All-in-One CTMS Software

One system for clinical development process and beyond. Evidence-based decisions. More information – less efforts.

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 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)
  • 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

CTMS Implementation challenges
Challenges in the Implementation of CTMS

Implementation of a Clinical Trial Management System (CTMS) can streamline operations, improve data management, and enhance trial oversight. However, the process also brings a range of challenges that must be addressed to achieve a successful implementation.  These challenges often stem from technical and human factors, including data quality, system integration, and regulatory demands. Identifying these […]

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top ctms 2024
Flex Databases Recognized as a Top Clinical Trial Management Provider for 2024

We are excited to share that Flex Databases has been named a Top Clinical Management Provider for 2024 by Life Science Review. This prestigious recognition highlights our strong reputation and the trust placed in us by both customers and industry peers, reflected in numerous nominations from Life Science Review subscribers. This award comes at a […]

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CDMS vs CTMS
Difference Between CDMS and CTMS

Clinical Data Management Systems (CDMS) and Clinical Trial Management Systems (CTMS) are two key tools that play crucial roles in this process. While they might sound similar, they serve distinct purposes and offer different functionalities.  What is a Clinical Data Management System (CDMS)? A Clinical Data Management System (CDMS) is a specialised tool designed to […]

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6 Ways To Improve Clinical Trials Management 
6 Ways To Improve Clinical Trials Management 

Clinical trials play a crucial role in medical progress, yet effective management is essential to maximize their impact. Administrators must craft a thorough strategy to enhance how trials are managed. Here are five strategies to transform clinical trial management, providing administrators with the tools and insights needed to navigate healthcare research challenges effectively. Simplify planning […]

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Get in touch to discuss compliance, implementation, demos, pricing

We are here for all of your questions! 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.