Meditrial


Full-service clinical research organization supporting medical device, pharmaceutical and digital health development. Provides clinical trial design and execution (early feasibility to post-market), regulatory strategy and submission support for US/European pathways, market access and reimbursement planning, pharmacovigilance operations, cloud-hosted clinical software and digital data capture, quality system support, and training. Operates internationally with offices in the United States, Switzerland, Italy, Germany and the UK.

Industries

Biopharma
Biotechnology
Clinical Trials
Health Care
Information Technology
Life Science
Medical
Medical Device
Pharmaceutical
Therapeutics
Biotech & Pharmaceuticals
Pharmaceutical and biotechnology
Hospitals and Health Care

Nr. of Employees

medium (51-250)

Meditrial


Products

Cloud-based clinical data capture and operations platform

Integrated web and mobile-capable platform combining EDC, CTMS, CRF builder, data validation, reporting and audit trails to manage multi-site studies and decentralized workflows.

Patient-facing data collection applications

Mobile/web applications for patient-reported outcomes, clinical outcome assessments and remote informed consent with multilingual support and audit trails.

HEU-EFS project deliverables (methodology and open-access portal)

Partner contributions and deliverables for a harmonized EU methodology for Early Feasibility Studies, including pilot testing, monitoring instruments and an open-access information portal.

Catchtrial ePRO

Cloud-based complete data management system featuring an all-in-one CRF, Data Validator, Report Builder, Core Lab images, and Safety Adjudicator for global clinical trials.

Catchtrial EDC

A powerful, intuitive, cloud-based electronic data capture system designed for doctors and patients in modern decentralized clinical trials.

Catchtrial eCOA

An electronic Clinical Outcome Assessment solution that optimizes real-time data collection directly from patients with a simple and intuitive interface.

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Services

End-to-end operational services including protocol development, site selection and qualification, monitoring, data management, biostatistics and safety reporting.

Regulatory assessments, gap analyses, submission preparation and agency meeting support across US and European pathways.

Reimbursement landscape assessments, payer engagement strategy, coding/HTA support and HEOR modelling to support coverage decisions.

Managed PV support including QPPV functions, case processing, periodic/reporting and signal detection.

Provision of local regulatory agents and authorized representative services for market entry and compliance in multiple jurisdictions.

Cloud-hosted EDC/CTMS deployment, patient-facing ePRO/eCOA/eConsent and core lab imaging integrations for decentralized and hybrid trials.

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Expertise Areas

  • Clinical trial management (early feasibility to post-market)
  • Regulatory strategy and submissions (US, EU and UK device pathways)
  • Market access, reimbursement strategy and HEOR
  • Digital health and decentralized trial platforms
  • Show More (7)

Key Technologies

  • Electronic data capture (EDC)
  • Clinical trial management systems (CTMS)
  • ePRO / eCOA / eConsent mobile and web applications
  • Cloud-based data storage and analytics for clinical trials
  • Show More (5)

News & Updates

Practical guidance on MHRA registration and complementary requirements such as conformity assessment, clinical evidence and post-market obligations for Great Britain market entry.

Discussion of how market-entry sequencing and global regulatory strategy affect timelines and costs for medical device launches.

Comparison guidance to help choose appropriate FDA device pathways based on classification, predicates, risk and evidence requirements.

Guidance on building clinical evaluation plans, PMCF and preparing evidence for notified body review under EU MDR Annex XIV.

Listed as a CDISC Gold Member.

Named partner in an EU Horizon-funded project to develop a harmonised methodology for Early Feasibility Studies (HEU-EFS consortium).

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