Comprehensive Clinical Trial Management
This highly-regarded Clinical Research Information System has been selected by 20 of the top 25 rated US medical institutions, according to the U.S. News and World Report.
This web based software supports patient recruitment, patient scheduling, IRB and study monitoring, project planning, study design, protocol compliance, budget, invoicing, and milestone management; data safety monitoring, adverse event reporting, system integration, and study execution.
For investigators, opportunities abound for better use of information systems and clinical databases in medical research. This sounds obvious but such systems are not generally in production today. At least 95% of study administration is done on paper, in spreadsheets, and on various, sundry databases. Utilizing a structured approach, this integrated system provides investigators, study coordinators, and central managers at research centers with unprecedented research information capabilities.
For sponsors, this Research Application solves “the last mile” problem. It provides end-to-end electronic clinical trial data collection, where study data comes directly from source systems (e.g. labs, adverse events and medical records) at the sites, to the lead investigator and monitors, and on to the CRO and/or sponsor. Such a system infrastructure is a major leap forward in clinical trial automation for both sponsors and investigators. It enables “Direct Data Capture” as compared to “Electronic Data Capture”.
Study Administration
- Protocol management
- Patient scheduling
- Regulatory reporting
- Adverse event management and reporting
- Budgeting, milestones, invoice, and payment/receipts processing
- Management of research organizations, personnel, and collaborators
Clinical Data Management
- Patient profiling
- Longitudinal, patient-level information collection and analysis
- Study-specific data collection and analysis
- Workflow configuration
- Integration with internal and third party information systems
Advantages
- Access to what some believe is the most advanced, carefully considered clinical research information system that is commercially available
- HL7 compliance. Dozens of working lab, medical record, and device interfaces are already in production
- The software was designed from the ground up to provide off-the-shelf support for all of study administration, clinical data management, adverse event reporting, and integration with internal and third party cancer center systems through one integrally-designed system
- The ability to add, modify and apply study and customer specific data dictionaries with minimal technical involvement
- Compliance with industry standards (such as 21 CFR Part 11) and a commitment to supporting standards that foster higher collaboration
- Patient-level and study-level system architecture. Most research systems were primarily designed for research sponsors and focus on the needs of single studies. The system architecture is unique and considers both patient- and study-level views — and also integrates the two.
- Advanced technology and security features to support multi-institutional, cooperative trials, community-based research and patient self-reporting in a single and federated database environment
- Through all these capabilities, the application is helping to transform the information model in clinical research from its current, largely disintegrated state to one where investigators and sponsors can work hand in glove. In doing so, we believe that this Clinical Research Information System can help its customers and the research community in general, unleash tremendous improvements in research productivity, collaboration and, ultimately, patient care.
