Electronic Clinical Outcome Assessment is where patient data quality, GDPR compliance and ethics approval are won or lost. Eclevar designs, validates and runs eCOA, ePRO, ClinRO and ObsRO for medical device investigations under ISO 14155, with in-house teams that navigate ANSM, CPP, BfArM, PEI and the Ethik-Kommission.
In-house teams · 7 countries
One accountable team runs your instrument selection, French and German linguistic validation and data capture, on the MILO Studio platform that won the Platinum Award at the xShare & EUCROF 2026 Open Call.
Horizon Europe · Grant Agreement No. 101136734 · Amsterdam, 2 Feb 2026
Device leaders across cardiovascular, orthopedics, wound care and more choose Eclevar. Read all client success stories.
eCOA, electronic Clinical Outcome Assessment, is the electronic capture of clinical outcome data in a trial, giving accurate, time-stamped, patient-driven evidence that improves compliance and endpoint quality over paper.
eCOA is the umbrella for three instrument types: ePRO (patient-reported outcomes, completed by the patient), ClinRO (clinician-reported outcomes) and ObsRO (observer-reported outcomes, completed by a caregiver or non-clinical observer). For medical devices, eCOA is governed by ISO 14155 and EU MDR 2017/745, not the pharma ICH-GCP framework, and every instrument must be validated and mapped to the study endpoints and the General Safety and Performance Requirements. Capture runs through validated apps and devices that feed the clinical EDC.
Across France and Germany, eCOA best practice is not just a matter of choosing a platform. It combines instrument selection and validation, French and German linguistic validation, GDPR and DPIA-grade data protection and the right ethics and competent authority route for the study type. Germany applies one of the strictest readings of the GDPR, and the Ethik-Kommissionen and French CPPs do not accept English-only documents. Done well, eCOA is the difference between a trial master file that survives a Notified Body inspection and one that unravels under it.
Eclevar delivers eCOA as one connected service across the clinical investigation lifecycle, feeding the clinical evaluation report and the post-market clinical follow-up that keep a CE certificate valid.
Eclevar's model brings the regulatory perspective inside the CRO, eliminating the gap between what manufacturers submit and what assessors expect. Dr Mark Da Costa, COO and former TÜV SÜD reviewer, and Dr Nikhil Khadabadi, CMO for orthopedics and spine and also a former TÜV SÜD senior reviewer, lead a team that designs clinical evidence exactly the way Notified Bodies expect to read it, from the first protocol version.
Who builds and validates your eCOA, and how, decides whether your patient data survives inspection in France and Germany. The gap between a generic eCOA vendor and a device-native CRO team is structural.
From instrument selection to database lock, every eCOA activity is run to ISO 14155 and captured with full traceability for Notified Body inspection across France and Germany.
Choosing the right ePRO, ClinRO and ObsRO measures, mapped to your endpoints and GSPRs, aligned early through our feasibility and site selection.
Validated French and German translations of the app, questionnaires and ICF, with linguistic validation certificates so migrated instruments stay equivalent to the original measure.
EU-based hosting on ISO 27001 or TÜV-certified infrastructure, DPIA and DPA, vendor security validation and clear electronic-data disclosure in the ICF, for Germany's strict GDPR reading.
The right route by study type: BfArM/PEI plus Ethik-Kommission for interventional, ethics plus BfArM notification for NIS/AWB, and ANSM plus CPP in France, aligned to our EU MDR regulatory strategy.
Paper-to-electronic migration and eCOA configuration on MILO Studio, with equivalence testing so electronic and reference versions read the same.
Ongoing clinical monitoring, real-time centralised review and clean database lock, backed by our ISO 13485 quality system.
One accountable team covers every stage of the clinical investigation lifecycle, so nothing is lost between an eCOA instrument, an ethics submission and a Notified Body file.
Pre and post-market trials under ISO 14155, from feasibility and site selection and study initiation through multi-country ethics submissions and on-site and remote monitoring.
The clinical evaluation report under MDCG 2020-6, PMCF Plans and SSCP, written by clinicians and reviewed by former Notified Body assessors.
100% in-house clinical data management and EDC: eCOA and eCRF design, DMP and DVP, powered by MILO Studio, natively built for EU MDR.
Structured post-market clinical follow-up meeting MDCG 2020-7 Level 4 criteria, with validated ePRO questionnaires and MILO Studio capture.
National registry integration (NJR, EUDAMED) for long-term real world evidence and PMCF follow-up of implantable devices.
Regulatory affairs and clinical strategy for CE mark pathways and equivalence, backed by a quality management system certified to ISO 13485.
A manufacturer running a device investigation across French and German sites faced rejected ethics dossiers and GDPR queries after an off-the-shelf eCOA vendor supplied English-only questionnaires and unclear data hosting. Eclevar rebuilt the approach: instruments were selected and validated against the endpoints, French and German linguistic validation certificates were produced, and the eCOA was configured on MILO Studio with EU hosting on ISO 27001 infrastructure.
A DPIA, DPA and clear electronic-data disclosure in the ICF cleared Germany's strict GDPR reading, while the study was classified correctly so the BfArM notification, Ethik-Kommission and French ANSM and CPP routes matched the study type. When the Notified Body reviewed the file, the eCOA evidence trail was complete and defensible, and it directly supported the clinical evaluation report and ongoing PMCF.
Outcome: ethics approvals granted in both countries, GDPR queries closed and an inspection-ready patient-data trail, instead of a stalled multi-country start-up.
Former Notified Body reviewers from TÜV SÜD. We know what fails inspection and design programs to avoid it.
Clinical ops, writing and data management. One point of accountability, no handoff fragmentation.
Proprietary EDC built natively for EU MDR, with eCOA, Annex XIV mapping and AI eCRF generation.
Paris, London, Tokyo and Pune. In-house teams in seven countries, not a network of subcontractors.
Platinum Award winner, EUCROF 2026, ranked first for clinical innovation and data strategy.
ISO 13485 certified. Every program structured for TMF completeness and Notified Body inspection readiness.
A network of employed clinical and data specialists, not subcontractors, gives sponsors consistent quality and one accountable team across the EU, the UK and Japan corridors.
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, relevant to any high risk device program.
Eclevar manages RegenLab's PMCF program 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 that supports both Notified Body scrutiny and reimbursement endpoints, from protocol design through to final study report.
« Eclevar, with its tailor-made approach and advanced Milo Studio platform, represents a major strategic asset. »
eCOA, electronic Clinical Outcome Assessment, is the electronic capture of clinical outcome data in a trial. It groups ePRO (patient-reported outcomes), ClinRO (clinician-reported outcomes) and ObsRO (observer-reported outcomes) collected on validated devices or apps. In medical device investigations under ISO 14155 and EU MDR 2017/745, eCOA gives accurate, time-stamped, patient-driven data that improves compliance and endpoint quality over paper.
eCOA is the umbrella term for all electronically captured clinical outcome assessments. ePRO is completed by the patient, ClinRO by the investigator or clinician, and ObsRO by a non-clinical observer such as a caregiver. A single device trial often combines all three, each validated and mapped to the study endpoints and the General Safety and Performance Requirements.
Germany applies one of the strictest readings of the GDPR. eCOA data should be hosted in the EU, ideally in Germany, on ISO 27001 or TÜV-certified infrastructure. A Data Protection Impact Assessment (DPIA) and a Data Processing Agreement (DPA) are expected, the eCOA vendor must supply security validation evidence, and electronic data processing must be clearly disclosed in the Informed Consent Form.
Ethics committees in Germany and France do not accept English-only documents. The eCOA app, questionnaires and Informed Consent Form must be provided in German for German sites and in French for French sites. Translated outcome instruments must be supported by linguistic validation certificates so the migrated ePRO is proven equivalent to the original validated measure.
It depends on the study type. Interventional clinical investigations need dual approval from BfArM or PEI plus the Ethik-Kommission. Non-interventional studies (NIS/AWB), which is where most eCOA-based RWE and PMCF projects sit, need Ethics Committee approval plus notification to BfArM. Classifying the study correctly up front decides the whole submission route.
Eclevar selects and validates the eCOA instruments, builds ePRO, ClinRO and ObsRO on MILO Studio, and handles French and German linguistic validation, GDPR and DPIA documentation and ethics and competent authority submissions to ANSM, CPP, BfArM, PEI and the Ethik-Kommission. Delivery is fully in-house across seven countries, structured for Notified Body inspection readiness.
eCOA for devices must handle operator-dependent variables, migration equivalence, multi-country language validation and endpoints mapped to the General Safety and Performance Requirements, all under ISO 14155 rather than ICH-GCP. A specialist medical device CRO with former Notified Body reviewers designs the eCOA and its evidence trail the way assessors, ANSM and BfArM expect to read them.
Talk to our specialists about your device trial, your French and German sites and an eCOA plan built to ISO 14155 and GDPR from day one.
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