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All-in-One CTMS Software

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

Product sheet PDF
compliant with FDA
ISO 27001_2022

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.
Product sheet PDF
Site Health report

Site Health report

Visit cabinet

Visit cabinet

Visit calendar

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.
Product sheet PDF
Dashboard

Dashboard

Invoices

Invoices

Site Budgets

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.
Product sheet PDF
Site Team

Site Team

Site Card

Site Card

Submissions List

Submissions List

Features

Visit calendar
  • 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
Dashboard
  • 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
Submissions List
  • 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 They Say About Us

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.

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.

Craig Winter

CIO, Agenus Inc.

I have been with Agenus for over 26 years. Over those 26 years, our Flex CTMS and TMF implementation is the smoothest and fastest implementation of a validated IT system we have done.

Cheryl Marron

Manager Clinical Operations

We were searching for a flexible yet straightforward eTMF solution for one of our biotech clients. We have been working with Flex Databases for our internal project management and budgeting and their eTMF solution also convinced us. The Flex Databases team was incredibly helpful with setting the system up in no time.

Ulrike Schorr-Neufing

Director Personnel & Qualification

We have been using Flex Databases software for about 2.5 years now. One major advantage of Flex Databases CTMS is the ability to create specific reports ourselves. Additionally, we value that our feature requests are taken seriously by Flex Databases and added to their development roadmap. We also benefit from their customer-specific configuration service.

Martin Krauss

Director of FGK Clinical Research

FGK selected Flex Databases for CTMS and TMF due to clear structure, intuitive interface, flexible investigator payment module, offline access for CRAs, and positive cooperation with the Flex Databases’ team.

Simon Rückinger

Managing Director at Metronomia Clinical Research GmbH

We were searching for a flexible yet straightforward eTMF solution for one of our biotech clients. We have been working with Flex Databases for our internal project management and budgeting and their eTMF solution also convinced us. The Flex Databases team was incredibly helpful with setting the system up in no time.

Maya Bhattacharya

Manager, Global Regulatory Affairs Operations

We knew Flex Databases was a game changer, providing confidence to what we could do next within the Clinical space, considering our trials/patients. SPARC choose Flex Databases due to system flexibility and checking the boxes for ALL of our major requirements. We also wanted the latest and greatest technology considering the long-term advantages of having one solution with the increased possibilities of integration.

Lídice Vidal

Chief Clinical Օperations Officer

We have made a journey of almost two years now, since we were exploring new vendors to change our CTMS system in May 2022, until the deployment of the system last March 2024. It would not be possible without the kind and patient support of Flex team! All the team we have encountered during this time have listened attentively to our needs and doubts, have perfectly understood them, and have always provided us with new options and possible solutions.

Have questions?

Drop us a line and we be happy to answer all your questions

100+

Clients

20 000+

Daily users

10M+

Documents

2 000+

Clinical trials

30+

Countries

CTMS Blog

How to Integrate CTMS with EDC
November 14, 2024
How to Integrate CTMS with EDC

Clinical Trial Management Systems (CTMS) and Electronic Data Capture (EDC) systems are critical to the effective management of clinical trials. By integrating CTMS and EDC, organizations can streamline processes, enhance data quality, and improve overall efficiency. Here are five key tips to ensure a successful CTMS and EDC integration. Effortless Integration of Flex Databases CTMS […]

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Cloud-based CTMS vs. On-premises CTMS: Which is Right for Your Clinical Trial Management?
September 25, 2024
Cloud-based CTMS vs. On-premises CTMS: Which is Right for Your Clinical Trial Management?

Two popular models dominate the Clinical Trial management System landscape: Cloud-based and On-premises CTMS. Both have their merits, but choosing the right option depends on several factors, including cost, scalability, security, and operational requirements. This article will explore the differences between Cloud-based Clinical Trial Management  System and on-premises CTMS, helping you determine which solution best […]

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Challenges in the Implementation of CTMS
September 18, 2024
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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Difference Between CDMS and CTMS
August 1, 2024
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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Contact us

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.