Most cost overruns in medical device trials are not budget surprises. They are preventable costs decided on rules of thumb before real costing. Eclevar forecasts cost, sites and recruitment up front, itemising site grants, CRO effort and pass-through costs so your EU MDR budget is defensible before it becomes a binding commitment.
Benchmarked · 7 years of data
Country-specific site tariffs, CRO effort priced per role and hour, and full pass-through costs, benchmarked on the delivery data behind the MILO 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, orthopaedics, wound care and more choose Eclevar. Read all client success stories.
Clinical trial cost forecasting is the disciplined estimation of what a medical device investigation will really cost, and how long it will take to recruit, produced before the design is locked and the budget is approved.
A real forecast is more than a CRO quote. It brings together three drivers that most quotes surface too late: country-specific site grants, CRO effort priced per role and hour, and the pass-through costs such as ethics and IRB fees, courier, customs and device kit shipment. It anchors the recruitment timeline to historical site performance rather than investigator optimism, then expresses the result as a range, not a single reassuring number.
This matters because of a regulatory trap. Under EU MDR Article 62 and Article 74, a PMCF or clinical investigation plan submitted to a Notified Body becomes a binding financial and operational commitment. If the true cost only appears after CE marking, redesign is expensive and often impossible, and the overrun is absorbed or a second indication is sacrificed.
Eclevar forecasts cost the way it delivers trials, as one connected service across the clinical investigation lifecycle, so the budget you approve before feasibility is the budget your data and monitoring plan can actually deliver.
A number is only as good as the protocol it prices. Eclevar's model puts the regulatory perspective inside the forecast: Dr Mark DaCosta, COO and former TÜV SÜD reviewer, pressure-tests methodology defensibility, endpoint hierarchy, sample size justification and amendment risk, so the design you cost is one a Notified Body will accept, and the sites and recruitment behind it are realistic. That closes the gap between a hopeful budget and a defensible one, from the first protocol version.
The number you approve before feasibility decides whether the trial is affordable, or whether the overrun surfaces once the design is already a regulatory commitment. The gap between an opaque quote and an integrated forecast is structural.
A defensible forecast breaks the budget into the drivers that move it most, then models each one against benchmarked data rather than a single blended rate.
Per-patient and per-site tariffs vary widely across France, Germany, the UK, Italy, Spain and Eastern Europe, tied directly to your feasibility and site selection.
Project management, monitoring, clinical trial administration, biostatistics and medical writing, each priced per role and hour rather than hidden in a blended total.
Ethics and IRB fees, courier, customs and device kit shipment, fully itemised so they never appear as a mid-execution surprise.
The single largest source of overrun. Modelled as P10/P50/P90 against historical site start-up and enrolment data, not PI estimates.
eCRF build, data management and monitoring effort scale with duration and site count, so a longer trial silently costs more on every line.
Endpoint hierarchy, HTA dossier and payer work set the scope, mapped early through EU MDR strategy before the design is locked.
One accountable team parses your plan and returns parallel cost, site and recruitment forecasts, each in three scenarios, so budgeting, feasibility and regulatory review are all built on the same numbers.
We parse your PMCF plan or synopsis and return three linked forecasts, so a change to sites or feasibility reflows the budget and timeline together.
Every forecast in three scenarios: a lean registry-led Swift design, a realistic full-scope Base, and a Conservative worst-case envelope with intensive monitoring and full HTA.
P10/P50/P90 enrolment ranges anchored to historical site performance, so the timeline reflects reality, not a single optimistic assumption.
CRO line items priced per role and hour, country-specific site tariffs and full pass-through breakdown, backed by our ISO 13485 quality system.
A former Notified Body reviewer checks methodology, endpoint hierarchy and amendment risk so the clinical evidence the budget buys will hold up.
Costed options for equivalence, registry-based real world evidence and CE pathways, mapped through EU MDR strategy.
The post-CE commitment trap. A cardiovascular sponsor locked its PMCF plan as a regulatory commitment before any real cost modelling, with the envelope set on rules of thumb. The first CRO quote excluded site fees, and the final cost ran to several times the original budget. Because the plan was already binding, redesign was impossible: the overrun was absorbed and a second indication launch was sacrificed.
The recruitment forecast trap. A wound care sponsor's protocol assumed 24-month enrolment across 12 sites; investigators estimated 28 months. A conservative, data-anchored forecast would have flagged 84 to 108 months. Recruitment slipped badly, a competitor captured the market window, and the trial published too late to be commercially viable. A realistic feasibility forecast would have surfaced that risk before the design was fixed.
The lesson: both costs were preventable. Forecasting cost, sites and recruitment before the first feasibility round keeps the design free to change while it still can.
Former Notified Body reviewers from TÜV SÜD. We cost the design a Notified Body will actually accept, so the budget is not built on a protocol that fails.
Clinical ops, writing and data management under one roof. The team that quotes the trial is the team that runs it.
Country-specific site tariffs and CRO rates drawn from seven years of European delivery data, not generic assumptions.
Paris, London, Tokyo and Pune. In-house CRAs in seven countries give the forecast real, local site cost and recruitment data.
Platinum Award winner, EUCROF 2026, ranked first for clinical innovation and data strategy.
You talk directly to the COO and head of clinical operations, not an account manager reading a template quote back to you.
A network of employed CRAs and project leads, not subcontractors, gives every forecast real site-grant and recruitment data 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, the scope decisions that set the size, and therefore the cost, of any high risk device programme.
Eclevar manages RegenLab's PMCF programme 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. »
Most overruns are not surprises, they are preventable. They come from budgets set on rules of thumb before real costing: CRO quotes that exclude site grants, pass-through costs surfaced mid-execution, and recruitment timelines anchored to investigator optimism rather than historical site performance. By the time the true number appears, the PMCF plan is often already a binding commitment to the Notified Body.
Four dominate: site grants, which vary widely across France, Germany, the UK, Italy, Spain and Eastern Europe; CRO effort priced per role and hour across project management, monitoring, data management, biostatistics and medical writing; pass-through costs such as ethics and IRB fees, courier, customs and device kit shipment; and recruitment duration, which multiplies monitoring and management cost when it slips.
Once a PMCF plan or clinical investigation design is submitted under EU MDR Article 62 or Article 74, it becomes a financial and operational commitment that is expensive to redesign. Forecasting cost, sites and recruitment before feasibility lets you right-size the protocol, choose countries deliberately and set a credible budget while the design is still free to change.
Investigator estimates are consistently optimistic, so a realistic forecast is anchored to historical site performance, not PI memory. Eclevar models recruitment as a range with P10, P50 and P90 confidence intervals and Swift, Base and Conservative scenarios, so the board sees a credible worst case rather than a single number that assumes everything goes right.
Many CRO proposals price only the CRO's own effort and apply a rough multiplier for sites, or leave site grants and pass-through costs to be surfaced during execution. A defensible forecast itemises country-specific site tariffs and every pass-through line from the start, so the number you approve is the number you pay.
They are three parallel views of the same trial. Swift is a lean, registry-led design at a low site-cost assumption for a budget-constrained minimum viable study; Base is the most realistic full-scope forecast at median site rates; Conservative uses higher site rates, intensive monitoring and full HTA and payer work to give the board a credible worst-case risk envelope.
Eclevar parses your PMCF plan or synopsis, then produces parallel cost, site and recruitment forecasts from benchmarked European rate cards and hospital tariffs built on seven years of delivery data. A former Notified Body reviewer checks the design's defensibility and a head of clinical operations pressure-tests site and recruitment realism, so the estimate is both financially and regulatorily sound. See how we deliver as a specialist medical device CRO.
Send us your PMCF plan or synopsis and get a forecast of cost, sites and recruitment, in Swift, Base and Conservative scenarios, before your first feasibility round.
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