UNITY
RAYLYTIC ─ Experts in orthopedic trials
With over 100 clinical studies – post-market surveillance, IDE, registries and research – conducted in Europe and the US, we offer in depth knowledge and insight into clinical trial management, medical imaging and the collection and analysis of medical data with a specialization in orthopedics.
As an experienced imaging core lab, we provide highly precise and independent analysis of medical images using validated image processing algorithms based on artificial intelligence (AI).
We are active in research, offer clinical expertise, are leading advancements in imaging analysis and have a deep understanding of current regulatory and data protection requirements as well as trends in healthcare.
RAYLYTIC is an ISO 13485 certified developer of medical software with a 21 CFR Part 11-compliant clinical trial management software.
UNITY ─ More than an EDC System
The fundamental difference between UNITY and conventional electronic data capture (EDC) systems is that it combines the efficient collection and AI-based analysis of medical data, such as patient reported outcomes (PROMs), case report forms (CRFs) and medical images (CT, MRI, X-ray), in one system.
With UNITY, the planning and monitoring of clinical trials or post-market studies can be performed in a cost-effective, transparent and efficient manner while involving all stakeholders via the same platform.
UNITY automates error-prone routine tasks and collects data for targeted and measurable process optimization.
AI-supported image data analysis
The various AI-based modules for image analysis integrated in UNITY enable an objective, reliable and highly precise analysis of radiographic parameters for the quantitative and qualitative assessment of implant performance.
Owing to the superior precision, meaningful conclusions can be drawn even from smaller patient cohorts, thereby significantly reducing study related costs.
Our range of motion (ROM) measurements, for example, are 15 times more accurate compared to manual measurements by experienced physicians (Schulze et al., J Biomech, 2011).
We offer automated assessment of a wide range of morphological and geometric parameters, such as:
- range of motion
- disc height
- sagittal balance (pelvic incidence, sacral slope, pelvic tilt, etc.)
- fusion
- loss of correction
- center of rotation
- implant migration/subsidence
- AP instability
- disc/vertebral body height
- prosthetic wear (with µm accuracy)
State-of-the-art clinical trial management
While many clinical studies have basic similarities, others are extremely specific with highly individual requirements. Clinical studies in orthopedics, e.g., spine trials, are particularly demanding with regard to data collection and analysis as they often include the assessment of several indexes and adjacent spine levels.
Our highly flexible database design and electronic data management system can be adapted precisely to your requirements.
With over 150 radiographic parameters already predefined in the system and an integrated network of experienced radiologists and orthopedic surgeons, we offer a full-service package to guarantee the success of your multi-center clinical trials and research studies.
Selected features of UNITY’s clinical trial management module:
- easy study definition via drag & drop
- dashboards with overviews of existing and missing data
- browser-based, robust transmission of image data, incl. GDPR-compliant automatic anonymization prior to transfer and storage
- trial-specific creation of radiography protocols, recording instructions and data exchange protocols
- extensive data analysis and data export functions
- real-time validation and edit checks
- mid-study changes to accommodate protocol amendments
- remote-monitoring and granular user access rights
- assistance in less than 30 minutes during business hours
- ongoing support to the central study and data entry teams
Electronic collection of PROMs & CRFs
Replacing error-prone, paper-based methods with an EDC system not only boosts engagement and compliance, it also increases the efficiency of your studies and reduces study related costs. By enabling their precise documentation, efficient execution, real-time visualization and statistical analysis, UNITY automates and objectifies the collection of PROMs and CRFs.
UNITY is hardware-independent and browser-based and can be used on tablets, terminals or desktop PCs directly by the patient or in interview mode. UNITY can be used outside of scheduled clinic visits to collect data from patients, enabling surgeons to remotely track their patients’ real-time healing progress and satisfaction levels.
Selected features of UNITY’s EDC module:
- accessible from anywhere, at any time
- various validated, multilingual questionnaires
- easily definable individual questionnaires
- unscheduled questionnaires
- automated scoring with respect to subgroups or dimensions
- immediate input validation for plausibility
- consideration of different units (international users or studies)
- real-time reporting and graphic visualization (patient vs. cohort over time)
- configurable alerts for specific responses or unexpected deviations (risk-based monitoring)
- rule-based routines for automated data validation
Increase the efficiency of your clinical trials while facilitating the generation of high-quality and reliable data, correspondent to the increasing regulatory requirements related to the new EU-MDR. Entrust your data with a leader in orthopedic trials and schedule your free demo today!
