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Flex Databases

Flex EDC

Healthcare & Pharmaceuticals | Clinical Trial Management Software

Product Overview

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 FlexEDC 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.

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

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

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

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

Specifications

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

Build-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

Product Reference

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Product Overview

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 FlexEDC 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.

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

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

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

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

Specifications

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

Build-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

Product Reference

Add Review

Quality
Facilities
Price
Service
Your Score

Location

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