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WEB DEMO
  • Home
  • About
    • Our Story
    • The Executive Team
    • Why CRFWEB?
    • Contact
      • Our locations
      • Europe – UK Office
      • India
    • Careers
    • Security and compliance
  • Solutions
    • The EDC process
    • eCRF
    • MedDRA
    • Randomization
    • ePRO
    • eDiary
    • The Clindox App
    • Clindox eLab
    • Innovations Hub
  • Medical Devices
    • Medical Devices Home
    • Introduction to Medical Device Investigations
    • Pre-Licence Investigations
    • Post-Market Investigations
    • Technologies for Investigations
      • technologies for medical device clinical trials
      • ePRO & eDiary for medical device clinical trials
      • EDC for medical device clinical trials
      • The Clindox App for medical devices
      • Clindox eLab
    • Medical Device Regulations
    • Medical Device Resource Centre
    • Clindox for IVD Studies
  • Other Sectors
    • Pharma-Biotech
    • Nutraceuticals
    • CROs
    • Academia
    • Clindox for IVD Studies
  • News

Compliance

Compliance

FDA Compliant Clinical Trials

  • FDA 21 CFR Part 11 Compliant

    Independently audited, (available on request)

  • HIPAA, GDPR, GCP

    Meets all major standards

  • Role based model with full audit trail

    Ensures ‘chinese walls’ in place – task-based role matrix gives complete flexibility on who can access what. Full audit trail on all data amends.

CRFWEB is an FDA compliant clinical trial software application. It complies with FDA 21 CFR Part 11 regulations and is independently audited. It also meets GCP (Good Clinical Practice) standards and helps you comply with GDPR regulations. We have utilised the CDISC ODM (Operational Data Model) as our default coding standard for all aspects of a clinical trial; both Transactional and Snapshot data extracts are available for all datasets. Snapshot and Transactional ODM files can be exported as either XML or .xls files or exported as a SAS Xport file. The CRFWEB App, allows data to be collected safely offline and automatically synced when a secure connection is available.
  • Anonymised subject data
  • Local market servers via Amazon Web Services (AWS)

Subject data is anonymised through the use of subject ID numbers. We are also able to match server locations to local markets to meet local compliance standards. For example, for EU studies, our servers are located within the EU to meet GDPR requirements. Our data is held by Amazon Web Services who adhere to the highest levels of security and compliance.

Please note: The FDA does not issue any compliance certification for clinical trial applications. It is down to the sponsor to demonstrate appropriate study guidelines have been followed. Naturally that necessitates using an FDA compliant database. By this we mean a system built to accepted standards with compliance in mind – so if your study protocols and procedures are compliant, CRFweb will help ensure your study is compliant.

How to demonstrate your EDC application is FDA Compliant?

How do you demonstrate you have FDA compliant EDC? Best practice for this is to use an independent compliance specialist to perform an audit. CRFweb undertakes regular independent audits. Details available on request.

CDISC

Security

  • Local market servers via Amazon Web Services (AWS)
  • Built using CDISC ODM model
  • CSA, HIPAA, GDPR
  • HTTPS data transmissions. 256 bit encryption.
We take security very seriously. The system was designed from the ground-up with security and compliance in mind. We utilize the CDISC ODM (Operational Data Model) as our default coding standard. We comply with FDA 21CFA part 11 regulations and have been independently audited. We also meet the US Health Insurance Portability and Accountability Act (HIPAA), Cloud Security Alliance (CSA) and GCP (Good Clinical Practice) Standards. To give confidential client data maximum security, we use the latest SSL 256-bit encryption technology.
Security-min

Data transmissions use HTTPS and servers are managed with security best practices/standards including the following:

  • SOC 1/SSAE 16/ISAE 3402 (formerly SAS 70)
  • SOC 2
  • SOC 3
  • FISMA, DIACAP, and FedRAMP
  • DOD CSM Levels 1-5
  • PCI DSS Level 1
  • ISO 27001
  • ITAR
  • FIPS 140-2
  • MTCS Level 3

5 Star Reviewed

5 Star rated on Capterra

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

Seeing is believing. Book a web-based demo now.

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Useful Links

  • eCRF
  • eDIARY
  • ePRO
  • MedDRA
  • Randomization
  • Security and compliance

Latest News

June 20, 2022

Meeting the IVDR challenge: digitizing the collection of study data

Read more
March 14, 2022

Covid-19: What has been the impact of the pandemic on India and how have Indian Clinical Trials been affected?

Read more
January 18, 2022

Decentralized Clinical Trials – new kid on the block or a venerable idea resurrected?

Read more

5 Star rated on Capterra

CRFWEB is a clinical trial software application by Clindox

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