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Platinum Award, EUCROF & European Commission, 2026

Biostatistics built for EU MDR medical device trials.

Eclevar MedTech is a biostatistics CRO for medical devices in Europe. Statistical Analysis Plans, sample size and power, adaptive and Bayesian design, CDISC SDTM and ADaM, and validated programming, written in the language Notified Body reviewers expect.

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30 yrs
in clinical biometry
21 CFR
Part 11 validated workflow
SDTM
and ADaM CDISC datasets
Fewer
patients through smarter design
Sebastien Meier Piantanida, Chief Data Officer and Head of Biometry at Eclevar MedTech
Chief Data Officer & Head of Biometry

Sébastien Meier Piantanida

Thirty years in clinical biometry and the architect of the MILO EDC, built to 21 CFR Part 11 standards. He leads Statistical Analysis Plans, sample size strategy and CDISC delivery for medical device trials.

Biometry × MILO Meet the team

Co-funded by
the European Union

Platinum Award, xShare Open Call for Clinical Research, organised by EUCROF and co-funded by the European Union. Amsterdam, 2 February 2026.

Statistical outputs delivered to EU MDR 2017/745 ISO 14155:2026 21 CFR Part 11 CDISC SDTM CDISC ADaM GDPR
What we do

Three reasons MedTech sponsors hand us their statistics.

From the first sample size question to the final dataset, biometry led by people who know what a reviewer needs to see.

Statistical Analysis Plans and sample size

Device-specific SAPs, primary and secondary endpoints, hypotheses, non-inferiority and equivalence margins, and a sample size and power calculation you can defend.

SAPPower analysisNon-inferiorityEndpoints
Discuss your endpoints

Adaptive and Bayesian design

Sample size re-estimation, interim analyses and DSMB support, with Bayesian methods and historical borrowing where appropriate. Fewer patients, without losing rigour.

AdaptiveBayesianInterim analysisDSMB
Explore adaptive design

Statistical programming and CDISC delivery

SAS and R programming, tables, listings and figures, CDISC SDTM and ADaM datasets, and the statistical sections of the clinical study report, validated and reproducible.

SASRSDTMADaMTLF
See data management
What you receive

Every statistical deliverable, in one accountable team.

From protocol to clinical study report, the statistical chain stays under a single biometry lead.

Statistical Analysis Plan

Endpoints, hypotheses, analysis sets and methods, written for the device and the reviewer.

Sample size & power

Defensible calculations anchored to historical device data, at P25, P50 and P75.

Randomization & blinding

Allocation schemes, stratification and blinding, generated and documented for audit.

Interim analyses & DSMB

Pre-specified interim looks, stopping rules and independent data monitoring support.

Programming & TLFs

SAS and R programming with SDTM and ADaM datasets, tables, listings and figures.

Statistics trusted by global medical device manufacturers

RegenLab NIHON KOHDEN SHOFU Meril
Client success stories

Statistics that hold up under review.

Programmes delivered for manufacturers in wound care, neuro, renal, dental and cardiovascular devices.

RegenLab and Eclevar MedTech review, statistical design for wound care PMCF studies
Video · Adaptive design

Less patients, more data: the RegenLab experience.

Statistical design that gets more out of every patient. Eclevar manages the upcoming PMCF studies on chronic diabetic foot ulcer devices for RegenLab, a tissue-engineering specialist present in 160 countries.

"Eclevar, with its tailor-made approach and advanced MILO Studio platform, represents a major strategic asset."Antoine Turzi, CEO, RegenLab

Eclevar MedTech and Nihon Kohden team, structuring clinical evidence for EU MDR Notified Bodies
Class IIa EEG · Japan to EU MDR

Documentation logic reviewers accept.

Restructured Japanese clinical evidence and analysis into the rigour European Notified Body reviewers expect for the EEG-1200K.

"Eclevar shared their expertise so we could create documentation perfectly adapted to our needs. The team responded promptly and flexibly."Product Manager, Nihon Kohden

Eclevar MedTech team with Shofu Inc, evidence generation for dental devices
Dental · Post-market evidence

Shofu Inc.

Clinical evaluation and post-market evidence generation for advanced dental and restorative technologies.

Eclevar MedTech and Meril Life Sciences, multi-centre statistical analysis in the UK
Reimbursement · United Kingdom

Meril Life Sciences.

A multi-centre reimbursement clinical trial delivered in the UK.

The Eclevar difference

Not a stats vendor. A biometry partner.

Most statistics suppliers hand back numbers. We hand back a defence your Notified Body will accept.

Generic stats vendor

Templates in, tables out. Context optional.

Boilerplate SAPA template lightly edited, with endpoints that do not fit the device.
Sample size by assumptionPower based on round-number guesses, not historical device data.
Black-box programmingDatasets you cannot trace, with no clear CDISC mapping or validation.
Analyses arrive lateInterim looks and the final analysis slip, with no DSMB rhythm.
No reviewer contextStatistics written without ever having sat on the Notified Body side.

Eclevar biometry

Your smart way to compliance, with the methods in the open.

Device-specific SAPEndpoints, hypotheses and margins built around your device and claims.
Sample size anchored to dataPower modelled on seven years of historical site data, at P25, P50 and P75.
Validated CDISC deliverySDTM and ADaM datasets and TLFs, programmed and validated under 21 CFR Part 11.
Analyses on schedulePre-specified interim looks and DSMB support, delivered to plan.
Written for the reviewerMethods and outputs shaped by leaders who reviewed files inside Notified Bodies.
The people behind the numbers

Biometry, paired with clinical and regulatory depth.

Statistics do not stand alone. Our biometry lead works beside clinicians and former reviewers who define the endpoints that matter.

Sebastien Meier Piantanida, Chief Data Officer and Head of Biometry at Eclevar MedTech
Sébastien Meier Piantanida
CDO & Head of Biometry

Thirty years in biometry and architect of the MILO EDC, leading SAPs, sample size and CDISC delivery to 21 CFR Part 11.

Professor Mark DaCosta, Chief Medical Officer and Head of Cardiovascular at Eclevar MedTech
Prof. Mark DaCosta
CMO & Head of Cardiovascular

Cardiac surgeon and former Notified Body reviewer who frames cardiovascular endpoints for Class III devices.

Pierre-Marie Boutanquoi, Chief Medical Officer and Head of Clinical Evaluation at Eclevar MedTech
Pierre-Marie Boutanquoi
CMO & Head of CER

Connects statistical results to Clinical Evaluation Reports under MEDDEV 2.7/1 Rev 4 and EU MDR.

Doctor Nikhil Khadabadi, Chief Medical Officer and Head of Orthopedics at Eclevar MedTech
Dr. Nikhil Khadabadi
CMO & Head of Orthopedics

Former senior reviewer at TÜV SÜD, defining endpoints for Class III orthopedic and spine implants.

Nancy Boodhun, Director of Operations at Eclevar MedTech
Nancy Boodhun
Director of Operations

Keeps the data clean at source through site qualification and ISO 14155:2026 oversight.

Karina, Clinical Research Associate at Eclevar MedTech
Karina
Clinical Research Associate

On-site and remote monitoring that protects data quality across European investigation sites.

Meet the full leadership team, including founder and CEO Chems Hachani

Centralised biometry

One statistical team, data from across Europe.

Biostatistics is delivered centrally from a single accountable team, working on data from EU MDR clinical investigations and PMCF studies across the core European markets. Dedicated regulatory corridors connect your device to Japan and India, and partner reach extends to 160 countries.

See operational infrastructure
France
United Kingdom
Germany
Italy
Spain
Belgium
Netherlands
Poland
Japan, PMDA
India, CDSCO
160 countries via partners
Frequently asked questions

What sponsors ask before handing over the statistics.

What should a biostatistics CRO deliver for a medical device trial?
A biostatistics CRO should deliver a device-specific Statistical Analysis Plan, a defensible sample size and power calculation, the randomization and blinding scheme, interim analysis and DSMB support, validated statistical programming, CDISC SDTM and ADaM datasets, and the statistical sections of the clinical study report. Eclevar MedTech provides all of these under EU MDR 2017/745, ISO 14155:2026 and 21 CFR Part 11.
Can you write the Statistical Analysis Plan and calculate sample size?
Yes. Our biometry team authors the Statistical Analysis Plan, defines primary and secondary endpoints and hypotheses, sets non-inferiority or equivalence margins where relevant, and calculates sample size and power, anchored to historical device data rather than assumptions.
Do you support adaptive and Bayesian designs to reduce sample size?
Yes. We design adaptive trials with sample size re-estimation and interim analyses, and apply Bayesian methods and historical borrowing where appropriate, which can reduce the number of patients needed while preserving statistical rigour.
Do you deliver CDISC SDTM and ADaM datasets and validated programming?
Yes. We produce CDISC SDTM and ADaM datasets and the tables, listings and figures for the clinical study report, with statistical programming in SAS and R under a 21 CFR Part 11 compliant, validated and reproducible workflow.
Can your statistics support PMCF studies and Clinical Evaluation Reports?
Yes. We provide the statistical methodology and analysis for post-market clinical follow-up studies and real-world evidence, and the statistical input that supports Clinical Evaluation Reports under EU MDR.
Are your analyses ready for Notified Body review?
Yes. Several of our leaders reviewed clinical files inside Notified Bodies, so our Statistical Analysis Plans, methods and outputs are written in the language and rigour reviewers expect, reducing avoidable questions during assessment.
Start with the statistics

Get a Statistical Analysis Plan and sample size from a Platinum Award team.

Send your protocol synopsis or device claims and talk methods with a senior biostatistician who has seen your device class from the other side of the review.

Talk to a biostatistician

Reforming Clinical Evaluation of Medical Devices in Europe