For medical device trial sponsors
Next-Generation Clinical Trial Software for Medical Device Studies
Our platform integrates AI-driven imaging analysis, real-time data validation, and unified EDC and PROMs management to enable medical device manufacturers to accelerate regulatory submissions by ensuring rigorous protocol adherence, data integrity, and comprehensive patient outcome tracking.
Fast-track your device approvals and cement your scientific legacy.
UNITY is a unified clinical trial platform that integrates ePRO, eCRF, and advanced imaging data to enforce protocol compliance and maximize data integrity. By reducing queries and operational costs, it accelerates regulatory approval timelines while generating robust, high-quality datasets that underpin your scientific legacy.
Our electronic data capture (EDC) system simplifies the collection of essential data for clinical trials, PMCF, and post-market surveillance.
- ePROs from diverse medical specialties
- Readily definable eCRFs and AE Forms
- Automated notes to patients and clinical sites
Our clinical trial management system (CTMS) automates workflows and error-prone tasks to maximize time and cost savings while mitigating risks to data integrity.
- Real-time status of data sets and study results
- Synched data between EDC and CTMS
- Drag-and-drop study designer
Imaging core lab services
We offer industry-leading imaging core lab services and are ready to support your trial end-to-end.
- Highly precise and accurate software- and AI-powered analysis of quantitative radiographic parameters
- Network of experienced radiologists for analysis of qualitative parameters
- Consultation for study design, endpoint selection, and data interpretation
Browser-based de-identification makes uploading images secure and straightforward.
- Integrated DICOM viewer
- Automatic image classification via AI-based algorithms
- Browser-based quality control
Looking to streamline your clinical trial?
Our platform for clinical trial management automates data capture and AI-supported analysis of medical data in one system.
Streamline your medical device trial management
Our integrated platform unifies EDC, PROMs, Image Management, and AI-driven Image Analysis to deliver comprehensive, high-fidelity datasets critical for medical device trials.
Our integrated EDC and PROMs software enables seamless collection and management of clinical data alongside patient-reported outcomes within a single, secure platform.
Automatically measures key radiographic metrics like Range of Motion, Implant Wear, and Device Migration—saving time and improving accuracy in your imaging assessments.
Gain 360-degree insights with regularly generated customizable reports highlight data status, enrollment and retention figures, and adverse events.
Collect real-world-data directly from patients and physicians. Continuously demonstrate the safety and efficacy of your device, inform treatment plans, and expand your commitment to evidence-based medicine.
Ensure protocol compliance and data integrity in medical device studies
UNITY ensures strict protocol compliance and maintains data integrity throughout medical device studies by automating quality checks and standardizing data workflows.
Browser-based image data transfer, including GDPR-compliant, automated anonymization before transmission and storage
Interface between your system landscape (HIS, LIS, RIS, PACS) and UNITY software based on HL7 v2, HL7 v3, CDA and FHIR.
FDA CFR Part 11, GCP, Management system certified according to ISO 27001 and 13485
Ready to see how it works?
Discover how our partners are already using UNITY to conduct IDE studies, obtain market approval, and set up multicenter medical registries.
Simplify your clinical trial management with our UNITY platform
For medical device manufacturers, valid results from clinical trials are essential for market approval. But these are often lengthy and very cost-intensive. UNITY offers numerous advantages that simplify clinical trial management and save resources.
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At RAYLYTIC we know that medical device manufacturers face a unique challenge: the long-term, efficient, and compliant collection of diverse data that demonstrate the objective safety and efficacy of their products.
This is why we developed UNITY – a scalable, modular platform for clinical trial management that automates the collection and analysis of ePROs, eCRFs, and medical imaging data. Together with our extensive repertoire of imaging core lab services, UNITY ensures not only that your study runs smoothly – saving your trial up to six-figure amounts – but also generates the highest quality, scientific results for regulatory filings, post-market research, publications, and the evidence-based treatment of patients.
How RAYLYTIC customers profit from our solutions:
As we bring forward more accurate tools for implant placement, we are in need of better methods to assess postoperative alignment and accuracy to planned placement. It seems you have not only filled that need, but also automated the process of acquiring accurate information.
RUSSELL SCHENCK
Director Clinical Strategy at Zimmer Biomet
The UNITY platform is easy to use and the collection of PROMs/CRFs is robust in daily use. The automatic anonymization of the uploaded image data and their statistical analysis are also extremely helpful.
PROF. MICHAEL PUTZIER
Chief Senior Physician at the Center for Musculoskeletal Surgery/Charité Berlin
UNITY facilitates getting patient data and outcome measurements to a higher level. The system is easy to use, the image upload is smooth and complete data analysis is provided quickly and thoroughly, including discussions and advice for improvement.
DR. NANCY LAMERIGTS
Former VP of Research and Marketing at Emerging Implant Technologies
The RAYLYTIC team is extremely competent, diligent and fun to work with. They solve problems and offer support wherever it is needed to get a project up and running. We have already set up multiple studies with RAYLYTIC and are also cooperating on several other projects.
DR. ANDREA WEILER
Director Medical Scientific Affairs at Aesculap/B. Braun
We have built databases for two retrospective studies including image analyses with RAYLYTIC. They helped with designing the eCRF, implemented and trained us on how to navigate the database, provided necessary documents and went above and beyond to help us achieve our goals. Working with RAYLYTIC is fantastic. The team is highly professional and extremely knowledgeable on how to run clinical retrospective studies.
DR. LAMIA BOSLI
Manager Clinical Data Management at RQMIS
RAYLYTIC has created a product that includes all the elements I need for my research, with the highest quality and integrity. In addition, the best part of this product is actually the customer service. I cannot stress enough how impeccable the entire team at RAYLYTIC is, which ultimately makes this product even better.
LINDSAY OROSZ
Senior Manager Clinical Studies at Virginia Spine Institute
The sites and CROs involved in the trials are so relieved to finally have a platform that automates redundant tasks and ensures highest quality data with little extra effort. Our CROs and principal investigators have been extremely impressed with the quality of data coming out of sites and their interactions with RAYLYTIC.
ANDY MURILLO
Spinal Stabilization Technologies
With the use of UNITY, the basis was laid for not having to maintain or introduce an unlimited number of individual solutions for the processing of PROMs and PREMs. This relieves IT managers in the long term.
DANIEL WUNDERLI
ICT-Project Manager at KSW
With UNITY, we are offering surgeons an intuitive way to generate and access meaningful registry data.
DAVID OKA
VP Business Development and Compliance at Innovasis