The process for designing a study, collecting the data, managing that data and reporting on it is straightforward and logical in theCRFWEBapplication.
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
This section pertains to the process for producing an eCRF through our electronic data capture process. The principles are the same whether data collection is EDC or from eSourcedata collection methods via the CRFWEB App including eDIARYand ePRO. The difference requires just some minor design set-up amends and the method of capture varying.
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 (eg. 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 follows 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 CRC, Investigator, Data Manager, Monitor will be in your company settings, however, you can 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 thoughout the whole clinical trial process.
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 of via eSource. 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 saved work as you go.
At set-up you will have designated roles and each key role will see a default dashboard relevant to their needs, that can be customised to their 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 you need in an easily digestable format.
The system is designed for all navigation to be clear and intuitive.
Alternative Data Entry Sources
In addition to manual entry, the system supports bulk entry of a varity of data by excel/csv.
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
Medical Coding – MedDRA, WHODDE
eSource: Direct Data Capture
Subject-led Data Capture – ePRO and eDiary
Decentralised or hybrid trials ready
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:
Validation/Edit Check Report
Visit Status (Study progress percentage – by subject or location)
Study SDV Status
Data Analysis Report
Study Report (Subject Wise)
Study Log Recorded Status Report
Annotated SDTM Excel Report
Medical Coding Reporting
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 "
Elisabeth Liljensten, CEO, Devicia AB
" As a leading Medical Device CRO, we understand the importance of a specialist EDC application in today’s market. I have no hesitation in recommending CRFWEB to our clients."
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."