Home / Feasibility and Site Selection
Feasibility decides where a clinical investigation will actually recruit, and it decides it before the protocol is locked and the first site agreement is signed. Eclevar builds that answer country by country and site by site, for the device and indication you are taking through EU MDR and, where relevant, the Great Britain clinical investigation requirements under the UK MDR 2002.
From country landscape to enrollment forecast
Feasibility produced by people who will not be there during enrollment tends toward optimism. At Eclevar the same clinical operations, data management and regulatory functions that carry a study through start-up, monitoring and reporting produce the feasibility answer first.
Eclevar's operating scope varied between these programs, from full clinical operations delivery to defined workstreams. The figures describe programs supported. They do not describe recruitment, regulatory or commercial outcomes.
Device manufacturers across cardiovascular, orthopedic, wound care and dental portfolios. Read the client success stories.
Not whether the study is a good idea. Whether the study as drafted can be executed in the countries and sites available to you, at the pace the program plan assumes.
A feasibility report earns its cost only if it is capable of telling you not to run the study as designed.
Feasibility connects directly to the workstreams that follow it: study start-up, monitoring, clinical data management and regulatory strategy. The assumptions written at feasibility are the ones start-up is held to.
A short working document capturing device, indication, target markets, endpoints, recruitment goals and the questions the assessment has to answer. Assumptions are recorded here so the later forecast can be traced back to them.
Standard of care, patient pathways, reimbursement context, the applicable national submission route and competing device studies, taken country by country rather than as a European average.
Candidate sites and investigators, procedure volumes, prior device investigation experience, and direct input from clinicians on whether the protocol is workable in their unit and their operating room schedule.
A prioritized list split into Wave 1 and Wave 2, with the rationale for each recommendation written beside it and the sites that were considered and set aside recorded as well. Wave 2 exists so that a site that does not deliver is replaced from a list that was already assessed, not from whoever is available that month.
A model with projected monthly enrollment, start-up sequencing and the risk flags that would change it, presented in a working session with your clinical, regulatory and program teams.
The sequence is fixed. The elapsed time is not: it depends on the device, the number of countries, the size of the site list and how quickly investigators respond. A schedule is agreed at scoping and revised in writing if the scope changes.
Reviewers ask how the countries, the sites and the participant population were chosen, and whether the population is representative of the intended purpose. The feasibility report is written so that question has a documented answer rather than a reconstructed one.
Chief Operating Officer and Head of Cardiovascular, Senior Consultant Surgeon
Mark leads cardiovascular clinical strategy, combining 25 years of Consultant Cardiac Surgery experience with first-hand senior leadership Notified Body experience.
On feasibility work he tests the country and site recommendation against the intended claims, the endpoints and the participant population the clinical evaluation will have to support.
Project Delivery Lead, France and United Kingdom
Charline coordinates French and United Kingdom clinical programs from mobilization through close-out, across sponsor teams, clinical operations, data management, medical writing and external vendors.
Delivery is where a feasibility assumption is confirmed or exposed, which is why delivery reads the assessment before it is issued.
Head of Medical Writing
Pierre-Marie leads medical writing, with more than ten years on EU MDR clinical evidence programs: Clinical Evaluation Reports, PMCF documentation, clinical investigation reports and responses to reviewer deficiencies.
The site selection rationale has to survive into that documentation, which is why it is written during feasibility rather than reconstructed afterward.
Regional clinical operations leadership is named on the leadership page: Susanne Höfer for the DACH region, Scott Roe for the United Kingdom, Teresa Cosentino for Italy. The final engagement team and individual responsibilities are confirmed for each program according to the device, therapeutic area, countries, study design and contracted scope.
Former positions are stated for biographical context only. Eclevar MedTech is independent and is not affiliated with or endorsed by any notified body. Meet the full leadership team.
Post-market clinical follow-up evidence was required for chronic wound devices across two distinct indications, diabetic foot ulcer and venous leg ulcer, each with its own referral pathway, treating specialty and follow-up rhythm.
A randomized post-market program of 160 participants across 14 sites in five European Union countries, with the two indications recruited in parallel.
Eclevar designed and is managing the program, from protocol design through clinical operations and data management to the Clinical Investigation Report, using the Milo Studio environment for data capture.
Two indications treated in different units meant the site list could not be built once. Site selection had to hold for both pathways, which is a feasibility question before it is an operational one.
Program status is ongoing. Evidence is intended to support EU MDR clinical evaluation and post-market clinical follow-up activities. No result, regulatory outcome or reimbursement outcome is claimed. Published with the sponsor's permission. Antoine Turzi, Chief Executive Officer of RegenLab, has described Eclevar's tailor-made approach and the Milo Studio platform as a major strategic asset.
A growing manufacturer did not know which European countries and sites could recruit within the budget available for a first European investigation. The feasibility work returned a three-country recommendation with participant volumes, the assumptions behind them, and a second-wave list held in reserve.
An established manufacturer needed post-market clinical follow-up data under EU MDR for a Class III implant whose routine follow-up was inconsistent between sites. The site list was built around documented follow-up capacity rather than implant volume alone, and the data flow into the clinical evaluation was defined at the same time.
A United States manufacturer entered Europe with limited visibility of national health systems. The assessment compared candidate countries on ethics and competent authority routes, standard of care differences and reimbursement context, so the footprint was chosen with the constraints visible rather than discovered later.
These three descriptions are anonymized and cover the feasibility work Eclevar performed. No recruitment, regulatory or commercial outcome is claimed for any of them.
European feasibility is delivered by Eclevar's own clinical operations teams. Work outside Europe runs through established partnerships, and the delivery model is confirmed for each program before anything is quoted.
Requirements for a clinical investigation vary by country and by device. There is no single uniform European authorization, so the country recommendation is always made against the specific submission route the device is taking.
It is the assessment of whether a clinical investigation or post-market clinical follow-up study can be executed as designed, carried out before budget is committed. It covers the participant population available in routine practice, the capability and capacity of candidate sites, competing studies in the same population, and the alignment between the country strategy and the regulatory route the device is taking. The output is a written recommendation with an enrollment forecast and the assumptions behind it.
Higher-risk devices from Class IIa to Class III, with dedicated teams in cardiology and structural heart, orthopedics and spine, neuromodulation and neuro-implants, advanced wound care and dental devices. Therapeutic fit matters more than device class in feasibility work, because the participant pathway, not the classification, determines whether a site can recruit.
The five stages always run in the same order, but the elapsed time depends on the number of countries, the size of the site list, the complexity of the indication and how quickly investigators respond. A schedule is agreed at the scoping stage against your program milestones and is revised in writing if the scope changes. Eclevar does not quote a fixed duration before the scope is known.
Either. Milo provides a connected environment for feasibility and study data, and Eclevar is platform agnostic: if you already run a validated electronic data capture system, the program can be delivered in it. The choice is made on the study, the sponsor's existing validation status and the data that has to move between feasibility and study conduct. See clinical data management.
Yes, through established partnerships in Japan, India, Brazil and Colombia. The delivery model differs from European work, where Eclevar operates with its own clinical operations teams, so the arrangement for each territory is confirmed before the scope is agreed.
Under MDR Article 61 and Annex XIV, clinical evaluation must be planned against the device characteristics, the intended purpose and the relevant target population. Feasibility helps document why the selected countries and sites are suitable for generating evidence relevant to that population. The regulation defines the evidence context; the feasibility work builds and records a country and site strategy that can be defended within it. See clinical evaluation reports.
You get that answer in writing, with the reasons and the options. In practice the outcome is usually a change to the design rather than an abandonment: a different country set, a wider eligibility window, a longer recruitment period, or a different evidence model such as a post-market clinical follow-up study. An assessment that can only confirm the original plan is not worth commissioning.
Send the device, the indication, the endpoints under consideration and the markets you are targeting. Eclevar comes back with the questions the assessment would have to answer, the countries worth including in scope, and what the work would involve.
