CRMS - Clinical Research Management System

mdlogix’ CRMS is an enterprise-scale solution that helps manage the complexities of clinical research. From faster subject recruitment to more accurate billing, the CRMS is a powerful, user-friendly system that can result in dramatic savings in staff time and more efficient research.

The result of a collaborative development process in one of the world’s most demanding research environments, mdlogix’ CRMS is more than just a repository for data. It is a process management tool configured with the leading practices for the whole study team during all phases of research – from planning, through IRB submission, patient enrollment, data collection and analysis.

Crms Overview

CRMS Modules

Click on the modules below to learn what they can do for your research enterprise. Each module is rapidly deployable and designed to integrate with the others, forming a comprehensive CRMS. Modules can also be implemented separately or in any combination required to meet the needs of your organization.

Integration with Existing Institutional Systems

mdlogix’ CRMS is designed to facilitate data exchange with electronic medical records; laboratories; regulatory systems, finance/billing systems; authentication/user account management systems; and document libraries. This functionality eliminates the need to rekey data already stored in other systems.

Integration Services

The following integration services can be used to exchange data between your institution’s existing systems and mdlogix’ CRMS: SOAP, HTTPS, FTP, REST, LDAP, API, SQL and HL7, as well as many other application programming interfaces (API's). mdlogix staff will work with your organization’s IT department to ensure seamless integration between the CRMS and your systems.

User Communities and Security

CRMS users are granted secure, role-based access to only the data they require. Protocols, investigator brochures, CRF’s and clinical data are attributable, traceable and controlled. Users include investigators; research nurses; program managers; data managers; pharmacies; core labs; IRBs; executive/academic leadership; insurance departments; billing departments; and budget administrators. mdlogix’ CRMS is compliant with the FDA’s 21 CFR Part 11 regulation. We actively engage our clients in discussion of their institutions’ interpretation of HIPAA regulations, and ensure our system complies with their policies.

Informatics Standards

The informatics core of the CRMS comprises the CDISC (Clinical Data Interchange Standards Consortium), HL7 (Health Level 7) and caBIG (cancer Biomedical Informatics Grid) object models – the most important standards in the arena of human-subjects research.

mdlogix CRMS is Bronze Certified by the National Cancer Institute's Center for Biomedical Informatics and Informational Technology. The CRMS met the Cancer Biomedical Informatics Grid (caBIG™) Bronze level requirements in all four areas: interface integration, information models, data elements, and vocabularies/ontologies. mdlogix is working towards caBIG Silver level compliance.

Technologies Used

Common concerns about enterprise-strength software used in a distributed environment include performance, extensibility, security, scalability, reliability and serviceability. To address these issues, mdlogix’ CRMS is organized in the following layers: GUI, Business Process Layer, Data Access Layer, and Database. Through separation of layers, the system is more reliably constructed, operated, maintained and extended.

The main implementation tool for the CRMS is Ruby on Rails (RoR), a powerful web application development system. The mdlogix platform was created using RoR, and directly supports SQL Server, Firebird, Oracle, MySQL and other databases, as well as XML.

When developing in-house extensions for the CRMS, clients can use either Ruby or Java. Learn more about CRMS in a Java environment.