Risk-Based Quality Management
At Rho, our clinical data management team plays an active role in our Risk-Based Quality Management (RBQM) process, which involves clinical data and operational quality risk assessment, planning, and management through a study’s life cycle. Our sophisticated methods and tools for data review scale to trials of all sizes and support risk-based monitoring, central monitoring, off-site monitoring, and targeted site data verification (tSDV).
EDC, ePRO/eCOA, and Database Build
We are experienced with a variety of commercially-available electronic data capture (EDC) systems and other remote data capture solutions including a variety of electronic Patient Reported Outcomes and electronic Clinical Outcome Assessments (ePRO/eCOA) platforms. All of our Data Managers are certified Medidata Rave™ study builders, which ensures in-house database build activities and allows for active control of our study timelines. Additionally, we maintain in-house involvement in the development of various EDC add-ons and modules to both control timelines and leverage our 35+ years of data management and systems expertise to construct effective and efficient data system integrations.
Decreasing Time to SDTM
In keeping the downstream users of the clinical data in mind, Rho Data Management maintains a standard library of CDASH-compliant case report forms to both shorten EDC build times and expedite the transformation of EDC data into submission-ready SDTM.
Holistic Data Strategy
Data diversity and number of available data capture systems is increasing, and we can help sponsors develop a cohesive data strategy when it comes to data collection and integration. While the task of creating a systems-based strategy seems daunting given the number of vendors, systems, and combinations of data capture solutions, Rho works with clients to develop a holistic, risk-based approach to building and linking a variety of data systems.
Clinical Data Consulting, Evaluation, and Rescue
Our Data Management team can also provide clinical study rescue, and clinical data management project consulting services. Using our custom anomaly detection and review tools, we are able to conduct clinical database health checks without the addition of potentially hundreds of hours of custom programming to a study’s budget.
Our Clinical Data Management Services include:
- Data Management Plan and strategy development
- eCRF & database development
- Data validation plan development
- User Acceptance Testing (UAT)
- Vendor management and integration
- System query management
- EDC user management
- Manual data review
- External data reconciliation
- SAE reconciliation
- Rolling data freezes/lock
- Anomaly detection and tread identification
- Database finalization and lock