ClinPlus offers a web-based Clinical Trial Management System for Sponsors and CROs that is flexible and scalable. It will empower your organization to manage and collaborate on clinical trial operations while the intuitive, straightforward design allows rapid deployment and training with a very high level of user acceptance and satisfaction.
ClinPlus CTMS is available as a hosted solution or may be installed at your organization. When using the software, you will dramatically reduce your trial administration costs while remaining 21 CFR Part 11 compliant.
ClinPlus CTMS provides flexible tools to easily configure the system to meet unique requirements of each client and each study to provide on-the-fly visibility to critical trial data and operations milestones, and satisfactorily meet the changing trial demands of Sponsors and CROs.
ClinPlus CTMS will integrate with virtually all EDC, IVRS systems and Microsoft SharePoint. It offers intelligent tools for importing and exporting global and project specific data.
ClinPlus CTMS is a comprehensive system with with only some of the highlights listed below:
- SQL Server database provides secure, stable and centralized access to all data
- Compatible with virtually all modern browsers
- Full role-based security configurable down to the study level
- 21 CFR Part 11 compliant (electonic signatures, security and audit trails)
- Manages your global contacts and global institutions databases
- Tracks enrollment numbers and rates for each site and graphically presents enrollment metrics and projections
- Collects, stores and manages regulatory and other documents
- Stores documents directly in ClinPlus CTMS or link to your SharePoint site or file directories
- Provides alerts for expiring or missing documents and other events
- Many system configurations may be overridden at the study level
- Add custom fields to many system tables
- Add custom tables
- Robust integration capabilities, including direct integration with Medidata Rave and all other EDC and IVRS systems
- Schedules and tracks study events and milestones
- Tracks deviations, issues and SAEs
- Fully integrated Site Visit Report tools eliminates redundant entry of data
- Site Visit Report workflow tools support drafting, reviewing, approving and electronic signatures. A complete history of each report is maintained
- Schedules and manages site visits through the calendar features
- Provides comprehensive high level and detailed financial information
- Manages finances and payments to sites and vendors
- Manages flexible site budget templates, payment triggers, holdback amounts, pass-through costs, etc.
- Automated and manual site/vendor payment approval process with detailed invoice generation
- Study supply inventory management
- Access standard report templates, or create custom reports. Includes automated scheduling and delivery of reports
- All reports are provided in either PDF or Excel spreadsheet formats, maximizing access to all system data
- Maintains searchable communication logs