7 Questions Every Biotech CEO Should Ask Before Outsourcing an Oncology Trial in Europe

If you’re a biotech CEO weighing where and with whom to run oncology clinical trials in Europe, the margin for error is thin. Even though the EU’s Clinical Trials Regulation (CTR 536/2014) has standardized many processes via CTIS, country-by-country realities still drive start-up speed, site performance, and overall cost of capital. Below are the seven questions that separate smooth European oncology programs from costly course corrections.

1. Which countries will actually recruit fastest for my indication and design?

Europe is not homogeneous for oncology enrollment. In particular, recent ecosystem analysis performed by EFPIA show significant differences in time-to-enrol and first-patient-in/last-patient-in dynamics across the EEA, with Spain, Poland and Denmark consistently among the fastest for oncology recruitment, performing similarly to the UK in like-for-like comparisons.

For late-phase or larger oncology programs, consider a hub-and-spoke mix:

• High-throughput anchors: Spain, Poland, Denmark – strong oncology site networks and proven speed.
• Scale and KOL density: France, Germany, Italy, Netherlands. 
• Acceleration/rescue capacity (CEE): Czech Republic, Hungary, Romania, Bulgaria – often excellent “rescue” geographies if your initial countries underperform.

Action for CEOs: Ask your prospective CRO to show protocol-specific historic enrolment curves and screen-fail/major deviation rates by tumor type and line of therapy in those countries – not generic slideware.

2. What are the true start-up timelines under the EU CTR via CTIS and what variance should I budget?

CTR 536/2014 harmonizes submission through CTIS, splitting review into Part I (core scientific/benefit-risk) and Part II (country-specific ethics/site docs). Theoretical clocks are: validation 10–15 days, assessment 45 days (extendable), and 5 days for national decisions. Substantial modifications have analogous, slightly shorter clocks.

In practice, executives should plan a buffer. Experienced sponsors/CROs report actual approvals often run ~80–120 days depending on clock stops and holiday periods across Member States.

Action for CEOs: Demand an evidence-backed country-by-country Gantt that distinguishes (a) regulatory clock, (b) common clock-stop triggers in your tumor type (e.g., radiology substantiation, tissue logistics), and (c) site-contracting bottlenecks that fall outside CTR.

3. How will our partner operationalize CTIS to minimize clock stops and keep Part I/Part II synchronized?

CTIS is more than a portal – it changes ways of working:

• Parallelization: Part II can run in parallel to Part I. Well-run programs pre-align ethics and privacy documents to avoid Part II delays.
• Documentation discipline: Oncology files are heavy (biomarker plans, imaging charter, safety stopping rules). Expect your CRO to maintain submission-ready QC with issue logs aligned to the Reporting Member State (rMS) and Member States Concerned (MSCs).
• Public transparency: CTIS public portal and the clinical trial map (launched 2025) increase visibility of your trial footprint – good for awareness, but it also raises the bar on consistency of public documents.

Action for CEOs: Ask to see your partner’s CTIS playbook (templates for RFIs, roles during validation/assessment, redaction strategy for the public domain, governance for transitions).

4. Are there imaging, radiation, or radiopharmaceutical nuances that will slow us down?

Oncology trials frequently involve ionizing radiation (diagnostic imaging or theranostics). Under CTR you still must satisfy national radiation protection rules – and these differ. For example, Germany introduced new radiation-protection approval rules effective July 1, 2025, with specific procedures via BfArM/PEI. These changes can affect timelines if not pre-planned.

For radiopharmaceuticals, EU projects and specialist societies continue to flag heterogeneity in dosimetry assessment and approvals across Member States, calling for further harmonization – meaning country-specific expertise still matters.

Action for CEOs: Confirm your CRO’s country-level radiation approval matrix (who does what, required dossiers, typical clock stops) and their central imaging/radiation QA experience.

5. Is our companion diagnostic/biomarker pathway IVDR-ready?

If your program relies on an IVD/companion diagnostic, the IVDR (EU 2017/746) transitional arrangements and 2024 amendments affect both device availability and notified body capacity. The Commission and agencies have clarified extended transition pathways and obligations (e.g., IVDR-compliant QMS, notified body agreements by specific dates; staged deadlines into 2027/2028 by risk class). Failure to align can delay screening and site activation.

Action for CEOs: Require a diagnostics readiness plan: device classification, current certification status, notified body timelines, bridging strategy if your CDx vendor slips, and site-level logistics for tissue handling.

6. How will we handle GDPR and cross-border data flows, especially if analytics sit in the US?

Oncology trials generate sensitive data (genomics, imaging, longitudinal outcomes). For transatlantic transfers, the EU-U.S. Data Privacy Framework (DPF) provides an adequacy basis (in force since July 10, 2023), recently upheld by the EU General Court (Sept 3, 2025) – reducing legal uncertainty for U.S. hosting/analytics when your vendor is DPF-certified. 

Action for CEOs: Confirm whether your CRO/vendors are DPF-certified (or have robust SCCs + TIAs), how pseudonymization is implemented, and how data residency is managed for imaging/genomics pipelines.

7. If we include the UK in a pan-European design, what changes?

The UK operates outside CTR/CTIS (MHRA pathway), but remains a valuable oncology market with large NHS patient pools. Ongoing UK reforms aim to cut set-up from ~9 months to ~10 weeks via standardized contracting and operational streamlining – useful for pilots and expansion cohorts. Ensure your partner can run dual submissions (UK+EU) without duplicative effort.

Action for CEOs: Ask for a UK/EU parallel start-up plan that reuses artifacts, aligns safety reporting across regimes, and leverages NHS research infrastructure for recruitment.

Country Shortlist Cheat-Sheet

• Primary engines for speed + volume (solid tumors): Spain, Poland, Denmark; add Germany/Italy/France for breadth and KOL coverage.
• Rescue/scale in CEE: Czech Republic, Hungary, Romania, Bulgaria (contracting pragmatism, motivated sites).
• Add the UK when NHS access or rapid pilot activation is strategic.

Always validate with recent feasibility – tumor type, line of therapy, SOC shifts, and competing trials can change the picture quarter-to-quarter.

CRO Questions You Should Ask

1. CTIS performance: “Show me your last 10 oncology CTIS submissions: countries, clock-stop reasons, days to approval vs theoretical clocks.”
2. Recruitment evidence: “Provide country-level enrollment curves and screen-fail rates for trials analogous to ours (phase, line of therapy, biomarker).”
3. Radiation/radiopharm readiness: “Map required radiation approvals per country for our imaging/theranostic plan, with typical timelines and mitigations.” 
4. IVDR/CDx plan: “Confirm device class, certification path, notified body status, and contingency if certification slips.”
5. Data protection posture: “Are your data processors DPF-certified or covered by SCCs/TIAs, and how is pseudonymization implemented end-to-end?”
6. UK parallelization: “Demonstrate a harmonized EU+UK start-up plan avoiding duplicate work and divergent safety workflows.”
7. Transparency & metrics: “Commit to an executive dashboard (weekly) tracking: approvals by state, activated sites, randomization pace vs forecast, screen-fail root causes, and mitigation ETA.”

Executive Takeaways

• Pick countries by data, not hearsay – EEA oncology recruitment leaders include Spain, Poland, Denmark (often alongside the UK), but feasibility must reflect your tumor biology and competition map.
• Plan beyond the theoretical CTR clocks. Expect 80–120 days in real life and de-risk with RFI prevention and country-specific ethics artifacts.
• Don’t overlook specialty regulators. Radiation and radiopharmaceutical rules can be the hidden long pole – pre-clear with experts.
• Future-proof data flows. The EU-U.S. DPF (and recent court backing) lowers transfer risk, but vendor due diligence remains non-negotiable.
• Use the UK strategically for speed and access, with a parallel submission strategy.

References

1. European Medicines Agency (EMA). Clinical Trials Regulation (EU) No 536/2014 and the Clinical Trials Information System (CTIS). Available at: https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials-regulation. Accessed September 2025.
2. European Commission. Clinical Trials Information System: Sponsor Handbook and Guidance Documents. Available at: https://health.ec.europa.eu/clinical-trials/ctis_en. Accessed September 2025.
3. EFPIA. Patients, Science and the Future of Europe: Clinical Trials in Europe 2024 Report. Available at: https://www.efpia.eu.
4. Spanish Clinical Research Network (SCReN). Annual Report 2024 – Clinical Trial Recruitment in Oncology. Available at: https://www.scren.es.
5. Danish Cancer Society Research Center. Oncology Clinical Research Activity in Denmark, 2023–2024. Available at: https://www.cancer.dk.
6. Federal Institute for Drugs and Medical Devices (BfArM). New Radiation Protection Rules for Clinical Trials. Effective July 1, 2025. Available at: https://www.bfarm.de.
7. Paul-Ehrlich-Institut (PEI). Clinical Trials with Radiopharmaceuticals: Guidance and Approvals. Available at: https://www.pei.de.
8. European Association of Nuclear Medicine (EANM). Position Paper on Harmonization of Dosimetry Requirements in Radiopharmaceutical Clinical Trials. Eur J Nucl Med Mol Imaging. 2024.
9. European Commission. Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR) (consolidated text with 2024 amendment). Available at: https://health.ec.europa.eu/system/files/2024-01/reg_2017_746_en.pdf.
10. MedTech Europe. IVDR Transition Status Update 2025. Available at: https://www.medtecheurope.org.
11. European Commission. EU-U.S. Data Privacy Framework: Adequacy Decision. July 10, 2023. Available at: https://ec.europa.eu/commission/presscorner/detail/en/ip_23_3721.
12. European General Court. Judgment in Case T-456/23: Validity of the EU-U.S. Data Privacy Framework. 3 September 2025.
13. European Data Protection Board (EDPB). Guidance on Health Research and Pseudonymization under GDPR. 2024. Available at: https://edpb.europa.eu.
14. Medicines and Healthcare products Regulatory Agency (MHRA). Pro-Innovation Clinical Trials Regulation: UK Implementation Plan 2023–2025. Available at: https://www.gov.uk/mhra.
15. UK Department of Health and Social Care. UK Clinical Trial Reform: Faster Approvals and NHS Access. Policy Paper, 2024.