Clinical Data Management · EU MDR · ISO 14155

Data that survives
any inspection.

We design and operate the clinical data management infrastructure behind EU MDR PMCF programs ‒ from Data Management Plan authoring to database lock, with every field traceable to an Annex XIV requirement from Day 1.

Explore Capabilities

Data Management Metrics.

87%

of PMCF EDC build-ups reviewed contained at least one field with no traceable link to a CER residual risk.

43%

of EDC platforms in use were not fully validated against 21 CFR Part 11 or ISO 14155:2020.

15yr

minimum clinical data retention required for implantable devices ‒ the archive format must endure.

34 PMCF programs reviewed in 2025. Eclevar Medtech Internal Audit - Class IIb / III Devices.

Our Approach

We do not outsource data management.

Our in-house team enables seamless communication with the clinical study team, reduces database builds by 50%, and facilitates industry-leading Site Initiation Visit (SIV) timelines. Our MILO platform drives a seamless, error-proof study data integration from day one in our client assignments.

Electronic Case Report Form (eCRF) design.

Thorough manual and pragmatic review of clinical data.

eConsent and comprehensive Data Capture Plans.

Adverse event and medication coding.

EDC selection, build, validation, and training.

Database lock and Secure Data Transfer protocols.

Our Services

Six data management capabilities ‒
one integrated framework

Each capability maps to a distinct phase of your PMCF study data lifecycle and a specific regulatory obligation under EU MDR, ISO 14155:2020, and 21 CFR Part 11.

Data Management Plan Authoring

Full Data Management Plan covering all eight mandatory domains: data sources, dictionary, access controls, edit check specifications, query management, database lock, archiving, and GDPR compliance.

ISO 14155 21 CFR Part 11 GDPR

EDC Architecture & Validation

Field-level EDC specifications with Annex XIV dual-mapping. Platform-agnostic approach supporting MILO, but also Medidata, Veeva, OpenClinica or other systems favored by our clients.

MILO EDC IQ/OQ/PQ UAT

Query Management & Monitoring

End-to-end query lifecycle management with Data Review Committee (DRC) facilitation, performance metric reporting, and Site Action Plans for threshold breaches.

DRC Operations KPI Tracking

Database Lock & Statistical Transfer

Five-step lock protocol including completeness audit, blind data review, coding completion, multi-party e-signature, and SHA-256 checksum export with a documented chain-of-custody.

Lock Protocol MedDRA Coding

EDC Remediation & CAPA Programs

Tailored for manufacturers with non-validated or ANSM/FDA-cited EDC systems. Root cause analysis, CAPA documentation, accelerated platform migration, and Notified Body pre-audit management.

CAPA ANSM Remediation

Inspection Readiness Assessment

Pre-Notified Body, pre-FDA, and pre-EMA data audit covering 144 TMF items. Comprehensive gap report with a remediation roadmap delivered within 5 business days.

FDA BIMO EMA GCP Notified Body Prep

Data Management Lead

The specialist responsible
for your data program

At Eclevar Medtech, data management is led by a dedicated Chief Data Officer - one person accountable for your Data Management Plan, your EDC, and your inspection readiness.

Chief Data Officer - Eclevar Medtech

Sébastien Meier Piantanida

Sébastien oversees EDC platform architecture, Data Management Plan authoring, biostatistical analysis, and all technical specifications for the data management framework. He leads UAT design, edit check specifications, and database lock operations across the full client portfolio.

EDC Architecture 21 CFR Part 11 ISO 14155:2020 Database Lock ANSM Remediation

Contact Sébastien

Questions and Answers

Common questions from regulatory and clinical operations teams about clinical data management under EU MDR.

If your question is not answered here, please write to clientcare@eclevar.com or any of our team members. We respond within One Business Day.

What exactly is a Data Management Plan and is it mandatory under EU MDR?

A Data Management Plan is the master document governing every biometric data handling decision. Under ISO 14155:2020 Clause 9.5, sponsors must establish and maintain data management procedures ensuring integrity. Notified Bodies now routinely request the Data Management Plan as a standard PMCF submission artifact.

Our EDC was chosen by IT without regulatory input. Is this a problem?

Almost certainly, yes. If your current platform lacks IQ/OQ/PQ validation against a formal Validation Master Plan, an immutable audit trail, and 21 CFR Part 11 electronic signatures, you are running a non-validated electronic records system. This is citable in any FDA, EMA, or Notified Body data audit.

We are six months from a Notified Body audit. Can gaps be remediated in time?

Yes. We deliver a written gap analysis with a prioritised remediation roadmap within five business days. We have completed EDC remediation programs and delivered inspection-ready data packages on nine-month timelines for Class III AIMD programs.

What is the difference between 21 CFR Part 11 and ISO 14155:2020 data management?

21 CFR Part 11 establishes specific technical requirements, such as audit trails and electronic signatures. ISO 14155:2020 is the international GCP standard requiring the same functional outcomes but expressed as performance requirements. The Eclevar Medtech framework is designed to deliver both.

Guaranteed Response Within One Business Day

Your data program should be
inspection-ready from Day 1.

Download the complete Clinical Data Management whitepaper or book a free 30-minute PMCF Data Audit. A contractual written gap analysis will be delivered within five business days.

Data that survivesany inspection.