Country Selection for Research Sites
Selecting the right countries for a clinical trial is one of the most critical factors influencing the success, speed, and cost-effectiveness of the study. Poor country selection can lead to delays, regulatory hurdles, recruitment failures, and increased costs, while an optimized strategy can accelerate approvals, improve data quality, and enhance patient diversity.
Strategic Country Selection is Key to Trial Success
There is no one-size fits all approach to country selection for clinical trials. WEP works closely with Sponsors to understand their overall clinical trial objectives and available budget/resources, i.e. what they plan to do and how they plan to do it. We then leverage data-driven decision-making, regulatory expertise, and operational insights to create a strategic country selection plan that will help Sponsors select the most suitable countries for their clinical research sites.
We Build our Country Selection Plan Based on the Following:
Regulatory & Ethical Considerations
- Analyze regulatory landscapes to ensure compliance with agencies like the FDA, EMA, MHRA, PMDA, Health Canada, and CFDA.
- Assess approval timelines for Clinical Trial Applications (CTAs), INDs, and Ethics Committee approvals.
- Help Sponsors navigate local regulatory complexities, such as GDPR compliance (Europe) or specific data protection laws in different regions.
Patient Recruitment & Population Insights
- Use real-world data (RWD), epidemiological databases, and historical recruitment rates to identify countries with the right patient population.
- Assess disease prevalence, standard of care, and treatment-naïve patient availability to optimize site selection.
- Consider competition from ongoing trials that may impact recruitment efforts.
Site Feasibility & Investigator Network
- Conduct site feasibility assessments to evaluate:
- Investigator experience & site infrastructure
- Historical recruitment & retention performance
- Regulatory compliance track record
- Utilize our established investigator networks and maintain site performance databases to ensure efficient selection.
Cost & Budget Considerations
- Evaluate trial costs in different countries, including:
- Site start-up costs
- Investigator fees
- Regulatory submission fees
- Patient compensation & logistics
- Recommend cost-effective regions while balancing quality and efficiency.
Logistical & Operational Feasibility
- Assess supply chain & drug import/export regulations to ensure investigational product (IP) shipment feasibility.
- Consider cold chain requirements, storage capacity, and customs clearance timelines.
- Consider language & cultural factors to ensure study materials (e.g., informed consent forms) can be effectively translated.
Competitive Intelligence & Trial Density Analysis
- Analyze competitive trial activity to determine which countries may be saturated with similar studies.
- Recommend less competitive markets where recruitment may be easier.
- Use benchmarking tools to assess trial success rates in different regions.
Standard of Care & Medical Infrastructure
- Evaluate the healthcare system and standard of care (SoC) in each country.
- Countries with more advanced medical infrastructure may provide higher-quality data but could have more competition for patients.
- In some cases, countries with less developed SoC may be ideal for studies that offer access to innovative treatments.
Risk Assessment & Political Stability
- Assess political, economic, and legal risks that may impact trial operations.
- Monitor potential policy changes, healthcare funding shifts, and geopolitical issues.
Diversity & Inclusion Considerations
- Regulatory bodies (e.g., FDA, EMA) are increasingly requiring diverse patient populations.
- Help Sponsors identify underrepresented regions to ensure compliance with diversity mandates.
Hybrid Trial and Mobile Nursing Capabilities
- WEP’s Mobile Nursing solution eases the burdens placed on all study stakeholders by allowing patients to participate in clinical trials from the comfort of their own homes.
- WEP works closely with Sponsors to understand if and how this solution can be mobilized in certain strategic countries to help optimize recruitment and patient retention.
- Visit our mobile nursing page for more information.