Meditrial
Clinical research organization providing clinical trial management, regulatory affairs, market access and digital-health solutions. Offers cloud-based clinical data platforms, patient-facing apps, e-learning for regulatory/GCP training, and regional regulatory and site expertise across Europe and the US.
Industries
Nr. of Employees
medium (51-250)
Meditrial
Products
Cloud-based electronic data capture platform
Cloud-hosted EDC system providing electronic CRFs, automated validation, reporting, imaging/core-lab integration and safety-adjudication modules to manage clinical study data.
Patient-facing ePRO / eCOA applications
Mobile and web applications for electronic patient-reported outcomes, clinical outcome assessments and electronic consent workflows.
Clinical trial management system (CTMS)
Operational platform to track study milestones, site performance and study metrics for multi-site trial coordination.
E-learning platform for regulatory and GCP training
Online learning management platform offering courses and live events tailored to regulatory updates and clinical operations.
Cloud-based electronic data capture platform
Cloud-hosted EDC system providing electronic CRFs, automated validation, reporting, imaging/core-lab integration and safety-adjudication modules to manage clinical study data.
Patient-facing ePRO / eCOA applications
Mobile and web applications for electronic patient-reported outcomes, clinical outcome assessments and electronic consent workflows.
Clinical trial management system (CTMS)
Operational platform to track study milestones, site performance and study metrics for multi-site trial coordination.
E-learning platform for regulatory and GCP training
Online learning management platform offering courses and live events tailored to regulatory updates and clinical operations.
Services
Clinical trial management services
End-to-end operational support including study start-up, site activation, monitoring, CRA oversight, patient follow-up and investigator training.
Regulatory affairs and submission support
Preparation and coordination of national and regional regulatory submissions, ethics committee interactions and representation services (EU/US representation and privacy representation).
Medical device compliance and market authorization program
Turnkey support for device technical files, QMS documentation, test-lab coordination and market authorization submissions, including expedited workflows for emergency-use devices.
Digital health and eClinical solutions
Implementation of cloud-based EDC, patient-facing ePRO/eCOA apps, data validation and reporting tools to enable decentralized and hybrid trials.
Trial rescue and risk-assessment workflows
Rapid risk assessment and rescue plan implementation for ongoing trials facing disruption, with operational steps to restore continuity and preserve data integrity.
E-learning and professional training
Regulatory and clinical education courses delivered through an online learning platform for teams and institutions.
Clinical trial management services
End-to-end operational support including study start-up, site activation, monitoring, CRA oversight, patient follow-up and investigator training.
Regulatory affairs and submission support
Preparation and coordination of national and regional regulatory submissions, ethics committee interactions and representation services (EU/US representation and privacy representation).
Medical device compliance and market authorization program
Turnkey support for device technical files, QMS documentation, test-lab coordination and market authorization submissions, including expedited workflows for emergency-use devices.
Digital health and eClinical solutions
Implementation of cloud-based EDC, patient-facing ePRO/eCOA apps, data validation and reporting tools to enable decentralized and hybrid trials.
Trial rescue and risk-assessment workflows
Rapid risk assessment and rescue plan implementation for ongoing trials facing disruption, with operational steps to restore continuity and preserve data integrity.
E-learning and professional training
Regulatory and clinical education courses delivered through an online learning platform for teams and institutions.
Expertise Areas
- Clinical trial management
- Decentralized and hybrid trials
- Regulatory affairs for drugs and medical devices (EU and national pathways)
- Medical device conformity assessment and QMS documentation
Key Technologies
- Cloud-based electronic data capture (EDC)
- ePRO / eCOA / eConsent mobile and web apps
- Clinical trial management systems (CTMS)
- Centralized monitoring and remote monitoring tools