Unified Cloud based solution to meet Pharma and CRO core business needs, eliminating the burden of a typical Clinical Trial department which is struggling with poorly integrated workflows and resources, outdated procedures and multiple manual tasks.
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Electronic Data Capture (EDC)
- Configurable data collection forms
- Configurable data collection schedule
- Collection of data from disparate locations (web-based data input)
- Integrity / logic checks on data (Conditional Actions)
- Query system to work through data issues in conjunction with Conditional Actions
- Structured and real-time extraction of data
- Role-based security to define access
- Case Report Form (CRF) and Informed Consent Form (ICF) Tracking
- Rule-Based Edit Check Engine
- Medical Coding (MedDRA and WHODrug coding)
- Data exports to SAS, ODM, CDISC, XML and Excel formats
- Capture Medical History
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Clinical Trial Management System (CTMS)
- Dashboards & Reporting
- Advanced Study Planner
- Study Set-Up Templates & Study Creation Wizard
- Investigator Database
- Recruitment Planning & Tracking
- Extensive Document Management
- Communications Management
- Query Management
- Ticketing system (Issue Management)
- Site Management
- Robust Monitoring
- Complete Task Management
- Country Set-Up
- Subject Management
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Safety Database
- Protocol management
- Configurable case workflow management
- Case management
- Roles based user permission
- Roles based access
- Document Management System
- Integration with MedDRA
- Integration with WHODD
- Case output in FDA 3500A and CIOMS
- Query Management
- Graphical and Tabular line listing and other reports
- Multilingual (English and Chinese)