Rho is recognized for consistently producing clinical trial databases to the highest standards. Our reputation for speed and high quality work is based upon the following:

• Designing, implementing, and validating a custom database for a new study, typically in less than two weeks;
• Performing all database closure activities, including comprehensive, independent QA, within two weeks of receiving the final resolved query;
• Delivering the final databases with no more than 1 error per 10,000 analyzable fields.

Rho's clinical trial information system has passed comprehensive audits and meets or exceeds all FDA standards and guidances. We rapidly design and implement customized, fully validated databases for studies of all sizes and have managed data from studies conducted in each hemisphere of the globe.

Our experts have served on FDA and pharmaceutical advisory committees and review boards, as consultants to the FDA on clinical trial information management and clinical data management practices (GCDMP), and as architects and implementers of clinical trial information management systems in pharmaceutical companies and National Institute of Health-sponsored studies.

Rho's clinical trial information management services include:

Clinical Data Management Consulting Study Start-up Activities Protocol Review for data management issues Data Management Plan to meet demands of the Sponsor CRF design/consultation, production, and distribution Total shipment tracking or Just-in-TimeTM form distribution Paper CRFs, Web-print CRFs, EDC Data Processing Data inventory and tracking-real time status of every CRF page or data record Comprehensive pre-entry review of study data, including cross-reference within study subject In-house second clinical review True independent double data entry with third party referee Systematic quality control procedures assuring complete data cleaning Smooth integration of third party data (e.g., lab, ECG data) Expert computer-assisted medical coding using industry-standard dictionary as specified or provided by Sponsor

Query Management Thorough computerized error detection-univariate and multivariate edit checks Exclusive Rho StatusSymbol ™ status flags for every data value Consistent and clear Data Clarification Requests (DCRs) using template for issue/resolution-sites process our queries quickly and easily Comprehensive, real-time DCR tracking and status Database Closeout Activities and Lock Online data tracking and reporting Independent, comprehensive QA audit of locked databases Seamless electronic data transfers to a wide variety of sponsor database systems HL7, CDISC cooperative State-of-the-art data warehousing Electronic data submissions to FDA, compliant with all regulations and guidances

With over 20 years of experience providing clinical data management services to the pharmaceutical and biotechnology industries, as well as to NIH-sponsored research, Rho has a clear picture of what our customers want, the way clinical trials work, and the best way to conduct efficient, effective data management. When you need a fast, accurate database, Rho produces results right and on time.