Blog
How to Expand Clinical Trials into New Countries
A Strategic Guide for Pharma Leaders
Ian Pemberton, VP Clinical Operations
Gary White, Head of Clinical FSP - Go to Market
Aug 18, 2025

Unlock New Markets. Accelerate Development. Improve Patient Access.

As clinical development grows increasingly complex and competitive, expanding trials into new countries is no longer optional—it’s essential. Whether your goal is to improve patient diversity, accelerate timelines, or meet local regulatory requirements, global expansion delivers powerful advantages.

But success demands more than ambition. It requires deep local knowledge, regulatory expertise, and robust operational infrastructure.

At IQVIA, we help sponsors navigate this complexity with precision and confidence.

Watch our recent webinar to explore how global trial expansion can drive success in your clinical development strategy.

Why Global Expansion Matters Now

Pharmaceutical companies are expanding clinical trials into new geographies to:

  • Access more diverse patient populations
  • Accelerate recruitment for complex protocols
  • Reduce operational costs
  • Meet local regulatory data requirements
  • Leverage AI and digital tools for smarter execution
  • Benefit from regulatory harmonisation (e.g., EU CTR)

10 Critical Factors to Evaluate Before Launching in a New Country

Before you expand, make sure your target country is ready. IQVIA recommends assessing:

  1. Country Feasibility – Is the country suitable for your protocol?
  2. Site Identification – Are there high-performing, experienced sites?
  3. Patient Recruitment & Retention – What are the local healthcare access and cultural considerations?
  4. Regulatory & Ethics Requirements – Are you prepared for local compliance?
  5. Data Management & Compliance – Are you aligned with GDPR and other privacy laws?
  6. Resourcing – Can you secure skilled, culturally aligned staff?
  7. Logistics & Supplies – Is the supply chain reliable and compliant?
  8. Cultural & Language Fit – Will language or norms impact recruitment or data?
  9. Clinical Infrastructure – Does the country have the right systems in place?
  10. Contracting & Payments – Are you ready for local financial processes?

FSO vs. FSP: Choosing the Right Delivery Model

  • Full-Service Offering (FSO): Ideal for smaller sponsors or those new to global trials.
  • Functional Service Provision (FSP): Best for large pharma with in-house capabilities needing modular support.

IQVIA supports both models—tailored to your needs.

Smarter Planning with Predictive Tools

Use GenAI-powered enrolment modelling to:

  • Forecast patient availability
  • Identify recruitment risks
  • Optimise country and site selection

Our tools help you make faster, more informed decisions—reducing delays and improving trial outcomes.

Local Expertise. Global Reach.

From regulatory navigation to site enablement and logistics, IQVIA combines global infrastructure with local insight. We help you:

  • Avoid customs and contracting delays
  • Support sites with eConsent, eSource, and Health-grade GenAI®
  • Ensure data quality and compliance across all regions

Ready to Expand Your Clinical Trials?

IQVIA has supported trials in over 100 countries across every major therapeutic area. Whether you're launching your first global study or scaling an existing programme, we’re here to help.

Let’s talk about your global trial strategy.

Related solutions

Contact Us