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Eclevar designs and delivers medical-device clinical investigations from evidence strategy and protocol development through feasibility, site execution, monitoring, data analysis and final reporting, within one accountable clinical, regulatory and operational model.
Most investigations do not fail because a visit was missed. They lose value because the design, the endpoints or the reporting were never fully connected to the decision the evidence had to support.
Former Notified Body review experience helps anticipate the questions that follow an investigation: evidence sufficiency, endpoint relevance, benefit-risk reasoning, study design and how the investigation sits within the wider clinical evidence package.
Practicing surgeons and therapeutic specialists review the population, the procedure, the endpoints and the follow-up schedule, so that what is measured is clinically meaningful and what is asked of investigators is realistic.
Clinical operations, data management, biostatistics, medical writing, safety and regulatory support work under one governance structure, with named leaders who stay involved through critical decisions and escalation.
The Clinical Investigation Report, its integration into the clinical evaluation and the questions a reviewer is likely to ask influence protocol, data and analysis decisions from the first design discussion.
Submissions to competent authorities and ethics committees are prepared and filed in-house, in France, the United Kingdom, Germany, Italy, Spain and Denmark. See selected clinical investigation programs.
A clinical investigation is one evidence route among several. It is the right one when nothing else can answer the question, and an expensive one when another source could have answered it faster.
Eclevar first tests whether another route, or a combination of routes, could meet the evidence need:
A clinical investigation should be selected because it is capable of answering the evidence question, not simply because it appears to be the expected regulatory route.
Terminology varies between jurisdictions and programs. What matters is the decision each model is capable of answering.
Investigation strategy
No model is universally superior. Each one answers a different question, carries a different design emphasis and fails in a different way.
Pathway 1
Pathway 2
Pathway 3
Pathway 4
Pathway 5
The appropriate pathway is defined by the decision the evidence must support, not by the study label alone.
Before the protocol is written, Eclevar defines the decision the investigation must support and tests whether the proposed study can generate suitable evidence.
Most of the cost is committed in the weeks after the design is agreed, when sites are contracted, systems are built and submissions are prepared. After that, changing the endpoint, the population or the comparator is expensive and sometimes impossible without restarting.
The strategy stage exists so that the expensive decisions are taken while they are still cheap to take. It produces a documented rationale for the model, the countries, the endpoints and the sequencing, the assumptions on which the budget rests, and a plain statement of what the investigation will not be able to demonstrate.
Sponsor outcome: a defensible investigation concept before significant operational budget is committed.
Protocol development is not a writing exercise. It is where the clinical pathway, the statistics and the final report are either connected or permanently disconnected.
Protocol and endpoint design
The protocol connects what is already known about the device with the evidence the program must generate. Working backwards from the intended decision clarifies the endpoint, follow-up and data requirements.
Intended purpose
Device and procedure
Existing clinical evidence
Evidence gap
Proposed claims
Benefit-risk questions
Regulatory or reimbursement decision
The protocol
Twelve design decisions, each traceable to an input and to an output.
Population and comparison
Endpoints and safety
Statistics
Safety evidence
Clinical performance
Clinical benefit
Comparative evidence
Health-economic evidence
Clinical Investigation Report and summary
CER integration
PMCF implications
Scientific communications and publications
Endpoints should be selected for the decision they must support, not because they are commonly used in the therapeutic area.
Endpoint frameworks are selected device by device and procedure by procedure. In structural heart, for example, VARC-3 definitions apply to transcatheter aortic valve replacement, while MVARC and TVARC definitions apply to transcatheter mitral and tricuspid interventions respectively. Eclevar does not represent that any regulator or Notified Body will accept a given endpoint; it documents the rationale so the choice can be defended.
The stage where the recruitment plan is either tested or assumed, before the study budget is committed to a country and site strategy.
Feasibility and site strategy
Feasibility is an assessment of evidence and delivery capacity. It is not a list of investigators who replied enthusiastically to a questionnaire.
Stage 1
Can this country deliver the evidence at all?
Stage 2
Which centers treat this population with this technology today?
Stage 3
How many eligible participants will actually be enrolled and followed?
Stage 4
Is the site operationally ready to run this protocol?
Stage 5
Three separate decisions, documented and revisited during conduct.
Selected active sites
Contracted, activated and carrying the recruitment plan.
Reserve sites
Qualified and held ready to activate if recruitment slips.
Excluded or deferred
Not selected, with the rationale documented for future re-evaluation.
Common feasibility assumptions to challenge
Site enthusiasm is not evidence of recruitment feasibility.
Sponsor outcome: a site and country strategy built on assessed delivery capacity.
Regulatory or ethics authorization alone does not activate a site. Three tracks run in parallel, and the slowest incomplete requirement sets the activation date.
Site activatedAll requirements complete against the approved site-activation criteria
Site ready for first participant enrollment
Study start-up
Regulatory or ethics authorization alone does not activate a site. Six workstreams run in parallel, and the slowest incomplete requirement determines when enrollment can begin.
Stream 1
Stream 2
Stream 3
Stream 4
Stream 5
Stream 6
Site activated
All six workstreams complete against the approved site-activation criteria
Site ready for first participant enrollment
A site is activated only when every critical regulatory, contractual, technical and operational requirement is ready.
Monitoring visits are an activity. Program management is the service: keeping recruitment, data quality, safety and site relationships within the range where the investigation can still answer its question.
Monitoring should focus on the data and processes that determine whether the investigation can answer its primary evidence question.
Intensity is adapted to device risk, design, endpoints, data criticality and site performance. Risk-based monitoring directs oversight where it changes the reliability of the result. It does not mean less oversight.
Clinical data management and biostatistics have their own service pillar, but they are not a separate delivery stream: the people designing the database work within the same program governance as the teams running the sites.
Milo Studio, Eclevar’s clinical data environment, provides a connected environment for electronic data capture, electronic clinical outcome assessment and central data review, operated by the same delivery team. It is designed to support the workflow described above. Related capability: Clinical data management.
Reporting begins during study design. The structure of the report, the analyses it will contain and the questions it must answer are defined before the first participant is enrolled, not after database lock.
A well-run investigation can still lose regulatory value if its final analysis and report do not clearly answer the original evidence question.
Sponsor outcome: a traceable, clinically interpretable evidence package aligned with its intended regulatory, reimbursement or scientific use.
Related capability: Medical Writing and Regulatory Defense.
Seven stages, one line of accountability: the objective set at stage one is what the report is measured against at stage seven.
Connected functions across all seven stages
Programs named below are published with client agreement. Status labels describe each program at the date of publication and imply no regulatory outcome.
Meril Life Sciences
Structural heart · Comparative transcatheter aortic valve program · United Kingdom
Ongoing program · Currently enrolling
Adoption and funding decisions for transcatheter aortic valve implantation increasingly require comparative clinical, imaging and health-economic evidence generated within the local health system, because such data transfer poorly between jurisdictions.
A prospective randomized multicenter clinical investigation across United Kingdom cardiac centers, comparing three contemporary transcatheter heart valve platforms, with a target enrollment of 666 participants, standardized imaging assessment, VARC-3 endpoint definitions and health-economic data collection.
Randomization across three device platforms in interventional cardiology centers, with standardized imaging at every visit, independent endpoint adjudication and health-economic capture running alongside routine clinical workflow.
A comparative clinical, safety, imaging and health-economic dataset intended to support reimbursement and market-access discussion in the United Kingdom, and to feed the sponsor’s clinical evaluation and post-market documentation.
One organization accountable for the comparative design, the regulatory route, the participating centers, the imaging and adjudication chain and the final analysis, so that the evidence matches the access decision it was commissioned to inform.
The program is in progress and currently enrolling. No comparative result, clinical superiority, conformity assessment outcome or reimbursement decision is claimed or implied. Third-party manufacturer names, where used, identify the device platforms under evaluation and do not indicate any endorsement or association.
JRI Orthopaedics
Orthopedics · Ceramic hip resurfacing system · Pre-market clinical investigation
Two-part investigation · In progress
An innovative resurfacing implant has to demonstrate early safety and performance quickly enough to support development decisions, while committing to the long-term follow-up that joint replacement evidence requires.
A two-part architecture. Part one addresses early safety and performance. Part two addresses long-term clinical performance and implant survivorship, with a registry-informed external comparator strategy and longitudinal radiographic follow-up.
Two linked evidence streams with different time horizons, imaging that must stay comparable over years rather than months, electronically collected patient-reported outcomes, and an external comparator strategy defined before the first analysis.
An integrated evidence program covering imaging follow-up, patient-reported outcomes and function, safety and revision events, and long-term survivorship, designed to support clinical evaluation and post-market clinical follow-up.
An evidence architecture designed once, for both the near-term development decision and the long-term performance question, rather than a short study followed by an attempt to reconstruct comparability years later.
Scope: this is an ongoing pre-market clinical investigation of a device developed and owned by JRI Orthopaedics. Eclevar contributed to the evidence architecture, the follow-up plan and the statistical methodology. Eclevar did not sponsor the investigation, did not recruit participants and did not conduct all operational activities. Assessments described here were designed, not performed by Eclevar. No clinical result, non-inferiority conclusion or regulatory decision is claimed. Participating institutions and cohort sizes are not disclosed.
Coloplast A/S
Continence care · Compact intermittent catheter · Three European countries
Pre-market clinical investigation · Completed
A randomized, open-label crossover investigation in adult female intermittent catheter users.
Evaluate a non-CE-marked investigational catheter against marketed comparators on an objective bladder-emptying endpoint that depends on catheterization technique, on whether the catheterization is performed by a nurse or by the participant, and on four weeks of unsupervised use at home.
A multicenter, randomized, open-label crossover investigation with 72 planned participants across three European countries, four site visits per participant and two home-use test periods of two weeks each, with one marketed comparator allocated per participant by randomization and an identical assessment schedule in both periods.
Evidence across four domains, bladder-emptying performance, safety and device deficiencies, catheter perception and handling, and home-use experience, supporting EU MDR clinical evaluation and pre-market conformity assessment.
A crossover design executed identically in three jurisdictions, with the objective endpoint measured consistently whether the catheterization is performed by a professional or by the participant at home.
Pre-market clinical investigation. The devices are developed and owned by Coloplast A/S. Design, registration and scale details are taken from the public clinical trial registration and the registered clinical investigation plan. Assessments are described as designed, not as completed, and the planned participant number is the number stated in the registered plan. Eclevar contributed to clinical evidence architecture, European delivery and statistical methodology, and did not develop, manufacture or own the devices. No clinical outcome, comparative claim, superiority conclusion, performance claim or regulatory decision is stated or implied, and no endorsement of Eclevar by Coloplast is implied. Manufacturer names and trademarks are used solely to identify the sponsor of the investigation. Participating institutions and investigators are withheld. See further client programs.
Eclevar does not claim equal depth in every specialty. The areas below are where clinical leadership, delivery experience and site relationships are strongest.
Pillar page in preparation. Discuss a SaMD evidence program.
Named leaders across the United Kingdom, France, the DACH region and the United States stay involved from strategy through site delivery, analysis and reporting.
Chief Operating Officer and Head of Cardiovascular
Mark leads Eclevar’s cardiovascular clinical and regulatory strategy, combining 25 years of Consultant Cardiac Surgery experience with first-hand senior Notified Body leadership experience as a former TÜV SÜD Team Leader and Senior Clinical Reviewer.
Chief Medical Officer, Orthopedics and Spine
A practicing NHS orthopedic surgeon and former TÜV SÜD Senior Reviewer, Nikhil leads investigation design for Class III implantables across orthopedics, spine and surgical robotics, where survivorship, imaging and learning-curve considerations determine the study design.
Head of Clinical Operations, DACH Region
Susanne leads clinical operations in the DACH region, covering site identification and qualification, activation, monitoring oversight and investigator relationships in German-speaking centers.
Strategic Clinical Advisor, United States
Provides strategic input on U.S. medical-device clinical operations, regulatory considerations and real-world evidence programs.
Head of Medical Writing
Pierre-Marie owns the written evidence chain: protocols, the Clinical Investigation Report and summary, integration into the clinical evaluation, PMCF documentation and structured responses to reviewer and authority questions.
Chief Data Officer
Sébastien owns data strategy, EDC and eCOA architecture, data management standards, biometrics and the production of analysis-ready datasets, so that the analysis planned at design stage is the analysis that can actually be run.
Program delivery accountability
Charline Petitdemange Project Lead Program mobilization and cross-functional deliveryFormer positions are stated for biographical context only. Eclevar MedTech is independent and is not affiliated with or endorsed by TÜV SÜD. Notified Body review experience is a professional background, not a medical qualification, and the two are stated separately above. See the full executive team.
A precise full-service proposal depends on a defined study concept. Where the concept and its assumptions are not yet settled, the workshop is the fastest way to reach one.
A written summary of the recommended investigation model and the reasoning behind it, the countries and site strategy, the endpoint and follow-up architecture, the assumptions the budget will rest on, and the delivery risks that need a decision before a proposal is issued.
Where the assessment indicates that a registry, a retrospective study or an appraisal of existing data would answer the question more efficiently, that is what the summary will say.
The EU MDR requires clinical investigations where the available clinical data are not sufficient to demonstrate conformity with the relevant general safety and performance requirements. In practice this usually applies to implantable and class III devices under Article 61(4), and to any device where equivalence cannot be adequately demonstrated, where the technology or intended purpose is novel, or where the existing data do not represent the intended population or conditions of use. The decision is specific to the device, the claims and the existing evidence, and is taken together with the clinical evaluation plan.
A clinical investigation generates clinical data for a device that is under investigation, most often before conformity assessment or before an extension of the intended purpose. A post-market clinical follow-up study generates data for a device already placed on the market under its CE-marked intended purpose, in order to confirm safety and performance, address residual risks and answer questions raised in the clinical evaluation. A PMCF activity can itself take the form of a clinical investigation, so what decides the requirements is the regulatory pathway and the evidence question, not the label.
Yes. Eclevar delivers complete clinical investigations: strategy, protocol and statistical design, site contracting and activation, monitoring, data management, biometrics, safety oversight and final reporting. Regulatory and ethics submissions are prepared and filed in-house rather than subcontracted, in France, the United Kingdom, Germany, Italy, Spain and Denmark.
Country selection follows the regulatory pathway, the clinical pathway and standard of care, comparator availability, reimbursement context and realistic recruitment capacity. Site selection follows documented feasibility: eligible patient flow, competing studies, investigator and device experience, research infrastructure, imaging and laboratory capability, data entry capacity and submission readiness. Sites are recommended on assessed delivery capacity, with a reserve site strategy defined at the same time.
As a minimum: the device and its development stage, the intended purpose and target population, the existing evidence and the identified gap, the decision the evidence must support, the proposed claims, the comparator, the candidate endpoints and follow-up duration, the countries under consideration and any imaging or central assessment requirements. Where these are not yet defined, a scoping workshop reaches a reliable proposal faster than an exchange of assumptions.
Start-up duration depends on the countries selected, the regulatory route, the completeness of the technical and clinical documentation, contracting complexity and site readiness, so a single figure would be misleading. Eclevar builds the start-up plan country by country and site by site, states the assumptions behind each milestone, and tracks activation against documented readiness criteria, not contract signature.
The principal cost drivers are the number of participants, sites and countries with their regulatory routes, follow-up duration and visit burden, the monitoring model and source data verification intensity, imaging and central assessment, endpoint adjudication, the comparator, device logistics and the scope of statistical and medical writing deliverables. Design decisions taken early, particularly on endpoints and follow-up, usually influence cost more than unit rates.
A monitoring strategy defining central, remote and on-site activity, source data review and verification proportionate to data criticality, informed consent review, protocol compliance oversight, safety and device deficiency review, recruitment and retention tracking, data quality indicators, investigator engagement, issue escalation and corrective actions, essential document and trial master file oversight, and close-out readiness.
Yes. A transfer begins with an assessment of the protocol and its evidence question, recruitment performance, data quality and outstanding queries, safety and device deficiency handling, essential documents and trial master file completeness, and site relationships. Eclevar then proposes a remediation plan stating what can realistically be recovered, what requires a protocol or statistical amendment, and what will remain a documented limitation of the dataset.
The report presents the investigation as conducted rather than as planned: objectives and design, participant disposition and baseline characteristics, exposure, endpoint results, safety and device deficiency summaries, protocol deviations, subgroup and sensitivity analyses, imaging and adjudication outputs where applicable, clinical interpretation, limitations and conclusions, with the statistical outputs and appendices. It is written to be read alongside the clinical evaluation report and the post-market documentation.
Yes, provided the requirement is identified during design. Resource use, procedure and length-of-stay data, quality-of-life instruments and other health-economic measures have to be built into the schedule of assessments, the case report form and the statistical analysis plan from the beginning. Adding them after database lock is rarely possible, so market access requirements belong in the strategy discussion.
Investigation results are appraised alongside literature and other clinical data in the clinical evaluation, contribute to the benefit-risk determination for the intended purpose, and inform the post-market clinical follow-up plan by identifying the residual questions that follow-up must answer. Designing for that integration keeps endpoints, definitions and populations consistent across the clinical evaluation report, the PMCF plan and any subsequent study.
Each stage of the pathway, and the investigation models that use it.
Share the device, development stage, target population, existing evidence and intended regulatory or commercial decision. Eclevar will help determine the appropriate investigation model, countries, sites, endpoints, timeline and principal delivery risks.
