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.
Site Health report
Visit cabinet
Visit calendar

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.
Dashboard
Invoices
Site Budgets

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.
Site Team
Site Card
Submissions List

Features

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 Intellig ence 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 her logs
  • Templates designer for all documents – full flexibility with confirmation letters, follow-up letters, site visits reports d 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)
  • Reports

What sets Flex Databases apart

Easy implementation

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.

Full compliance

Flex Databases is compliant with all major international and local regulations such as: ICH GCP E6 R2, FDA 21 CFR Part 11, GDPR, etc.

Flexible solution

Easily configure every part of our proprietary platform. The system is fully managed by end users. No installation required.

What they say about us

John Douglas Snowden
Senior Vice President of Technology Innovation at NCGS, Inc.
NCGS has partnered with Flex to utilize nearly the entire suite of cloud-based modules Flex has to offer for the industry. NCGS believes in Flex’s vision for their platform as it so closely ties to our own ideals of uniformity and simplicity in operations and the delivery of true quality.
Tameo Kobayashi
Chief Innovation Officer, Director, Business Innovation Dept., CMIC HOLDINGS Co., Ltd.
Flex Databases system is very flexible and user friendly. In addition, most importantly the team have much much flexible ways of thinking! I am very proud that we did choose Flex Databases as our platform in CMIC APAC offices.
Joshua Baisley, H.B.Sc.
VP, Clinical Design and Delivery
As we have begun the installation process for Flex Databases system for use with the Clinical Trial Management group, the team at Flex Databases have made this process efficient and organized along with answering any questions that come up internally and jumping on additional meetings with our team to ensure that everything is understood throughout the set up and training process.

CTMS blog

Minimising human error in clinical study with Flex Databases CRA Activity Management

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?

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AXIS Clinicals selected Flex Databases CTMS & eTMF to streamline service areas

`”AXIS is implementing Flex Databases CTMS as we see this as an excellent full-service software that will enable us to have management of all our research systems under one platform.”

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Managing multiple-currency studies with Flex Databases

International clinical trials, in most cases, mean multiple currencies and exchange rates throughout all financial operations. Flex Databases offers a simple yet elegant solution to effectively manage multi-currency projects.

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Site Health Assessment as a part of Risk-Based Monitoring

Site Health Assessment is a process of differentiating sites to achieve a more targeted monitoring strategy. Top-performing sites can be monitored less thoroughly, whereas low-performers need more intensive monitoring and detailed attention. 

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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.