Reliable clinical data is what a submission actually rests on. Eclevar MedTech runs data management for medical device investigations only: data management plan, eCRF design, database build and validation, cleaning, coding and database lock, under ISO 14155, EU MDR, FDA guidance and ALCOA+ data integrity principles.
Chief Data Officer
Biometrics & Data Systems
in clinical data systems, biometrics and statistical reporting
Head of Quality & Compliance
ISO 14155 & data integrity
in quality systems and inspection readiness for device studies
Chief Operating Officer · former TÜV SÜD Senior Reviewer
in device evaluation and Notified Body review
Manufacturers rarely lack data. They lack data that holds up when someone reads it critically. Weak data management surfaces later as protocol deviations, a database lock that slips, monitoring costs nobody budgeted, and regulatory questions that delay market access.
Forms are configured before anyone has written down how the data will be reviewed, queried, coded and locked.
Investigators receive hundreds of low-value queries and start answering them mechanically. Data quality goes down, not up.
Central lab, imaging, ePRO and device telemetry arrive on different schedules and are reconciled at the end, if at all.
Cleaning started after the last visit. Open queries, incomplete coding and unreconciled vendor data now sit on the critical path.
Serial numbers, lot numbers, software versions, deficiencies, explantations: a general CRO treats these as free text.
Clinical operations is running the database between other responsibilities, and the documentation trail is thin.
Whether the study is a first-in-human investigation, a pivotal trial or a post-market clinical follow-up, a dedicated data management team keeps the data complete, accurate and traceable across the whole study lifecycle.
Everything that goes wrong at database lock was decided at study start-up. This is where the data management strategy earns its keep.
The controlled document defining data flow, review procedures, roles and responsibilities, query strategy, coding conventions and the lock process. How to develop an effective data management plan.
Forms built from the protocol, not from a template library: fewer entry errors, less monitoring effort, complete protocol-required data. Best practices for eCRF design.
Study complexity, budget, integrations and regulatory requirements, assessed without a software partnership behind the recommendation. How to choose an EDC system.
Visit schedules, forms, edit checks, dynamic logic, user roles, and validation testing documented before deployment. See our EDC and data management capability.
Critical data and critical processes identified with clinical operations, biostatistics and regulatory before the database is configured. What is risk-based data management.
The database is one workstream inside study start-up, next to feasibility, contracting and site activation.
A multinational device investigation does not have one data regime. Consent wording, hosting requirements, registry access and transfer rules differ by country, and they constrain the database before it is built.
Data protection rules, hosting requirements and registry access vary by country and are settled before the database is built, not after the first patient is enrolled.
From the first enrolled participant, the data is reviewed, questioned, coded and reconciled continuously. That is what makes the last month of the study uneventful.
The point of the queries. A query is not a quality metric. Ten well-aimed questions about eligibility, safety and the primary endpoint do more for the database than four hundred about formatting, and the sites keep answering them carefully.
Reviewing every variable with the same intensity was never a quality strategy. It produced query volume, site fatigue and long closeouts without improving the data that decides the study.
Risk-based data management is the counterpart of risk-based monitoring: one governs how the data is reviewed, the other how the sites are. The full method is on the risk-based data management page.
Locking a database is the result of months of continuous review. When it slips, the cause is almost never the lock itself.
Scheduled and unscheduled visits, adverse events, device deficiencies, laboratory and imaging data, device accountability, end-of-study forms.
Answered, reviewed, corrections verified, unnecessary queries closed, remaining issues escalated and documented.
Adverse events, medical history and concomitant medications coded against the approved dictionary versions, with consistency verified.
Central laboratory, imaging, ECG, ePRO, wearables and randomization systems, each reconciled against the clinical database.
Independent review of query metrics, validation records, coding and documentation before lock is recommended.
Data management, clinical operations, medical monitoring and biostatistics confirm before the database is closed. Full sequence on the database lock page.
Device identifiers, serial and lot numbers, software versions, configuration, malfunctions, deficiencies, corrective actions, implantation and explantation records. These fields carry the traceability the MDR asks for, and they are the ones most often collected as unstructured text and cleaned up at the end.
Every data management activity from protocol review to database lock, with one accountable team and one set of documentation.
A named Eclevar data manager integrated into your team, for organizations that want the expertise while keeping project oversight in house.
A defined activity: database build, database validation, data cleaning, medical coding, an interim analysis, or the database lock alone.
We work alongside sponsors, other CROs, biostatistics groups and clinical operations teams rather than requiring the whole program. Costs follow scope, study complexity and platform, quoted on the same basis as our European clinical trial cost benchmarking.
The data model is different, the traceability requirements are different, and the regulatory expectations sit under a different framework.
The data feeds the rest of the evidence chain: the clinical evaluation report, device registries under the MDR and real-world evidence programs. Teams that need the framework itself can start with our ISO 14155 training.
Published work and client evidence, not claims.
Six in-depth pages behind this one, each covering a step of the data lifecycle.
The process of collecting, validating, cleaning, coding, reviewing and preparing clinical study data for statistical analysis and regulatory submission, with a documented trail showing how every value in the final dataset got there.
During protocol development, before enrollment. Early involvement means the database design serves the analysis, the edit checks target the data that matters, and the review workflow exists before there is data to review.
Yes. We regularly work alongside sponsors, other CROs, biostatistics teams and clinical operations groups, either on the full data management scope or on a defined activity.
We are technology-independent and experienced with a range of commercial and open-source platforms. We recommend the system that fits the study rather than one we have a partnership with, and we work in your platform if you already have one.
Yes. Our data management processes are built for medical device investigations under ISO 14155, including the device accountability and deficiency data that pharmaceutical processes do not cover.
Yes. Single-country and multinational investigations, with the national data protection, hosting and consent requirements settled before the database is built.
Yes. It starts with an assessment of the current state: open queries, missing data, coding status, external data reconciliation and validation documentation. Then either remediation or a documented migration, depending on what the assessment finds.
The protocol or the current draft, the study size and country list, the platform if one is already chosen, and the target lock date. That is enough to map the data management scope and the risks.
Send us the protocol, the country list and the platform if one is already chosen. We map the data management scope, flag the risks that usually surface at database lock, and come back with a scoped plan and a named data manager.
Your documents are reviewed confidentially. An NDA can be put in place before we receive any technical or clinical information. You can also reach the team through the contact page.
Whitepaper, BSI and Eclevar
on the EU MDR
Client testimonial,
RegenLab