Electronic Data Capture: EDC For Medical Device Clinical Trials

Our EDC for medical device clinical trials provides a range of functions that will ensure the efficient and regulatorily compliant collection of data for your trial or study. These functions will usually include:

Creation of electronic case report forms (eCRFs)
Accurately reflect the needs of the study protocol
Data capture via web browser entry
Simple CRC data entry as a minimum. The capacity to offer direct data capture by subjects or subject data capture by trial staff are increasingly seen as core requirements (provided by CRFWEB)
Data Management capabilities
Securely collect and store subject clinical data, track progress against study milestones and manage data quality
Reporting
Provision of reporting designed to evaluate progess in collecting and cleaning data and to support analysis of the clinical dataset to support study management

The CRFWEB EDC application suite offers all of this functionality, and more. Our extensive experience in medical device studies means that our software platform provides all the tools you’re likely to need to meet regulatory requirements. The following modules are also available and each is fully integrated with our core EDC capability.

Device centric log/form library
Device logs: AE, ADE, SAE, SADE, USADE, randomization for sham controlled studies
Medical dictionary coding (MedDRA)
Dictionary coding is a regulatory necessity for many clinical trials and an advantage for many more. CRFWEB has MedDRA coding integrated into its EDC database.
Study Data Tabulation Model (SDTM)
SDTM fully supported by CRFWEB EDC
Integrated Randomization
Simple, block, stratification, and adaptive methods all supported; market proven, statistician certified. Fully integrated into CRFWEB EDC or as a stand-alone module
Subject-led Direct Data Capture (DDC) via ePRO and eDiary
Browser-based entry or via the Clindox App
Study Staff-led Direct Data Capture (DDC)
Role-based access via browser or the Clindox App

The fully integrated CRFWEB EDC platform offers:

Improved visibility on data collection progress
Streamlined query management
Improved efficiency of SDV
Easy inflight analysis of patient data for safety and efficacy markers

Human error and risk reduction in key study processes
Significant cost reductions on data collection and management activities
Timely completion of studies

CRFWEB will also provide you with the opportunity to discover new scientific, technical and operational insights derived from your data.

To take a more in depth look at what CRFWEB has to offer, click here

eCRF

CRFWEB‘s purpose built eCRF software application is the hub of our EDC

Simple to set up. Simple to use.
Unique role based dashboards allow for simple CRC data entry, or detailed data manager analysis
All the tools you need to manage a trial and report on it
Queries, edit checks, formula, logs, randomization, medical coding, full reporting suite and much more
FDA & MDR compliant, with full audit trial, and secure data
Independently audited to meet FDA & MDR guidelines

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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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