How FGK CRO automated their clinical trials in 5 weeks

July 26, 2021

How FGK CRO automated their clinical trials in 5 weeks

At the very beginning of 2021 Flex Databases and German FGK CRO signed a contract for CTMS and eTMF implementation.

About FGK

FGK CRO is a full service contract research organization offering a complete range of clinical development and consulting services to pharmaceutical, biotechnology and medical device companies. FGK approaches each project, whether large or small, with dedicated, highly motivated, small teams and a full commitment to achieving and even exceeding your objectives.

FGK Project Scope


Implementation of six Flex Databases modules
Estimated timeframe: 8 weeks
Actual delivery time: 5.5 weeks
Modules:

eTMF
CRA Activity Management
Subject Tracking & Invoicing
Investigators & Sites Management

Project Catalogue
HR Database

Three main stages of implementation

1) System deployment

  • QA environment – for training and user acceptance with mock data
  • Production environment – for real work and data

2) Training

  • Online training session for administrators and end users

3) End user validation support

  • Baseline validation documents for the system in general and per module to be installed, so that a customer could prepare according to their internal validation approach.
  • Customer-specific documentation is issued by Flex Databases, for example, Installation Qualification including Maintenance Plan, UAT Scenarios, release documentation, and training certificates.

FGK implementation timeline

FGK feedback




Martin Krauss, Managing Director of FGK Clinical Research
Why FGK decided to pick Flex Databases as a provider for CTMS and TMF modules?

After an extensive evaluation, FGK chose the CTMS system from Flex Databases. The system convinced with its clear structure and intuitive handling. Both the flexible module for managing the payment of investigators and the possibility for CRAs to work offline with the system are clear advantages. Last but not least, the cooperation with the competent Flex Databases team during the evaluation phase also influenced the purchase decision.

What do you expect to achieve with the implementation of Flex Databases?

„FGK expects to standardize and simplify the management of clinical trials across different phases and sponsors by using the CTMS system from Flex Databases and thus to further increase cost-effectiveness and quality.“

Learn more about Flex Databases CTMS and eTMF or request a free demo: bd@flexdatabases.com.

Blog

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, […]

July 29, 2025
The Flex Databases team is looking for a QA Engineer / Tester. 

📍Remote 💼Full-Time We are driven by our high mission to make an impact in the Life Sciences industry. We provide flexible e-Clinical software systems for Clinical Research Organizations (CROs) and pharmaceutical companies.  We work globally with clients all over the world, with our own offices located in the Czech Republic, Switzerland, Turkey, and the US. […]

July 22, 2025
Electronic Data Capture – Everything You Need To Know

What is Electronic Data Capture? Electronic Data Capture (EDC) is an electronic system applied to clinical trials for capturing, managing, and storing patient data. Instead of paper-based forms, investigators enter clinical trial information directly into a secure, web-based site. EDC systems validate data integrity, reduce errors, and automate the data collection process – accelerating clinical […]

Data Hosting with Confidence – Flex SaaS for Clinical Trial Environments 

At Flex Databases, we deliver a SaaS solution purpose-built for clinical trials – offering global accessibility with full transparency and control over where your data resides.  Not a Public Cloud. A Dedicated SaaS Platform You Can Trust.  Flex Databases is an EU-based company operating globally and trusted by life sciences organizations for secure, validated SaaS […]

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.