No decision in clinical development has a longer downstream impact than country and site selection. Every timeline you commit to, every budget you defend, every recruitment projection you present to your board – these are ultimately grounded in feasibility assumptions. If those assumptions are optimistic, the consequences show up months later, when there is no inexpensive way to fix them.

Database-driven feasibility exercises, in which sites self-report patient volume and competing study load, are a known source of optimistic bias. Sites that want work say yes. Sites that are overloaded say yes. The sponsor receives a set of numbers that look plausible and then encounters reality during site initiation.

APICES approaches feasibility differently. Our recommendations are based on direct investigator relationships and current operational data – what sites are actually enrolling, what their site staff capacity looks like today, and what their recent performance on comparable studies has been. This produces a smaller list of recommended sites, with higher confidence in each one.

What Feasibility Actually Covers

Country and site feasibility at APICES covers more than patient availability estimates. A complete feasibility assessment addresses six interconnected questions:

• Can your target patient population be reached at the scale and speed required by your protocol?
• Which European countries can activate within your timeline, given current regulatory and ethics submission lead times?
• Which specific sites have the infrastructure, therapeutic expertise, and staff capacity to deliver per your protocol requirements?
• What are the realistic per-country and per-site recruitment rates, based on comparable studies – not registry self-assessments?
• What are the cost drivers in each country, and how do they affect your budget assumptions?
• What are the operational risks in your current country and site plan, and how can they be mitigated before study start?

These questions are answered together, not as separate workstreams. Protocol design, country strategy, site selection, and operational planning are reviewed in an integrated feasibility process that reflects how the study will actually run.

Feasibility as an Execution Decision

Feasibility studies are sometimes treated as a due diligence step before a CRO bid – a document to have, not a decision to make. This misunderstands the function. Feasibility is the point at which you decide what is realistic. Everything committed after that – contracts, timelines, headcount, site activation sequences – depends on the quality of that decision.

APICES performs feasibility in direct connection with clinical strategy, study design, and clinical operations. Feasibility insights feed into protocol development before criteria are locked. If eligibility criteria are too narrow for the identified patient population, we say so at the design stage – not after three months of underenrollment.

Where your study operates across multiple European countries, feasibility assessments are country-specific, not aggregated. Regulatory approval timelines, ethics committee behaviour, and site performance vary significantly between Spain, Germany, France, Italy, and the Netherlands. A single aggregated recruitment estimate obscures the variation that determines whether your study hits its milestones.

Feasibility for Biotech, Pharma, and Medtech Sponsors

For early-stage biotech sponsors, feasibility often determines which CRO can credibly deliver a first-in-human or Phase II study within a 12- to 18-month window. The key questions are: which countries can be activated quickly, which sites have the infrastructure for the compound type, and whether the patient population assumption can survive contact with site-level reality.

For pharma sponsors, feasibility in later-stage programs involves managing competing study load across established site networks, aligning country strategy with payer access requirements, and ensuring that Phase III enrollment projections are defensible to internal governance boards.

For medical device sponsors, feasibility intersects with MDR Article 62 requirements and the specific investigator expertise and device infrastructure available at European sites.

What You Can Expect

• Country-by-country recommendation with regulatory and ethics submission outlook
• Named candidate sites with current performance data, not registry estimates
• Realistic recruitment projections by country and site, with underlying assumptions documented
• Per-patient cost estimates and key budget drivers by country
• Recommended start-up sequence with activation milestones
• Risk assessment covering the key operational threats to your timeline

Frequently Asked Questions

How is APICES feasibility different from a database query?

We work with sites we are currently engaged with and base recommendations on actual ongoing performance – not on legacy registry data. Site recommendations are named, with delivery history.

Which European countries does APICES cover?

Direct experience in Spain, France, Germany, Italy, the Netherlands, the UK, and selected experience in Belgium, Portugal, Poland, Czech Republic, and Hungary depending on indication.

What does a feasibility deliverable include?

A country-by-country recommendation with timelines, regulatory and ethics outlook, named candidate sites, recruitment outlook, per-patient cost estimates, and a recommended start-up sequence.

How long does feasibility take?

For a multi-country oncology Phase II study, plan 4–6 weeks from kick-off to feasibility deliverable. Tight-timeline biotech engagements can compress this to 2–3 weeks with focused scope.

Can feasibility be done before a CRO selection?

Yes. We do standalone feasibility work for sponsors comparing CROs or pressure-testing internal assumptions before issuing an RFP.