UNITY
While many clinical studies have basic similarities, others are extremely specific with highly individual requirements. Clinical studies in orthopedics, e.g., spine trials, are particularly demanding with regard to data collection and analysis as they often include the assessment of several indexes and adjacent spine levels.
Our highly flexible database design and electronic data management system can be adapted precisely to your requirements and we offer a full-service package to guarantee the success of your multi-center clinical trials and research studies.
- easy study definition via drag & drop – no training required:
- examination periods and tolerances
- modalities (CT, MRI, X-ray)
- endpoint selection: over 150 predefined radiographic parameters currently available, with possibility of integrating customer-specific parameters
- consideration of distinctive spinal features: several index segments, adjacent segments, lumbarization and sacralization
- trial-specific creation of radiography protocols, recording instructions and data exchange protocols
- examination periods and tolerances
- modalities (CT, MRI, X-ray)
- endpoint selection: over 150 predefined radiographic parameters currently available, with possibility of integrating customer-specific parameters
- consideration of distinctive spinal features: several index segments, adjacent segments, lumbarization and sacralization
- browser-based, robust transmission of image data, incl. GDPR-compliant automatic anonymization prior to transfer and storage
- integrated quality assurance for assessment and documentation of image quality
- network of experienced radiologists and orthopedic surgeons for objective analysis of qualitative endpoints, e.g., of adverse events or side effects
- real-time validation and edit checks
- mid-study changes to accommodate protocol amendments
- intuitive dashboards with overview of existing and missing data (sort and filter functions) for study management, hospital staff, monitors, sponsors
- configurable, automated email notifications and status reports to clinics, sponsors, monitors and CROs
- sort and filter functions for ad hoc data queries
- extensive data analysis and data export functions
- remote-monitoring and granular user access rights
- audit log with fully traceable change history according to GxP
- assistance in less than 30 minutes during business hours
- ongoing support to the central study and data entry teams
Plan, monitor and analyze clinical trials or postmarket monitoring studies with UNITY and involve all stakeholders via the same platform.