Technology solutions that provide efficiency to clinical trial management
Rho utilizes a combination of proprietary applications and partnerships with third-party providers to offer our clients clinical trial technology solutions that meet our high standards of quality. Our integrated technology solutions increase our flexibility and maximize efficiency for your clinical trial project or program.
Proprietary technology solutions built on years of clinical research experience
The success of our proprietary technology solutions is a result of our industry-defining work in statistics, clinical data management, and project management in more than 30 years of support of clinical research. Our clinical trial technology solutions were built from an early and consistent commitment to apply our knowledge and experience to tools that improve the way we deliver services. Our proprietary solutions comply with applicable regulations and industry standards, including 21 CFR Part 11.
Clinical trial technology solutions that make the most sense for our clients
When working with our clients to choose or recommend a tool, our first responsibility is to provide our clients with the right solution, regardless of brand. Whether it’s one of ours or a third-party tool, we consider speed, flexibility, pricing, and ability to integrate with existing tools.
Below are some of the most popular technology solutions Rho offers:
A robust EDC/CDM solution to manage your clinical trial data
Medidata Rave® is an advanced and robust system for capturing, managing and reporting clinical research data, designed to help life science companies optimize their research investments by efficiently streamlining the clinical trial process. Rave’s single EDC/CDM platform, coupled with high scalability and software-as-a-service (SaaS) architecture, provides a cost-effective approach to quickly implement a single clinical trial or support an enterprise-wide deployment for multiple therapeutic areas, phases and studies. The wide-support of industry standards and a rich set of on-demand data extraction and reporting tools provide a robust platform to manage site-, patient- and lab reported data and rapidly make it available for analysis and submission.
Oracle® Siebel Clinical Trial Management System (CTMS)
Effective and efficient clinical trial management
The Oracle Siebel Clinical Trial Management System (CTMS) is a centralized, standardized tool for collecting, managing, and reporting key study metadata, including information about:
- Study trip report development and tracking
- Clinical site information
- Clinical site staff information
- Sponsor/CRO staff information
- Vendor information
The system draws on multiple data sources to facilitate tracking, documentation, and communication tasks essential for effective trial management.
Deploy a more powerful, accessible, and reliable randomization system
Our web and voice randomization, patient diary, supply chain management, and notification system uses state-of-the-art technology to develop tailored solutions for managing clinical trials. RhoRAND™ is customized by experienced Application Configuration Specialists to meet the specific needs of any trial. It provides simple data collection for subject enrollment and randomization using a touch-tone phone or web browser as well as modules to handle resupply requests and receipt of investigational product shipments, emergency unmasking, cohort management, and real-time summary report generation. RhoRAND™ ensures protection of vital study data with user authentication protocols, dedicated servers, and remote network backup. 24/7, multilingual support is available.
Market Leading eTMF Technology
Phlexglobal offers PhlexEview, a purpose-built eTMF solution that delivers sophisticated, intelligent, real-time, active TMF management to increase Inspection Readiness, visibility, and control of essential clinical trial documentation.
PhlexEview is far more than a document repository, providing robust quality and processing workflows, and the ability to perform metadata analysis across trials and compounds in order to aggregate data, identify trends, and manage compliance across the lifecycle of a development program.
PhlexEview offers a single source of truth for TMF Completeness, Quality and Timeliness, and enhanced visibility to oversee trials more effectively. As The TMF experts©, Phlexglobal is uniquely able to offer a scalable, configurable, personalize-able, user friendly, and high performance/high availability system that offers secure, remote, role-based access to sponsors, sites and Regulatory Inspectors.
A comprehensive solution for pharmacovigilance
Oracle® Argus Safety is an advanced and comprehensive pharmacovigilance software system. An off-the-shelf, web-based software package, Argus provides the collection, tracking, reporting, and analyzing of adverse events and serious adverse events for drugs, biologics/vaccines, and devices in accordance with global regulatory requirements. It ensures the integrity and confidentiality of safety data used in support of regulatory submissions.
Argus provides a robust library of reports and the flexibility to create ad-hoc reports to meet sponsor and project needs for safety data analysis. The ease of database configuration allows for quick start-up and ongoing addition of studies, products, and sites. Argus Safety and Rho Product Safety provide a centralized, global safety solution for the life cycle of a product from early clinical development through post marketing.
Cost effective EDC solutions
Medrio offers an integrated eClinical software platform with a fully hosted Electronic Data Capture (EDC) system. Their revolutionary CloudEDC™ technology features an easy to use drag-and-drop interface, allowing study managers to build their studies in days instead of months without any programming required. Medrio's new mobile suite, mSource, supports both event-based and subject-based workflows, offline data entry, and PRO. Although Medrio has vast experience in all study phases, with over 500 Phase I trials to date, its m1 application leads the way in Phase I trials. Plus, Medrio costs up to 75% less than traditional EDC solutions!
Ensure quality at every step of the clinical data management process
Rho's clinical data management system provides flexibility by being customizable to meet the exact needs of each client’s project. The software enables true double-data entry and independent review of the referee decisions log and can automate query generation from team-specified validation rules. Because RhoDMS is dictionary driven, it enables Rho’s Data Management experts to set up and start trials with extraordinary speed. RhoDMS consistently excels in sponsor and internal audits and complies with FDA standards and guidance documents.
Generate data displays quickly, accurately, and conveniently
For the rapid generation of statistical tables and listings, we use a proprietary suite of applications featuring RhoTABLES. Fully validated and SAS®-based, RhoTABLES lets our Statistical Programmers generate data displays quickly, efficiently, and accurately so they can concentrate on the core of your study—the data.
The portal that provides online documentation collaboration
RhoPORTAL serves as a collaboration platform for both single-study and multi-study clinical-trial projects. As a clinical research information delivery system and collaboration portal, it provides a secure, access-controlled, web-based interface to clinical study materials for Rho clients. Using modular components, RhoPORTAL serves customized content to each team tailored for their particular needs, such as individual study sub-sites, private DSMB areas, or specialized committee pages. RhoPORTAL components include custom announcements, study document and report repositories, document and manuscript development support, dashboard displays, interactive graphic reports, and video player support.
Applied Data Visualization
To provide more intuitive access to your clinical data, better tools to understand and analyze data, and cutting edge methods for reporting trial results, we’ve created user-friendly graphics using the latest analytical techniques and data visualization tools. Rho’s interactive graphics are designed to allow users to explore their data from a standard web browser, without the need to purchase or install specialized software. A toolbox of standard interactive graphics for common study metrics is available. These tools are flexible and can be adapted to meet the needs of a given study. Custom data visualizations and data explorers can be tailored to the needs of each individual study or program. Live examples, source code and documentation can be found at http://graphics.rhoworld.com.