Clinical data management made simple.
Clinical trial management system (CTMS)
Clinical trial teams face enough pressure as it is. That’s why we made a cloud-based clinical trial management system (CTMS) that takes care of the details.
Better data quality, streamlined communication with sites, reliable study planning and monitoring: The CTMS in our UNITY platform automates routine tasks to maximize the efficiency of your study.
Explore below how over 200 studies have used our UNITY platform to achieve success while saving precious resources.
Automate time-consuming and error-prone tasks to save yourself stress, time, and unnecessary queries.
Perform automated data quality checks and notify sites of upcoming deadlines to reduce delays.
Centralized study management
Keep all your CTAs, CRAs, and PIs on the same page throughout the entire study lifecycle.
Centrally organize and manage EDC data, documents, and permissions in our “single source of truth” CTMS.
Gain a complete overview of data, queries, and study progress.
Monitor the progress of your study including completeness and fulfillment of critical milestones.
Keep your study on track with a flexible clinical trial management system.
Accounting for all the unexpected challenges of a clinical trial is impossible, but automation can minimize potential risks and delays.
Set up and deploy complex study designs within weeks, not months
Purpose built by clinical trial managers for the clinical affairs specialists of today.
With the integrated CTMS in our UNITY platform, constructing complex databases takes as little as an afternoon, and data collection can be underway within 2 weeks or less. Define study endpoints, set examination periods, and add new sites, patients, and roles with just a few clicks.
Intuitive database design via drag and drop
Easily definable study endpoints, including imaging endpoints
Mid-study changes with no downtime
Automated notifications of sponsor / site users in case of protocol deviation
Real-time validation and edit checks
Automated notification of sites of upcoming and overdue data
Automated update of data status
Automated data transfer to third party registries
Adaptable user interface for all stakeholders
Data entry via tablet, mobile phone, upload of source and archival documents
Conduct hassle-free multicenter trials
Decentralized doesn’t have to mean disorganized.
Automate error-prone processes, data collection from patients, and communication between stakeholders to effortlessly manage multicenter trials while minimizing risk and winning back time for your clinical trial managers and research associates.
Integratable with EHR systems, scheduling software, registries, PACS, ERPs, labs, archives via HL7 v2, HL7 v3, CDA and FHIR
Two-way interface with other CTMS or company-specific data collection platforms
White labeling
Dictionaries such as MedDRA, RadLex, and others upon request
Medical codes assignable to verbatim items on existing data
Synonym lists
Conflict and synonym detection
Auto-encoder for related medications and AEs
Source data verification with variable granularity (e.g., field, page, form, patient level)
Electronic investigator and patient signatures in compliance with 21 CFR Part 11
Display of all open and resolved queries
Simple query communication and resolution process
Site-specific alerts for upcoming and completed ePROs, eCRFs
Alerts in case of adverse events
Push notifications to study managers when patients are added or removed from study
Rest assured that data are complete, safe, and compliant
At RAYLYTIC, we know that decentralized, multicenter studies harbor more challenges than conventional clinical studies.
That’s why we built the CTMS in our UNITY platform on a best-in-class SaaS architecture that mitigates compliance risks and affords you maximum transparency into the planning, tracking, and reporting of study data and documents for your approval, IDE, or post-market study (PMCF).
Customizable reporting functionalities, including:
Data quality (completeness, timeliness)
Recruitment numbers
Oustanding queries by document type
Adverse events and complications
Exports in Excel, HTML, CSV, PDF formats
Role-specific access and logging of all system activity in FDA 21 CFR Part 11-compliant audit trail
Compliant with GDPR, GCP, and HIPAA
ISO 27001 and ISO 13485 certified
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