Clinical trial management

For medical technology and pharmaceutical companies

Simplify your clinical study management

UNITY Research

UNITY Research is a clinical trial management system that optimizes and automates the work processes involved in collecting and analyzing data. The cloud-based software provides medical technology and pharmaceutical companies with legally compliant and interoperable data access without the need for additional IT resources.

With UNITY Research, clinical and postmarket (PMS/PMCF) studies can be implemented, managed efficiently and evaluated using high-performance analysis and control tools.

The generated clinical data is high-quality and accelerates the introduction of products to the market.

UNITY Research optimizes your study management:

Easy to use

Drag and drop study configuration, responsive layout, multilingual interface

Intuitive operation

Standardized statistics, predefined reports and a filter function for an overview of existing and missing data

Significant time saving

Interfaces for automated data acquisition and access to your data, at any time and from anywhere

Efficient study management

Real-time reports, automated notifications, risk-based monitoring and numerous dashboards and overviews

Automated
processes

Centralized data handling and automation of error-prone routine tasks optimize the management of approval and postmarket (PMCF) studies

Fulfilment of regulatory
requirements

UNITY Research is legally compliant with MDR, GDPR, ISO 13485, HIPAA, 21 CFR Part 11, 21 CFR Part 820, IEC 62304, BDSG and GCP

Effective management of approval and
post-market (PMS / PMCF) studies

UNITY Research including RayView

AI-supported image data analysis for clinical studies in orthopedics

Based on experience from more than 100 studies (postmarket surveillance, IDE, registers and research) managed in Europe and the U.S., RAYLYTIC has expanded digital study management for medical technology and pharmaceutical companies to include automated, AI-supported image data analysis (CT, MRI, X-ray) in the fields of hip/knee replacement and spinal surgery.

The combination of UNITY Research and AI-supported image data analysis with RayView (approved as Class 1m medical product) has been specifically developed with a view to the special features and specific requirements of clinical studies in orthopedics.

UNITY Research including RayView

AI-supported image data analysis for clinical studies in orthopedics

Based on experience from more than 100 studies (postmarket surveillance, IDE, registers and research) managed in Europe and the U.S., RAYLYTIC has expanded digital study management for medical technology and pharmaceutical companies to include automated, AI-supported image data analysis (CT, MRI, X-ray) in the fields of hip/knee replacement and spinal surgery.

The combination of UNITY Research and AI-supported image data analysis with RayView (approved as Class 1m medical product) has been specifically developed with a view to the special features and specific requirements of clinical studies in orthopedics.

AI-supported analysis of medical image data

AI-supported image data algorithms for the objective, reliable and highly precise analysis of radiographic parameters for the quantitative and qualitative evaluation of implant performance.

More than 100 different radiographic parameters can be measured fully or partially automatically. By means of the precise analysis, meaningful conclusions can be drawn even from smaller patient cohorts.

This makes it easy to evaluate and document image data relevant to trials.

Individual data management system

For the evaluation of clinical trials in the fields of hip/knee replacement and spinal surgery, multiple indices and adjacent segments often need to be considered. This creates significant requirements for data capture and image data analysis.

It is just for this purpose that RAYLYTIC has developed the ideal platform for effective study management with AI-supported image data analysis that meets not only all regulatory requirements but also the highest scientific demands.

UNITY Research can be adapted quickly and easily to your requirements within the scope of our onboarding services.

Process optimization by UNITY Research using RayView

Efficient capture and AI-supported analysis of medical data in one system
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High-precision image analysis

Reliable analysis of more than 100 radiographic parameters: sagittal balance, loss of correction, disc height, segmental instability and prosthetic wear

High-performance data analysis

Comprehensive data analysis and data export functions with reporting for a quick, complete overview

Easy data integration

Interface between your system landscape (HIS, LIS, RIS, PACS) and UNITY Research software based on HL7 v2, HL7 v3, CDA and FHIR

GDPR-compliant data transfer

Browser-based image data transfer, including GDPR-compliant, automated anonymization before transmission and storage

Range of Motion (RoM)

Measurements such as range of motion are possible with a 15-fold higher precision compared with experienced radiologists and surgeons for clinical studies

Quality control and assurance

Validation and edit checks in real time Midstudy changes for protocol adjustments in an ongoing study

How RAYLYTIC customers profit from our solutions:

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

Our focus: The success of your clinical studies and trials