
Clinical Trial Management System
Clinical Trial Management System consists of a number of modules, which can be used together, separately or with other modules on our platform. You may choose certain options now and increase your use of CTMS anytime in the future.


- TransparencyLearn more
Work done in one place
Measured, organized, reported - ComplianceLearn more
Inspection readiness and compliance
while easy to use - Modern business approachLearn more
Advanced technology
in a simple interface
All routine monitoring tasks covered in one application. Create Confirmation Letter, Follow-up Letter in one click with all related trackers added automatically. Site Visit Report create, review and approve workflow with electronic signatures is flexible and configurable to replicate your exact processes. Flexible smart trackers include action items, issues, deviations, etc. – there is no limit to what you can track and measure. All templates and documents are version controlled and automated. Poor internet connection at site? Use offline reporting capabilities of the system. Change of plans in the middle of the road? Implement changes and use new versions of templates and trackers. Hard to keep track of all visits? Use visits calendar and your tasks tab. Things are out of control? KPIs are tacked, alerts are set for you to never miss a bit of a quick running study.
Track what is going on at sites: enrollment, inclusion curve, in and out of time window visits, screen failures and so much more in one place. Widgets, reports and graphs, all exportable and at the your disposal. Site payments are set, measured, organized and tracked. Plan budgets for site payments, get automated information on visits and procedures completed, invoices are generated automatically – check, confirm, see the big picture or dive into details. Planned vs actual reports are everywhere on every data point you can think of.
Sites statuses, addresses, documents, contracts, qualification, vendors, submissions, site staff, timelines and so much more at hand. Keep all your Medical Institutions and Sites information in a clear organized manner, find all related information in few clicks. Manage submissions packages across countries, studies and sites in one! interface.
- CRA Activity Management
- Site visit planning and scheduling: Pre-Study, Site Initiation, Interim Monitoring, Monitoring Visits, Close-Out and any other type
- Centralized calendar and personalized calendars of planned visits
- Study role-based permissions
- Electronic signature
- Automated notifications and alerts based on various parameters
- Monitoring Visits reports, confirmation & follow-up letters generated automatically on customers templates
- Assessment metrics creation and CRA performance assessment
- All trackers are completely flexible and configurable – action items, issues, deviations, subjects enrollment and any other logs
- Business Intellig ence reporting – ANY report is possible
- Templates designer for all documents – full flexibility with confirmation letters, follow-up letters, site visits reports and questionnaires
- Customizable fields & trackers – all fields in monitoring section can be changed by user at no extra fee
- Site visits workflows are flexible and can be configured to reflect customer’s exact process
- Offline Site Visit Reports – you no longer depend on internet connection at sites
- API for integrations – full integration with TMF, EDC systems
- Ad-hoc reporting tool for cross-project and cross-module reporting – graphs, widgets, pies, grids – all exportable
- Sponsor step: enable optional sponsor step in the workflow to allow sponsor review and sign reports
- Subject Tracking & Invoicing
- Create study and multi-currency site budgets
- Invoice based on various triggers: visit, procedures, milestones, etc.
- Set up any payment rules with overhead percentage, cost and extra cost reductions
- Keep different site budget versions and invoice according to specific version
- Copy budget template to speed up trial set-up
- Export and report any data on invoicing into sites
- Track non-visit related activities (PTC management)
- Track unscheduled visits and procedures
- Manage open queries resolution
- Plan enrollment and compare with the real picture
- Plan and schedule patients visits
- Track all patient related data
- Import data from your EDC system or add subjects manually
- Get overall reports on ready to be invoiced, approved and paid activities
- Generate invoices & beneficiaries on configurable client-specific or ready- to-use templates
- Track invoices status
- Void or approve invoices online
- Investigators & Sites Management
- Feasibility process
- Site team assignment
- Site performance
- Capturing and tracking of all site communication
- Centralized IRB/LEC submissions and approval tracking
- Documents tracking (contracts, site regulatory documents, licenses and certificates)
- Investigators, sites, hospitals and out-patient clinics, vendor and regulatory authorities information
- Reports
- ImplementationWe can deliver a fully functional system in the timeframe from 3 to 10 (typically around 5) weeks, depending on the Clients involvement and the complexity of the Client’s requirements.
- PrivacyFlex Databases protects customers’ data, ensures following the security regulations, and mitigates all potential risks which are essential to building trust and delivering the high-level of service.
- SecurityFlex Databases takes a risk-based approach to security, and this page details the measures and technologies implemented to protect our customers.
- ComplianceFlex Databases System is compliant with all major international and local regulations such as: ICH GCP E6 R2, FDA 21 CFR Part 11, GDPR, etc.
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