Clinical Data Management

Our clinical data management experts provide unrivaled speed, flexibility, and quality

Clinical Data Management has been a cornerstone of our clinical research services for more than 25 years. We have spent the last 2 decades sharpening our skills and processes to consistently deliver databases of the highest quality with unmatched speed and flexibility. The Rho clinical data management staff is well versed in good clinical data management practices (GCDMP) and has strong technical, programming, and communication skills. Whether your clinical trial is a multi-site post-marketing study with thousands of subjects or a one-center Phase I study with fewer than 50 subjects, Rho's clinical data management team will provide a customized, cost-effective, and flexible approach to meet all of your data needs.

Clinical data management depth demonstrated each day

Rho's clinical data management team consists of highly skilled staff; many of which have health care–related backgrounds. Rho clinical data management staff members have served as architects and implementers of clinical trial information management systems in pharmaceutical companies and National Institutes of Health–sponsored studies. In addition, Rho's clinical data management staff is actively involved in activities of the Drug Information Association (DIA), Society for Clinical Data Management (SCDM), and the Clinical Data Interchange Standards Consortium (CDISC).

Data collection that meets our clients' needs

Paper or electronic data capture (EDC)? Clinical data acquisition standards harmonization (CDASH), Study Data Tabulation Model (SDTM), or your own standard? Rho understands that navigating today's data collection and submission landscape can be complicated. Well-informed decisions about your study's data can save time and money later in your program. Rho's clinical data management experts can advise you on the best path for your study and can implement data collection and formatting strategies to maximize your investment.

Electronic data capture: Rho can recommend an EDC strategy that's right for your program. Our staff has extensive experience providing clinical data management services using EDC and can collaborate with you to choose the option that best meets your program's needs. Whatever the technology, Rho staff will ensure the database and validation checks are deployed quickly, that sites and users are trained on the system, and that results are available in a clean database, which is locked on time.

Paper-based data capture: If paper is the best choice for your program, Rho offers robust data collection using paper case report forms (CRFs). Rho's proprietary clinical data management system, RhoDMS™, ensures fast and flexible setup and consistently clean data. 21 CFR Part 11 compliant, our clinical data management system provides for CRF inventory and tracking at the page level, true independent double data entry with a third-party referee, and strong custom reporting. Queries are generated at the variable level to ensure pinpoint accuracy, and our databases consistently have less than 1 error in 10,000 analyzable fields.

Data formats and FDA submissions: Need advice on the best format for your data? Our Data Managers are experts in data standards. We can evaluate your entire program to help you determine the best format for your project's data and expedite the eventual creation and approval of your submission package. We can also convert legacy data to the most current standards.

Specialized expertise in medical coding and clinical data management programming

At Rho, medical coding is performed by a team of physicians and registered nurses. Specific coding rules can be applied at the sponsor, project, or individual event level to ensure consistency and accuracy across your entire program. In addition, our medical coders are expert clinical resources for our clinical data management staff. Our clinical data management programmers have years of experience with SAS® programming, program validation checks, data listings, patient profiles, and much more.

Our comprehensive clinical data management services include:

• Clinical clinical data management consulting
• CRF/eCRF design
• Database development & deployment
• Data entry and tracking
• Customized clinical data management programming
• Third-party data integration
• Knowledge and use of current data standards (SDTM, CDASH, and CDISC)
• Data conversion to any sponsor's data specifications
• Interim analysis readiness
• Medical coding and serious adverse event (SAE) reconciliation
• Customized status reporting and data listings
• Database closeout and delivery
• Clinical trial rescue services
• Government/Non-governmental organization (NGO) projects

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