables immediate recognition and intervention in case of error-prone routine tasks (protocol deviations, laboratory value forgotten, image taken at the wrong time, etc.).
The result is a much faster, more efficient and more transparent implementation of study processes.
UNITY Research
for automated implementation of studies
Learn more about interoperability, data management and automation as guarantees of success:
