Flex EDC

Flex EDC – ensure fast capturing and reviewing data of your clinical studies in a user-friendly interface

Create, manage and control your eCRFs

  • Have a complete track of your study at one place
  • Speed-up your study start-up timeline – only 3 weeks to set up Flex EDC for your trial
  • Arrange fast and easy completion and check of your eCRFs
  • Control all the visits and eCRF fulfillment in one screen – a convenient and straightforward semaphore system enables to have a glance at all patients' visits and eCRFs completion
  • Use a fully validated and 21 CRF part 11 compliant system – Flex EDC is developed in compliance with all the requirements: GCP E6 R2, 21 CRF part 11, GAMP5, HIPAA, etc.
Subject View
EDC Dashboard
Visit View

Sprint through building your eCRFs

  • An intuitive eCRF builder enables to create forms in a few minutes
  • Drag-and-drop approach for a simple eCRF building
  • All the fields you might need are already in the system
  • Online set-up of calculations and dates
eCRF builder
Visits
Vital signs

Manage your stock and patient randomization with IWRS

  • Save your time and money – IWRS is already a part of our Flex EDC: you will not be charged for it separately and always have access to the module
  • Use one of 4 randomization types in accordance with your study design
  • Randomize your patients by one click
  • Control your stock and IMP distribution
Informed Consent Signature

Supply your patients with our ePRO

  • Increase patient recruitment by simplifying patient’s diaries fulfilment
  • Have access to patient diaries in real-life time
  • Prevent patient dropout by managing their outcomes in real time
ePRO

Minimize possible mistakes of sites and investigators

  • Provide your sites and investigators with a separate system and an immediate data flow to your major platform
  • Create mass queries in Flex EDC and use any templates you need
  • Arrange automatic fulfilment of the fields with possibly calculated data, excluding any potential mistakes
  • Let your investigators control visits with a calendar for every subject
Dashboard

Features

Simplifying process for Sponsor

  • Unlimited clinical trial size – up to 500 000 subjects included in one study during beta testing
  • Prompt and easy eCRF creation
  • Distribution of roles in just one click
  • Built-in medical coding WHODrug, MedDRA, ATC, and ICD
  • Export to CDISC SDTM, SAS, XML, and Module
  • Smart search within EDC
  • Semaphore system to quick assessment of processes completion
  • Templates for raising queries
  • Compliance with GCP E6 R2, 21 CRF part 11, GAMP5, HIPAA
  • Full-trial KPI report

Simplifying process for Investigators

  • Fast access to the system through a dedicated portal for Investigators
  • Quick and clear data input
  • Easy to add subjects in the study
  • Calendar of visits for every subject and the trial in general
  • Templates to close queries in a few seconds
  • Simple navigation system with ability to find a subject in one click

Simplifying process for patients

  • ePRO App for patients to simplify diary maintenance
  • User-friendly & supportive interface and diary management process
  • Branding for mobile apps & website
  • Fast access to patient’s diary
  • Integration with wearable devices, such as fitness trackers and smart watches

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.

More about EDC

Flex Databases – your new powerful data house

With the launch of Flex EDC, you will be able to cover all the aspects of the clinical trial process and beyond within one platform.

Learn more
Synchronizing safety data from EDC/eCRF with Flex Databases Pharmacovigilance

Flex Databases is ready to arrange the automated data flow from any eCRF/EDC used by Sponsor or CRO to our Pharmacovigilance module.

Learn more

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.