Class III cardiovascular and structural heart devices, run through European sites with VARC-3 endpoints, imaging core lab, independent adjudication, PMCF and CER.
Chief Operating Officer & Head of Cardiovascular
in cardiac surgery & cardiovascular device evaluation
Head of Cardiovascular Clinical Operations · DACH
ReCor
in international clinical research (cardiovascular & interventional)
Chief Data Officer · Biometrics & Data Systems
in clinical data management, EDC & biometrics systems
Senior Clinical Data Manager · Cardiovascular
in cardiovascular clinical data management
Lead Clinical Project Manager · Cardiovascular programs (France & UK)
in clinical research & medical device studies
Our clinical team on site with the manufacturers who trust Eclevar to run their cardiovascular and structural heart evidence.
Programs rarely fail because the sponsor forgot to define an endpoint. They fail because the pieces around it were built separately and only meet at database lock, where the discrepancies surface.
Most failures are interface failures, between the protocol, the sites, the reviewers, the imaging systems and the analysis datasets.
A CEC charter alone does not create reliable adjudication. Endpoint definitions, the source document package, event trigger logic, the imaging workflow, blinded review and the analysis datasets must operate as one system.
Each service is a defined deliverable. Together they carry an endpoint from the protocol to a locked, reconciled dataset.
Charter, endpoint operationalisation, governance and reviewer model.
Approved operational charterIndependent classification of pre specified clinical events.
Final adjudicated event statusCentral blinded echo assessment of valve function, PVL and gradients.
Blinded central echo readsCentral CT assessment of anatomy, sizing, access and morphology.
Device sizing inputsAlignment of site, EDC, safety and imaging data before lock.
Reconciled endpoint datasetLocked outputs, analysis-ready, for database lock and CSR.
Analysis-ready outputsRelated independent oversight, kept separate. DSMB support is a distinct safety review package for first in human and high risk studies. A DSMB is a separate body from the CEC and is never conflated with it.
We turn the endpoint framework chosen in the protocol into an operational adjudication system. Eclevar provides the governance and operations. Independence comes from the members and the governance, not from Eclevar. The endpoint taxonomy lives in the VARC-3 endpoint reference.
Operationalisation. Endpoint definitions become event triggers, source document requirements and collectable fields.
Charter and governance. Charter, reviewer selection, conflict of interest management, quorum and meeting governance.
Blinded workflow. Package assembly, reviewer assignment, independent votes, disagreement resolution and repeat adjudication rules.
The service defines which events are adjudicated and which remain reported by the site, how many reviewers are required, how disagreements resolve and how outputs reach the analysis.
It does not claim that every event needs adjudication. The plan is proportionate to endpoint importance, study phase and classification risk.
European execution
Country selection drives cardiovascular center density, device adoption, registry access, imaging readiness, follow-up reliability, contracting timelines and cost per patient.
Registry access and data governance vary by Nordic country and are assessed individually during feasibility.
For the endpoints that depend on imaging, echo, CT and angiography are assessed centrally under blinded review, then reconciled with the adjudication and analysis datasets.
Core Lab operations are managed by Eclevar and performed through qualified independent readers, integrated into Eclevar's data and adjudication workflow.
Four disciplined phases carry an event from detection to a reconciled, analysis-ready record.
The imaging and adjudication workflows stay independent. Only their outputs converge, into a single reconciled endpoint dataset.
From site echo and CT to core lab reads, DICOM pseudonymisation and endpoint adjudication, we keep a single controlled pipeline, so the same clinical event never exists in three inconsistent forms.
A recurring failure is that events are simply never sent to the CEC. Identification does not rest on the site alone.
Where these functions exist and are validated for the study, the MILO EDC platform can support the adjudication workflow, connecting event flagging, package tracking and reviewer assignment to the audit trail.
Reconciliation aligns the site reported event, the safety database, the CEC decision, the Core Lab result, the EDC endpoint field, device deficiencies and the analysis dataset into one consistent record.
The workflow is governed by SOPs and built to be ready for inspection. Frameworks such as ISO 14155, GCP principles and GDPR are applied to the scope of each study.
No certification is claimed that Eclevar does not hold. Systems are configured and validated, where applicable, to support the relevant electronic record requirements and data transfer specifications of each study.
No universal timeline is published without study specific data. The program moves through defined phases.
| Activity | Eclevar | Sponsor | Site | Reviewers |
|---|---|---|---|---|
| Charter drafting | Lead | Approves | Consulted | Consulted |
| Package QC | Lead | Oversight | Responds | |
| Adjudication | Coordinates | Blinded | Adjudicate | |
| Core Lab read | Coordinates | Oversight | Acquires | Read |
| Reconciliation | Lead | Reviews | Clarifies | |
| Final dataset | Produces | Approves |
Shared openly so sponsors can scope realistically. Scope drives the quote, so no generic prices are shown where variability is high.
Subjects, countries, duration and expected event rate
Endpoints, readers, meetings and double reading
Source documents, languages, image quality and queries
Imaging transfer, EDC integration, reconciliation and lock
Heart Team coordination, high-volume structural heart centers, proctoring logistics and monitoring, with VARC-3 endpoints and reimbursement-grade evidence built in from the protocol onwards.
Eclevar combines cardiac clinical oversight, former Notified Body review experience, data management and biostatistics in one adjudication workflow, so endpoint definitions, imaging, CEC decisions and analysis datasets stay aligned from protocol to database lock.
The biostatistics scope here covers only the adjudication and Core Lab integration. Full scope: biostatistics for medical device studies.
Related Eclevar pages across the cardiovascular and structural heart program, from clinical strategy and device evidence to core lab, PMCF and country delivery.
Receive a structured scope covering endpoints, reviewer model, imaging modalities, data workflows, timelines and cost drivers for your study.
Request a CEC & Core Lab scope assessment
