CTMS + eTMF = 10% OFF
This year we celebrate 10 years of Flex Databases contribution into life science. That's why we would like to offer you our bestselling Clinical Trial Essentials for a special price.
Save 10% of your investments
with our CTMS + eTMF bundle
Offer is valid for the first year subscription, for new customers only. Terms & Conditions apply.
Manage all your clinical trials activities
with Flex Databases CTMS
  • Schedule monitor visits, assess CRA performance, and generate any type of visit reports
  • Set up online invoicing, payment rules, and different site budgets
  • Organize all the information on investigators, sites, vendors, therapeutic areas in one place
See all features
Gain complete visibility into all your trial documentation with Flex Databases eTMF
  • Get instant safe access to your trials documentation from any place in the world
  • Ensure constant audit readiness of your TMF
  • Upload documents in seconds, see missing files, review and approve with eSignature, and track everything in real time
See all features
Why Flex Databases solution
We can deliver a fully functional system in the timeframe from 3 to 10 weeks, depending on the сlient involvement and requirements.
Flexible solution
Easily configure every part of our proprietary platform. The system is fully managed by end users. No installation required.
Complete data safety
We have a robust backup & disaster recovery and customer data protection strategy, including distributed data storages around the world.
100% compliance with
global and local regulations, including
21 CFR Part 11
EudraLex Vol 4, Annex 11
GDPR
All Flex Databases' features

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
eTMF
General:

  • Simple TMF template creation and configuration, including DIA Reference Model
  • E-mail blasts from TMF to sites
  • OCR – system recognize text in pictures, scans, photos
  • Online viewing and authoring via browser without download
  • Email alerts
  • Flexible access matrix
  • Web-based: no installation needed
  • The system can be hosted both cloud-based and on-premise
  • Single sign-on functionality is available using LDAP and SAML protocols
  • API is available for use in bidirectional integrations
  • System recognizes special /foreign characters
Upload:

  • Automated filing of documents from CTMS
  • Email upload – send email with attachment directly to eTMF
  • Batch documents upload and download
  • Drag and drop function
  • TMF connected as an external drive through WebDAV protocol
  • Mobile application
Quality control:

  • Adjustable notifications and alerts
  • My Views section – user-defined lists of documents based on metadata groups
  • QC Workflow for all file types, folders and placeholders
  • Chat and comments available for documents and folders
  • Documents review, approve, lock, sign configurable workflow and electronic signature
Reports:

  • Real-time statistics on folders completeness
  • Business Intelligence: widgets and reports
  • Ad-hoc reporting tool for cross-project & cross-module reporting
  • Powerful search engine by various parameters in name and file content
Metadata:

  • Custom metadata setup and management
  • Various metadata structures templates
  • Metadata actions (e.g. notification on expiry date of the document)
  • Dynamic metadata reports
Trusted by the best CROs and pharma
About Flex Databases
We have been developing solutions for clinical trials management since 2011. We are driven by our high mission to make an impact in the Life Sciences industry.

Professionals all over the world are using our platform every day to conduct efficient research and develop effective medicines in a complex and regulated domain.

We have offices in Europe (Prague, Lausanne, and St. Petersburg), the US (Princeton, NJ), and Asia (Nanjing, China).
Want to get a free demo or a quote?
Just drop us a line, and we will show how you can power up your clinical trials processes with Flex Databases.