All-in-One CTMS Software

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

Product sheet PDF

ISO 9001-2015 label certification new version

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

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.

Product sheet PDF

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.

Product sheet PDF

Site Team

Site Card

Submissions List

Features

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

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

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.

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

September 2, 2025

What CROs Should Look for in CTMS and eTMF During a Tender

When preparing a tender for a Clinical Trial Management System (CTMS) and an electronic Trial Master File (eTMF), CROs must choose solutions that meet sponsor expectations and improve operational efficiency while keeping studies inspection-ready. The right choice affects study delivery, compliance, and client satisfaction. Below are the key factors CROs should consider. Regulatory Compliance and […]

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July 31, 2025

How Much ROI Can You Expect from eTMF and CTMS?

A Comparative Look at Europe vs. US Markets In clinical operations, time is money – but how much money can technology really save you? We analyzed the return on investment (ROI) for implementing electronic Trial Master File (eTMF) and Clinical Trial Management Systems (CTMS) based on real-world benchmarks. By modeling savings from reduced manual effort, […]

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July 14, 2025

What is CTMS? Frequently Asked Questions

What is CTMS A CTMS – Clinical Trial Management System is a software solution that facilitates more streamlined management and monitoring of clinical trials. Clinical operations teams like project managers, CRAs, and study coordinators in pharmaceutical firms, CROs, and biotech firms use the tool to oversee everything from site selection and subject recruitment to monitoring […]

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May 12, 2025

Case Study: SOLTI Streamlines Clinical Research with Flex Databases

About SOLTI SOLTI is a non-profit academic research group specializing in breast cancer clinical and translational research. Based in Barcelona, the group unites over 510 professionals across 113 hospitals, including oncologists, pathologists, radiologists, and study nurses. With 42 ongoing studies and a team of 60+ staff members, SOLTI supports clinical trials throughout their entire lifecycle […]

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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.