CRFWEB
CRFweb by Clindox is a provider of advanced software and service solutions for clinical data collection, management, and analysis. They focus on supporting regulatory compliance and innovation in clinical trials, especially for medical device investigations. Their offerings include integrated applications such as eCRF, ePRO, eDiary, MedDRA coding, and randomization modules, tailored for the medical device sector and compliant with MDR and FDA regulations. They aim to create better studies through human-centered, cost-effective, and flexible clinical data management solutions, with a strong emphasis on innovation, customer service, and global reach.
Industries
Nr. of Employees
small (1-50)
Products
Electronic Data Capture (EDC) platform
Cloud-hosted EDC platform providing integrated eCRF design, mobile capture, reporting, audit trails, dictionary coding, randomization and eTMF support for regulated clinical and post-market investigations.
Mobile data-capture application
Cross-platform mobile application for participant and site data capture, supporting offline operation, multimedia attachments, notifications and configurable question formats for ePRO/eDiary/eCOA use cases.
Electronic Data Capture (EDC) platform
Cloud-hosted EDC platform providing integrated eCRF design, mobile capture, reporting, audit trails, dictionary coding, randomization and eTMF support for regulated clinical and post-market investigations.
Mobile data-capture application
Cross-platform mobile application for participant and site data capture, supporting offline operation, multimedia attachments, notifications and configurable question formats for ePRO/eDiary/eCOA use cases.
Services
Study setup and implementation
Rapid study build and configuration for clinical investigations with options for vendor-led or sponsor self-build, including eCRF design and study configuration.
Data migration and rescue-study services
Import and migration of existing study data, conversion of paper trials to EDC, and setup of rescue studies while preserving integrity and audit trails.
Randomization and kit-management integration
Integration and configuration of randomization schedules and kit/inventory management aligned with the EDC to streamline supply control and trial logistics.
Regulatory and compliance configuration for device studies
Configuration of study workflows and data exports to support MDR/IVDR/FDA requirements, PMCF/PMS studies and ISO 14155-aligned principles.
Training, customer support and business-continuity services
Remote training for site staff, ongoing customer support via phone/email/chat, and business-continuity planning to maintain trial operations during disruptions.
Compliance validation and audit support
Provision of system compliance evidence, validation documentation and support for independent specialist audit reviews to demonstrate alignment with 21 CFR Part 11, GCP and relevant data standards.
Study setup and implementation
Rapid study build and configuration for clinical investigations with options for vendor-led or sponsor self-build, including eCRF design and study configuration.
Data migration and rescue-study services
Import and migration of existing study data, conversion of paper trials to EDC, and setup of rescue studies while preserving integrity and audit trails.
Randomization and kit-management integration
Integration and configuration of randomization schedules and kit/inventory management aligned with the EDC to streamline supply control and trial logistics.
Regulatory and compliance configuration for device studies
Configuration of study workflows and data exports to support MDR/IVDR/FDA requirements, PMCF/PMS studies and ISO 14155-aligned principles.
Training, customer support and business-continuity services
Remote training for site staff, ongoing customer support via phone/email/chat, and business-continuity planning to maintain trial operations during disruptions.
Compliance validation and audit support
Provision of system compliance evidence, validation documentation and support for independent specialist audit reviews to demonstrate alignment with 21 CFR Part 11, GCP and relevant data standards.
Expertise Areas
- Clinical trial management
- Digital health and mobile data capture
- eClinical systems design and deployment
- Regulatory compliance for medical devices (MDR/IVDR/FDA) and ISO 14155-aligned data capture
Key Technologies
- Electronic data capture (EDC)
- ePRO / eDiary / eCOA
- Mobile BYOD and provisioned-device capture
- Offline data capture and synchronization