The CRFWEB EDC Process

CRFWEB: EDC for Clinical Trials

The process for designing a study, collecting the data, managing that data and reporting on it is straightforward and logical in the CRFWEB application.

Design a study for any method of Data collection
EDC or eSource. Direct data capture by site or subject.
The features you need, are all integrated
Medical coding (MedDRA), Randomization, eTMF, eConsent
Decentralised or hybrid trial ready
All built the same way within one integrated system

The Study Process with CRFWEB

Producing an eCRF is essentially the same process whether data collection is via standard browser-based EDC or from data collection methods like eDIARY and ePRO via the Clindox App. There are just some minor design and set-up amendments depending on the method of data capture deployed.

Study Design

It couldn’t be simpler. Just hit ‘Create a new CRF’ from your dashboard and you will be taken through the process step by step.

Add and edit the key components of your study (e.g. Medicine log or incident log) from our library
The system structures all interview questions on a visit by visit basis
Questions related to a specific visit to the subject can be grouped into multiple sections to accommodate complex or multiple questions as appropriate
Create your own questions or add them from a template or question bank
Add edit checks and formula as required
The system offers multi-language capability, which can be set at the design stage
Once your first CRF has been set up, you can use it as a template for future work and edit as required

Defining access roles

CRFWEB featues a dynamic approach to role-based access controls. You determine the number of roles and their defined capabilities when setting up a study. Common default roles such as Clinical Research Coordinator (CRC), Investigator, Data Manager, Monitor will all be available in your company settings as standard, however, you will be able to rename, add and define roles to meet studies specific needs and ensure all those involved in the process have the correct access and authority for the EDC process.

Individual users can also have multiple roles within their profile as required. In short, you have complete control of who has access to what data thoughout the whole clinical trial process.

Data Capture

The data capture element within CRFWEB is a simple process. At study set up you will have dictated whether data entry is planned to come via standard entry into the eCRF through a web browser, or via direct data capture from subjects using the Clindox App on their own device. Whether the data is being entered directly by a CRC on their tablet, or a subject on their mobile, everything is designed to create a simple and engaging customer experience.

Users are taken through a step-by-step process for data entry and you can save and review work as you go.

At set-up you will have designated key roles and each role will access a default dashboard relevant to their specific needs – and which can be customised to suit individual preferences. Whether this a CRC looking for quick and simple data entry options, an investigator managing queries or a data manager monitoring trial progress, the system is designed to provide the information needed in an easily digestable format.

The system has been designed to ensure that all navigation is clear and intuitive.

Alternative Data Entry Sources

In addition to manual entry, the system supports bulk entry of a variety of data in excel & csv formats.

See for yourself how simple data entry is on CRFWEB

Managing Your Study

Critical in any EDC application for clinical trials is the ability to monitor progress and troubleshoot. CRFWEB has a dedicated query management and resolution tool, enabling different roles/users to troubleshoot queried data within their security level. Data Managers and monitors can analyze data input once entered, raise an issue log to query questions or groups of questions, filter queries to meet specific requirements and audit via issue reports. Notifications can be toggled on or off as desired.

As an FDA compliant system built to GCP standards using the CDISC model, naturally all data entry and amends are captured via audit trail.

The CRFWEB Checklist

Randomization
Medical Coding – MedDRA
eSource: Direct Data Capture
Subject-led Data Capture – ePRO and eDiary
SDTM
Double-Data Entry
Decentralised or hybrid trials ready

Reporting

CRFWEB has a comprehensive reporting system designed to produce a variety of standard reports a trial manager may require to first validate trial set up and then keep control of trial progress and results. These include:

Annotated CRF
Validation/Edit Check Report
Onboarding Report
Visit Status (Study progress percentage – by subject or location)
Study SDV Status
Query List
Data Analysis Report
Study Report (Subject Wise)
Study Log Recorded Status Report
Medical Coding Reporting
Annotated SDTM Excel Report

Post-Approval-and-Post-Marketing-Research

5 Star Reviewed

What our clients say

Maria Galligan, PMD Solutions

" The Clindox team have been an incredible support and are always available to help in any way they can."

Dr Salvi, CRF Health, India

" The time and cost saving is really significant. We're very happy with the performance or CRFweb and I wouldn't hesitate to recommend it."

Nigel McLean, Cytosystems, UK

" CRFWEB eCRF, plus their helpful and accommodating staff, helped us quickly set up and personalize, with quick turn-around times of modifications, exactly what we, the clinical staff, and statistical consultants demanded, all at an affordable price "

Kelly Seamans, Atlantia

" The Clindox (CRFWEB) team are dedicated and enthusiastic about accommodating the unique requirements of each individual study and are great value for money."

Dr Satish Kumar, G7 Synergon

"Our international CRO business has utilized Clindox's integrated randomization module and Kit Management. The functionality provides everything we need, and having key trial components integrated into one system is a huge advantage to us in terms of trial efficiencies. Having both randomization and kit management capabilities, aligned with the EDC really simplifies the whole process and significantly reduces the time and effort required to manage our studies and keep control of our processes and inventory. "

Next Steps

For a quick system overview, click here

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