In clinical trials, any mistake can cost you a whole study. That’s why one of the essential things in the studies is processes and procedures. But what’s the first emotion you get about these words? Let me guess: disappointment, fear, irritation?
CTMS (Clinical Trial Management System)
CRA Activities Monitoring. Subject Tracking & Invoicing. Investigators & Sites Management.
Automate your routine CRA tasks with CRA Activity Management
- Create confirmation and follow-up letters in one click with all flexible smart trackers added automatically.
- Configure Site Visit Report workflow with electronic signatures to replicate your exact processes.
- Poor internet connection at site? Use offline reporting capabilities of the system.
Track what is going on at sites with Subject Tracking & Invoicing
- Have all the information you need in one place: enrollment, inclusion curve, in and out of time window visits, screen failures and so much more.
- Use flexible and exportable widgets, reports, and graphs.
- Set, measure, organize, and track site payments.
Organize all information on investigators and sites with Investigators & Sites Management
- Have sites statuses, documents, contracts, qualification, vendors, timelines and so much more at hand.
- Keep all your Medical Institutions and Sites information in a clear organized manner with just a few clicks.
- Manage submission packages across countries, studies, and sites in a unified interface.
CRA Activity Management
- Site visit planning and scheduling: Pre-Study, Site Initiation, Interim Monitoring, Monitoring Visits, Close-Out, and any other type
- Study role-based permissions
- Automated notifications and alerts based on various parameters
- Assessment metrics creation and CRA performance assessment
- Business Intelligence reporting – ANY report is possible
- Customizable fields & trackers – all fields in monitoring section can be changed by user at no extra fee
- Offline Site Visit Reports – you no longer depend on internet connection at sites
- API for integrations – full integration with TMF, EDC systems
- Sponsor step: enable optional sponsor step in the workflow to allow sponsor review and sign reports
- Centralized calendar and personalized calendars of planned visits
- Electronic signature
- Monitoring Visits reports, confirmation & follow-up letters generated automatically on customers templates
- All trackers are completely flexible and configurable – action items, issues, deviations, subjects enrollment and any other logs
- Template designer for all documents – full flexibility with confirmation letters, follow-up letters, site visits reports and questionnaires
- Site visits workflows are flexible and can be configured to reflect customer’s exact process
- Ad-hoc reporting tool for cross-project and cross-module reporting – graphs, widgets, pies, grids – all exportable
Subject Tracking & Invoicing
- Create study and multi-currency site budgets
- Set up any payment rules with overhead percentage, cost and extra cost reductions
- Copy budget template to speed up trial set-up
- Track non-visit related activities (PTC management)
- Manage open queries resolution
- Plan and schedule patients visits
- Import data from your EDC system or add subjects manually
- Generate invoices & beneficiaries on configurable client-specific or ready- to-use templates
- Void or approve invoices online
- Invoice based on various triggers: visit, procedures, milestones, etc.
- Keep different site budget versions and invoice according to specific version
- Export and report any data on invoicing into sites
- Track unscheduled visits and procedures
- Plan enrollment and compare with the real picture
- Track all patient related data
- Get overall reports on ready to be invoiced, approved and paid activities
- Track invoices status
Investigators & Sites Management
- Feasibility process
- Site performance
- Centralized IRB/LEC submissions and approval tracking
- Investigators, sites, hospitals and out-patient clinics, vendor and regulatory authorities information
- Site team assignment
- Capturing and tracking of all site communication
- Documents tracking (contracts, site regulatory documents, licenses and certificates)
What sets Flex Databases apart
We can deliver a fully functional system in the timeframe from 3 to 10 weeks, depending on the сlient involvement and requirements.
Complete data safety
We have a robust backup & disaster recovery and customer data protection strategy, including distributed data storages around the world.
Flex Databases is compliant with all major international and local regulations such as: ICH GCP E6 R2, FDA 21 CFR Part 11, GDPR, etc.
Easily configure every part of our proprietary platform. The system is fully managed by end users. No installation required.
What they say about us
Electronic Trial Master File
Project Management & Budgeting
LMS & QMS
Have we picked your interest?
Tell us more about yourself and we will organize a tailored live demo to show how you can power up your clinical trials processes with Flex Databases.