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.
Top prize at the xShare Open Call for Clinical Research, organised by EUCROF and co-funded by the European Union, awarded to Eclevar MedTech and its Milo Health platform.
Platinum Award · xShare Open Call for Clinical Research, organised by EUCROF and co-funded by the European Union. Amsterdam, 2 February 2026.
Device makers rely on Eclevar to capture, clean and lock the clinical data behind their EU MDR evidence. Read all client success stories.
Data management is only as good as the people who design the eCRF and defend the database lock. Two of them lead every Eclevar data programme.
Chief Data Officer with more than 30 years in biometry, leading clinical data architecture, statistics and database lock across Eclevar's medical device studies. He owns the data model end to end, from eCRF and database design through edit-check strategy, statistical analysis plans and CDISC and SDTM datasets, to the locked, submission-ready database. His experience spans structural heart, orthopedics and complex Class III investigations, where endpoint definitions and data quality decide whether a study survives Notified Body review. For MedTech sponsors, he is the guarantee that statistics and regulatory review both start from clean, defensible numbers.
Senior Clinical Data Manager with more than 10 years in clinical data management, including over five years at the Cardiovascular European Research Center (CERC), where she led the data management team on cardiovascular device studies. She has designed and validated eCRFs across multiple EDC platforms (Cleanweb, Clinical Studio, Castor), with deep expertise in data validation, consistency-check programming (SAS, R) and database lock for complex clinical investigations. A biomedical engineer (ISIFC) with a Master's in biomedical information processing, she is a major asset for MedTech manufacturers facing the clinical-data requirements of the European MDR.
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 ›Most data problems are discovered at database lock, when they are expensive to fix. Eclevar changes the order of operations, cleaning as it captures.
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.
Restructuring Japanese clinical documentation into the language and rigour 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.
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
Whitepapers, client testimonials and publications produced by our teams and partners (BSI, TÜV SÜD, RegenLab).
Written with Notified Body BSI: a practical reading of the clinical evidence expectations under EU MDR 2017/745, the same evidence your clinical data has to support.
Eclevar manages RegenLab's PMCF programme on chronic wound devices. This is a randomized study of 160 patients across 14 sites in 5 EU countries, covering both diabetic foot ulcer (DFU) and venous leg ulcer (VLU) indications. The partnership combines Eclevar's ISO 14155 clinical expertise with the Milo Studio platform to deliver post-market clinical follow-up evidence, from protocol design through to final study report.
« Eclevar, with its tailor-made approach and advanced Milo Studio platform, represents a major strategic asset. »
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.
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