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UK Clinical Research Organisation for US Biotech Companies

Looking for a UK-based CRO to support your European clinical development programme? TCR Solutions partners with US biotech and pharmaceutical companies to deliver high-quality clinical trials across the UK and Europe.

From EMA regulatory submissions to EU site selection and trial management, we provide the local expertise US sponsors need to navigate the European clinical landscape with confidence.

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Why US Biotech Companies Choose UK CROs

For US biotech companies planning clinical trials in Europe, partnering with a UK-based CRO offers distinct advantages:

  • EMA Regulatory Expertise: Navigate European Medicines Agency requirements with a team experienced in EU regulatory submissions, scientific advice procedures, and marketing authorisation applications
  • Access to European Investigator Sites: Leverage established relationships with clinical sites across the UK and EU, accelerating site selection and patient recruitment
  • FDA + EMA Alignment: Design studies that satisfy both FDA and EMA requirements, supporting global development strategies and avoiding costly protocol amendments
  • Time Zone Coverage: Maintain continuous progress on your programme with a UK team working while your US office is offline
  • Cost-Effective Trial Delivery: Competitive site costs and operational efficiencies without compromising on quality or regulatory compliance
UK CRO for US biotech

Clinical Research Services for US Sponsors

TCR Solutions offers a comprehensive range of clinical research services tailored to the needs of US biotech companies operating in Europe:

European Regulatory Affairs

European Regulatory Affairs

  • EMA scientific advice and protocol assistance
  • Clinical Trial Application (CTA) preparation and submission
  • EU Clinical Trials Regulation (CTR) compliance
  • Regulatory strategy aligned with FDA requirements for global submissions
Data Management & Biostatistics

Data Management & Biostatistics

  • EDC setup and data management compliant with ICH-GCP
  • Statistical analysis plans designed for FDA and EMA submissions
  • Interim analyses and Data Safety Monitoring Board support
  • Clinical study reports meeting regulatory requirements

Discuss Your European Trial

European CRO for US companies

How We Work with US Biotech Companies

TCR Solutions operates as an extension of your team. We understand that US sponsors need a CRO partner who can bridge the gap between US headquarters and European operations.

Transatlantic Communication
Regular calls scheduled to accommodate US East Coast time zones, with dedicated project managers available during overlapping hours.

Flexible Engagement Models
Whether you need full-service trial management or functional support in specific areas like regulatory or data management, we tailor our services to your requirements.

Transparent Reporting
Real-time visibility into trial progress, milestones, and budget through regular reporting aligned with your internal processes.

Therapeutic Experience

Our team has deep expertise across a range of therapeutic areas, with particular strength in:

  • Oncology and immuno-oncology
  • Rare diseases and orphan drug development
  • Cell and gene therapy
  • CNS and neurology
  • Infectious diseases

Ready to Discuss Your European Clinical Programme?

If you’re a US biotech company planning clinical trials in Europe, we’d welcome the opportunity to discuss how TCR Solutions can support your programme.

Get in touch to schedule a call with our team. We’ll discuss your development goals, timelines, and how our UK and European expertise can help you achieve them.