When planning a real-world evidence (RWE) study, teams naturally focus on design, objectives/endpoints, sample sizes, stakeholder alignment, and publication goals. But experience shows that one of the earliest and most decisive choices has nothing to do with methodology. It is where you choose to run the study.
Country selection can be driven by numerous factors, including stakeholder needs, drug uptake, and participant selection, but it can also be the hidden factor that determines whether a program runs on schedule before fielding begins. Regulatory and ethics-committee timelines vary significantly across and within countries; contracting requirements differ by country, country region, and site, and qualitative work triggers are country-dependent. A poorly chosen country mix can introduce months of avoidable delays, bloated budgets, and missed publication windows.
The Global RWE Reality: Timelines Are Global, But Delays Are Local
Ethics & IRB Approval Is Just the First Gate
Almost every RWE program must pass through ethics or an institutional review board (IRB) review and approval. Because studies may span multiple countries, a single slow region can hold back the entire program, meaning country choice becomes a strategic timeline decision, not just a feasibility checkbox.
Regional Snapshot: When “Global” Means Very Different
North America
- Web-based studies in the United States and Canada can often clear IRB review and launch within one to two months, utilizing a central IRB approach.
- But site-based studies? That’s a very different timeline: IRB review plus contracting can stretch out over three to five months or more, especially in the U.S., where site contracting is frequently the biggest bottleneck.
Europe
- Europe may be discussed as a block, but operationally, it behaves like a single country.
- Germany and the UK stand out as the fastest environments for web-based programs because neither requires ethics review for that approach.
- France is moderate yet predictable.
- Italy and Spain often rank among the slowest in Western Europe. Italy, for example, may need three to seven months just to secure ethics approval for patient-centered studies, with contracting (for site-based studies) adding another three to seven months.
Within Europe alone, a study’s launch timeline can range from a few weeks to half a year, depending entirely on the countries selected.
Central America
- Mexico and Argentina typically deliver efficient approvals (usually one to three months).
- Brazil, by contrast, remains one of the slower markets in the region due to extended ethics review cycles.
APAC ( Asia-Pacific)
- Australia has historically been challenging, until recently.
- South Korea ranks among the fastest globally – across both web and site-based modalities.
- Japan is often among the slowest, with ethics reviews usually lasting six to eight months, regardless of study type.
Qualitative Work: A Critical (and Overlooked Trigger)
Qualitative work, such as cognitive testing, concept elicitation, and exploratory interviews, often triggers ethical requirements. But not everywhere.
Only three of the above-mentioned markets allow qualitative activity without prior ethics review: Germany, the UK, and Italy (for HCP-only studies). This creates a strategic path: begin qualitative work early in these “fast-lane” markets, refine instruments while ethics processes run elsewhere, and avoid timeline delays.
In this context, country choice transforms qualitative work from a potential bottleneck into a timeline accelerator.
Case Study: How Australia Went From Bottleneck to Competitive Advantage
We recently conducted a multi-country observational study that included Australia. Historically, we’d anticipated up to four months for institutional review there. Once we submitted all required materials, the process encountered multiple rounds of review questions due to misunderstandings about observational design, staff turnover, and repeated clarification requests. Internal resource demands mounted, timelines slipped, and risk to downstream deliverables increased.
At that point, we pivoted, engaging a vendor whose structure was better suited to modern RWE: IRIS Ethics.
Result: Within one week of vendor onboarding and 10 days after review initiation, we received full approval. A process that historically spanned months was condensed into days.
Why it worked:
- The review committee at IRIS Ethics operated on an on-demand schedule rather than scheduled site-based IRB review meetings.
- Selected reviewers were experienced in observational and mixed-methods research.
- The submission process was streamlined and focused only on essential documentation.
- Communication was proactive, transparent, and efficient.
The outcome reaffirmed our core thesis: with the right operational approach, country choice is not just a feasibility consideration; it’s a strategic accelerator.
What This Means for Your RWE Strategy: Practical Guidance
Based on our benchmarking and real-world program experience, the following patterns consistently emerge:
Markets that accelerate RWE timelines:
- Germany (especially for web-based studies; qual or quant)
- United Kingdom (no EC requirement for web-based studies, qual or quant)
- Mexico (efficient ethics pathways)
- South Korea (fast across modalities)
- Australia (now, when using IRIS Ethics for web-based or site-based studies)
Markets that pose high timeline risk:
- Italy (regional and site-based variability leading to long ethics review + contracting cycles)
- Spain (regional variability and often extended reviews)
- Brazil (slower ethics pathways)
- Japan (six to eight months typical)
If your study includes early-phase qualitative work, starting in Germany, the UK, or Italy (for HCP-only), it may allow faster instrument development while allowing slower markets time to clear review.
This strategic orchestration of country choice and study modality can transform long start-up cycles into efficient, predictable launch timelines and protect your scientific and commercial milestones.
Conclusion: Country Choice is Not an Operational Detail, It’s an RWE Strategy
In RWE, success depends on factors that begin long before the first participant enrolls. It lies in operational foresight and strategic planning.
Country choice determines start-up speed, resource burden, cost, and ultimately whether you meet scientific and business milestones on time.
Approach country selection as a strategic lever. When you align country mix, study modality, vendor selection, and regulatory realities, you don’t just design a study; you architect RWE success.
Author
Danny Wolin
SVP, Real World Evidence
Danny Wolin has over 25 years of RWE and regulatory affairs experience in the pharmaceutical industry. He has a proven track record of collaborative partnership in the design and leadership of qualitative and quantitative RWE studies across multiple therapeutic areas that help inform important healthcare decisions.
