Electronic data capture, query management, biostatistics, medical coding and database lock for clinical investigations and PMCF studies across France, the UK and Germany. Every record managed to 21 CFR Part 11 and GDPR, so your data holds up to Notified Body review.
Awarded at the xShare Open Call for Clinical Research, organised by EUCROF and co-funded by the European Union, recognising our work in clinical research innovation.
Platinum Award · xShare Open Call for Clinical Research, organised by EUCROF and co-funded by the European Union. Amsterdam, 2 February 2026.
Whatever brings a MedTech sponsor to clinical data management for medical devices, Eclevar maps directly to the brief: clean data capture, a statistics and coding partner, or audit-ready compliance.
Database and eCRF design, electronic data capture, built-in edit checks and query management, so clean data is built in from first patient in.
See client results ›Reconciliation, medical coding, statistical analysis plans, CDISC and SDTM datasets and database lock, led by a dedicated data and biometry team.
Meet the data team ›Validated systems with full audit trails, access control and electronic signatures, aligned to 21 CFR Part 11 and GDPR, so records hold up to Notified Body review.
Read the data FAQ ›
Restructuring Japanese clinical documentation into the language and rigor European Notified Body reviewers expect, for the EEG-1200K. "The team responded promptly and flexibly," reports the Nihon Kohden product manager.
Dedicated clinical evaluation and post-market evidence generation for advanced dental and restorative technologies.
A multi-centre reimbursement clinical study in the UK, generating the evidence required for market and payer access.
Five focused franchises, each with clinical, regulatory and data leads who know the device class and its endpoints inside out.
Structural heart and Class III, our lead franchise.
Spine and implants, built by a former NB reviewer.
Restorative and dental device evidence.
Neuromodulation and neuro-implants.
Advanced wound care and regenerative devices.
Most data problems are discovered at database lock, when they are expensive to fix. Eclevar changes the order of operations, cleaning as it captures.
Former Notified Body reviewers, competent-authority and industry veterans, plus a dedicated clinical data and biometry team, all under one roof.
30 years in biometry, leading clinical data systems, statistics and database lock.
Former senior reviewer at TUV SUD. Specialist in Class III implants.
Clinical evaluation methodology for cardiovascular devices and complex implants.
Direct expertise in Notified Body Q and A cycles for high-risk Class III devices.
Site qualification and ISO 14155:2020 data integrity across studies.
Supports study coordination and client delivery across European programs.
Eclevar runs clinical activities from offices in Paris and Erfurt, across a European study-site network, and extends to global markets through device-manufacturer partners.
Headquarters: 231 rue Saint-Honore, 75001 Paris, France · Eclevar GmbH, Erfurt, Germany
Tell us about your device, endpoints and target markets. We will map the data plan and give you an itemised, costed scenario before you commit.
Book a free data scoping call ›