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Planning a clinical trial in Europe requires careful budgeting and a thorough understanding of regulatory requirements. With the EU Medical Device Regulation (MDR 2017/745) in effect, clinical investigations for high-risk devices (Class III and some Class IIb) are now mandatory. Each country also maintains its own approval process, which adds complexity to timelines and costs.

Sponsors must secure both Competent Authority and Ethics Committee approvals and, even when working with a CRO, appoint a legal representative within the EU. These requirements create a challenging environment where preparation and financial planning are essential to avoid delays and unexpected expenses.

Below we outline the major cost categories to consider and provide typical ranges to guide your budgeting process.

Cost Categories

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When budgeting for a European pre-market clinical trial, it is essential to break costs into clear categories. This not only increases transparency for sponsors and investors but also minimizes the risk of overlooking significant expenses.

Regulatory & Start-up

- MDR submissions and translations, required in the local language of each country.
- Ethics committee fees for almost all EU countries.
- Site contracts, GDPR compliance, and EU representative fees.
- Preparation of essential documents: protocol, Investigator’s Brochure (IB), and device dossier.

CRO Project Management

- Central project manager responsible for overall coordination.
- Country-specific clinical leads ensuring local execution.
- CRO overhead, often calculated per site per month.

Site & Patient Costs

- Site start-up: €5,000 to €7,000 per site, covering contracts and staff training.
- Per patient: €2,000 to €5,000 depending on procedure complexity and reimbursement needs.
- Investigator meetings and training.
- Follow-up visits, with long-term follow-up increasingly required under MDR.

Monitoring & Clinical Operations

- On-site monitoring: €1,500 to €2,000 per CRA visit.
- Travel expenses: €350 to €500 depending on location.
- Remote monitoring options, often more cost-efficient.

Device Supply & Logistics

- CE-mark investigational labeling in multiple languages.
- Distribution, warehousing, and returns across Europe.
- Additional site tooling or kits if needed.

Data Management & Statistics

- Electronic Data Capture (EDC) system setup and licensing, GDPR-compliant.
- eTMF and CTMS platforms, including licensing fees.
- Data cleaning and query management.
- Biostatistics for interim analyses and the final Clinical Study Report (CSR).

Safety & Medical Monitoring

- Serious Adverse Event (SAE) reporting and vigilance as required by MDR.
- Annual safety reports.
- Data Safety Monitoring Board (DSMB) oversight for high-risk devices.

Pass-Through Costs

- Central laboratories or imaging core labs, where applicable.
- Translation of all patient-facing materials into local languages.
- Long-term archiving (MDR and GDPR require at least 10 years).
- Insurance, mandatory for all patients and varying by country.

Contingency (10–20%)

- Protocol amendments and additional regulatory requests are common, so a 10–20 percent contingency is necessary to safeguard the budget.

Total Typical Ranges

The final budget for a European pre-market clinical trial depends heavily on study size, complexity, number of countries involved, and length of follow-up. Below are typical ranges.

Small Feasibility Study
- 50 to 100 patients.
- 4 to 8 sites in 1 to 2 countries.
- Shorter-term follow-up.
- Typical budget: several hundred thousand euros.

Pivotal MDR Trial

- 80 to 150 patients.
- 8 to 12 sites across 3 to 5 countries.
- 2 to 3 years of follow-up.

Complex Implantable or High-Risk Devices

- Cardiology, orthopedics, or neurology devices, often involving imaging and extended follow-up.
- Intensive monitoring and DSMB oversight.

EU-Specific Cost Drivers

Sponsors must also account for EU-specific elements that directly impact budgets:

Translations of regulatory documents and all patient materials

Insurance, mandatory for each patient with rates that vary by country

GDPR compliance, requiring higher IT and data protection costs

Multi-country submissions, each involving separate Competent Authority and Ethics Committee fees.

Example Calculations

\n- Scenario 1: €35,00 per patient - 100 patients × 2 countries × 4 sites × 24 months follow-up = €672,000
- Scenario 2: €15,00 per patient - 100 patients × 4 countries × 10 sites × 30 months follow-up = €1,800,000 \n

These examples illustrate how geography, site numbers, and follow-up duration all multiply the total investment required.

How Qserve CRO Can Help

Budgeting and managing a European pre-market clinical trial is complex. Qserve CRO brings deep experience in multi-country EU trials, combining regulatory expertise, project management, and clinical operations. Our budgeting tool makes it easy to calculate and manage costs, and if you prefer to take on certain aspects of the trial yourself, they can be removed from the budget sheet.

Qserve CRO can fully or partially support your trial, from submissions and site coordination to patient recruitment, GDPR compliance, and cost-optimization strategies, all while ensuring high-quality data. By partnering with us, sponsors can minimize delays, avoid unexpected costs, and confidently navigate the European clinical trial landscape.

Ready to streamline your EU clinical trial? Contact Qserve CRO today to discover how our expertise can help you plan, budget, and execute your next trial efficiently and compliantly.

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Meet Celien van Lochem – Qserve CRO’s Business Development Manager