Capturing high volumes of patient and study data from case report forms, patient reported outcomes and patient surveys or questionnaires can be a time consuming and labour-intensive task.
eClinical is a data capture system that enables you to process high volumes of paper trial forms with clinical efficiency, without compromising accuracy, reliability or audibility.
Used as part of an FDA 21 CFR part 11 compliant system, eClinical is a viable, high-quality and lower cost alternative to the large and complex EDC systems used in clinical trials.
As new drug and product development can take many years and cost millions, you cannot underestimate the importance of your document management and form processing to ensure everything is done right the first time.
However big or small the trial, it is prone to human error. As many involve a large number of trial patients and investigator sites, you have to be able to rely on your data collection processes. The simplicity of eClinical is such that any member of your clinical trials team with basic IT literacy skills can be trained up to take responsibility for designing data capture forms and system administration.
Walkthrough the steps involved to get better grasp of what it can do for you.
attractive and functional questionnaires, surveys and case report forms with the easy to use CRF designer to meet trial protocol and standard operating procedures (SOP)
patient data whatever the method of delivery (fax, paper, web or eMail) for maximum efficiency
data using OCR, ICR, OMR, barcode, and logo recognition
the data to ensure only accurate results are captured
data to the Trial Master File (TMF), clinical trial management software (CTMS) or related databases and applications for true integration
and retrieve forms securely and conveniently for total accountability
A WYSIWYG form designer allows you to create, configure and deploy forms (e.g. CRFs, PROs, patient follow-up and questionnaires) with re-usable fields, sections and design elements.
Either design new paper-based survey forms or capture your existing CRF designs by overlaying data entry fields on top of your current structure.
Capture clinical data from multiple sources (MFPs, scanners, fax, eMail, web and smartphones) in both centralised and distributed capture environments.
eClinical captures your data with clearly defined and consistent rules with non-compliant data flagged for human verification.
Once content is verified, it can be exported into your TMF or eStore for archiving and retrieval. Alternatively, it can be exported to different formats including Excel, CSV, XML, SQL or SPSS.
eClinical can be used as part of an FDA 21 CFR Part 11 compliant system to streamline clinical trials processes and remain compliant.
eClinical allows paper CRF’s to be exported from the CRF Designer as dynamic PDF or HTML forms for end-users to complete on-screen and submit electronically back to the verification module.
Allow your trial team to focus on more productive tasks rather than time-consuming document sorting and manual data entry.
You can save on postage and transportation, scanning bureaus and end your need for expensive storage space.
eClinical reduces time spent on study build, medical data entry, and query management, resulting in accelerated data capture.
Case report forms, paper questionnaires and patient surveys are scanned by the site with a digital copy immediately available and stored in records management software.
eClinical accelerates the time needed to build and release a new study, which can have a significant benefit in reducing your time to market.
Reduce data entry errors by extracting data from scanned documents using OCR, ICR, OMR, and barcode technologies. Only invalid or unrecognisable fields are shown to human operators.
eClinical is not just an off-the-shelf data capture system; it is bespoke and tailored from off-the-shelf components. This means you get a solution that does exactly what you need, is not bloated with extra functionality and you get peace of mind that your mission critical application is built on a solid and well supported framework.
Keele Clinical Trials Unit (CTU) specialises in the development and delivery of high-quality multicentre clinical trials, testing treatments and health services, as well as other high-quality clinical studies, including large epidemiological studies, in primary and secondary care settings with the aim of improving patient care.
Keele CTU has a well established track record of research delivery particularly in the areas of primary care research. Operational services such as trial management, software development, data management and statistical services are provided to support the delivery of high quality, ethically and clinically relevant research. Staff within the CTU have a strong knowledge base of research methodology and Trust/Primary Care procedures. They have an understanding of the needs of the Sponsor, Investigator and the Participants.
To facilitate the required data collection for their studies, Keele CTU uses TeleForm software to scan, verify and export paper questionnaires and case report forms directly into a database.
eMail: CTU operations
Website: Keele CTU website
The London School of Hygiene and Tropical Medicine (LSHTM) and MenAfriCar are using eClinical to study meningococcal meningitis carriage in households in Africa and document the impact of a new vaccine (PsA-TT) on reducing transmission of serogroup A meningococcal meningitis.
The data capture software pre-populates the paper forms prior to collecting data from thousands of study participants across Africa. The forms are scanned, indexed and exported to the main trial database in London.
GIG Cymru / NHS Wales is using eClinical to scan paper surveys into a database.
The data capture system scans, verifies and exports paper case report forms from the ‘All Wales Medication Safety Monitoring’ trial into a database.
Used to support university clinical trials, eClinical is scanning clinical assessment forms for medical students at the University of Plymouth.
King’s College London is using eClinical to scan, verify and export paper case report forms from several trials, including the SentiMAG multicentre study, directly into a database.
Overall, this system works really well for us. This is a great way to capture patient data and scan it into a usable database with out manually entering all their answers.
Our studies can have a lot of forms, and having the ability to scan everything into a database with TeleForms has made everything much more efficient.
We use TeleForm to collect data for clinical trials.
It’s a very solid system, allows to create forms that fit our studies while keeping them clear and easy to fill out for participants.
eClinical is a powerful solution that allows for data capture from paper and electronic case report forms.
Built on a solid framework, eClinical is configured to do exactly what you need and is not bloated with extra functionality.
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