By Gary White, Ian Pemberton, and Claire Rielly, IQVIA 

November 21, 2025 | The patient-centered approach that has come into favor for planning and conducting clinical trials is, without question, improving care for trial participants. However, combined with other industry trends, including the proliferation of rare disease studies with much smaller patient pools, it is causing trial protocols to become more complex and is creating challenges in patient recruitment, which can lead to costly delays in a competitive and challenging macroeconomic environment.  

As they work to maximize research and development investments, clinical trial sponsors are exploring the return on investment they may accrue from reaching beyond long-established target countries and sites, which if done correctly will reduce program costs while providing access to more diverse patient populations. As many mid-size pharmaceutical companies navigate the rapidly evolving market, they need to continually assess where to dedicate resources and investments to drive growth while dictating their company’s direction. But how do mid-size sponsors confidently select the right countries for expansion, accelerate study start-up and access new patients if they don’t have all the necessary internal resources and finances in place?  

In this “do more with less” R&D scenario, clinical trial sponsors are increasingly relying on contract research organizations to help them meet their nuanced needs at holistic and local levels and to provide strategic guidance to ensure access to the resources and expertise needed to start trials in new countries. 

Below, we dive into what’s behind the push for geographic expansion and the critical items that mid-size pharmaceuticals need to address to successfully navigate new geographies, patient experiences, regulations, R&D infrastructures and processes, etc., to optimize clinical trial delivery and drug development timelines.  

Influencing Factors for Widening the Net   

The CRO industry plays a pivotal role in enabling drug developers to conduct clinical trials in an optimal manner across multiple countries, which expands patient access to innovative treatments and care. At the same time, regulators are increasingly supporting digital health technologies in trials, allowing sponsors to adopt decentralized and hybrid designs that boost recruitment and engagement across regions. And efforts like the EU Clinical Trial Regulation are harmonizing requirements and streamlining approvals across borders. 

Expanding trials into more regions may afford several advantages, including:  

• Provision of care to previously underrepresented groups. 
• Flexible or expedited pathways to regulatory approval of new treatments. 
• Reduced operational costs in less affluent locations. 
• Increased global sales footprints.  

Scoring Country Readiness: Determine Where to Expand  

Once they have decided to expand into a new country, how do trial sponsors, especially mid-size pharmas, do it effectively?  

The critical first step is to have a holistic view of the potential risks or pitfalls of conducting a trial in a specific country, which requires an understanding of the local R&D history, regulatory nuances and more. What works in one country may not work in another, and it is vital to understand why.  

Recently, sponsors have increasingly relied on evidence-driven methodologies to fine-tune the country selection process. With artificial intelligence-assisted scientific literature review, it is feasible to define metrics for a country’s suitability for clinical trials based on such parameters as operational and clinical infrastructure and patient availability. With such insights, sponsors can make data-informed decisions as to which countries represent feasible targets for trial expansion. Findings should indicate:  

• What country-level factors consistently drive successful clinical trial execution. 
• Which countries are “ready” for clinical trials. 
• Which countries have untapped potential for integration into global clinical programs. 
• How sponsors can apply these insights to optimize short- and long-term country strategies.  

Key Country Considerations for Trial Feasibility and Start-up: Boxes to Check  

Once countries that warrant consideration for trial expansion have been identified, sponsors will need to evaluate several variables to efficiently move the planning process forward. For example, traditional feasibility analyses may indicate how many patients an individual site might secure for a single trial in a specific country. But how much deeper can we go to understand how additional factors, such as the local standard of care, patients’ previous care experiences and competing trials, could impact trial enrollment? From there, what’s necessary to mitigate these potential barriers? 

Prior experience and deep insights into global trials and country-specific dynamics are critical, especially for sponsors that lack local familiarity. Anticipating real-world barriers and operational nuances allows sponsors to proactively address challenges and tailor solutions to high-risk areas, such as: 

• Patient recruitment and retention 

Most trial designs include robust patient recruitment and enrollment strategies. However, taking further steps to understand how these outreach efforts may be received in specific countries and specific communities within these countries can strengthen patient access and engagement.  

Ensuring trial materials are available in appropriate languages and account for cultural sensitivities can be extremely important in some countries. For example, if we want to reach patients in sub-Saharan African villages, do we know how information should be presented and what messaging commonly included in trial materials should or should not be included?  

Another step is to gauge how local infrastructure may impact outreach. For example, in some low-to-middle income countries, healthcare infrastructure may be limited, making it important to work closely with local healthcare providers, public health officials and/or community leaders to facilitate access to patient populations.  

How sites run trials is unique to local geography, culture, and broader healthcare frameworks. It is helpful for sponsors to have access to in-depth intelligence and the perspectives of various types of sites, such as professional research sites, hospitals, teaching hospitals, etc., which experienced CRO partners and/or site management organizations can often provide. Having a more holistic understanding of what happens at the individual site level within various countries allows sponsors to tailor designs and solutions to optimize site performance and related patient engagement.  

• Payments, contracting and local logistics  

Understanding local tax laws and legal requirements/expectations for site and vendor contracts and having experience with payment nuances can help sponsors avoid another long-standing obstacle that can create significant delays and/or frustrations at the site level. For example, in Nigeria, currency and exchange issues can cause problems when paying fees to the regulator and having up-front understanding of local practices and requirements can help avoid issues and costly delays.  

In certain regions, particularly those with limited infrastructure, navigating logistics and supply chains can pose significant challenges that risk delaying trial timelines. For example, delivering therapies to patients in rural Africa requires meticulous planning to manage risks and ensure continuity. This includes real-time tracking, comprehensive documentation and maintaining strict temperature controls. Success depends on seamless coordination among sponsors, CROs, transport providers, local public health agencies and regulators. 

Logistical considerations in China include its requirement that any Investigational Medicinal Product have at least a 12-month shelf life to clear customs. This has significant impact on a wide range of IMPs that have shorter expiry times. 

• Local staff resourcing  

When setting up a trial in a new country, sponsors will wish to secure local staff with appropriate skills and qualifications. However, it is also important to ensure adherence to local laws, practices, guidelines, etc. For example, in certain countries in the Middle East and North Africa, clinical research organizations are required to present a CRO license to provide services locally. In Ghana, clinical research associates must be local residents who have completed the Ghana Food and Drugs Authority Good Clinical Practice training.  

• Data management and compliance  

As clinical trials expand globally and data privacy standards tighten, staying current with evolving regional regulations is essential. However, tracking and interpreting new or updated data governance requirements across countries is resource intensive. Partnering with a CRO that actively monitors global data protection laws and offers strategic compliance guidance can significantly reduce risk and complexity. Whether working under the General Protection Data Regulation in Europe, the General Data Protection Law in Brazil or NMPA data management guidelines in China, it is critical that requirements are understood, and steps are taken for compliance long before a trial starts. 

• Regulatory and ethics requirements  

The wide variation in regulatory and ethical requirements across countries makes a deep understanding of local and regional frameworks critical for effective trial delivery and for avoiding costly and impactful start-up delays and operational risks.  

Beyond knowing which documents are required and who oversees submissions, sponsors must also navigate more nuanced, country-specific expectations, many of which may not be immediately apparent to those unfamiliar with the local landscape. These include informal practices, unwritten expectations and evolving interpretations of guidance that can impact timelines and compliance. Scenarios that illustrate the extent of country-by-country variation and the importance of local expertise when entering new markets include: 

• In Saudi Arabia, ethics reviews may require sponsors to account for cultural and religious practices in trial planning and design. 
• In Peru, a U.S.-based sponsor would need to know whether the local regulatory agency accepts U.S. dollars or whether the company needs to set up a local bank account. 
• The Korean Society for Laboratory Medicine has issued sample collection and storage guidelines for specific procedures involving human biological materials, such as venous blood collection.
• In Greece, an EU member country, to secure an import license, a sponsor would need to understand local customs requirements and how to integrate them into the larger EU-CTR submission documentation.  

The EU-CTR process and implementation continues to evolve with many countries still adapting their application and interpretation of the regulation. This requires sponsors and CROs to anticipate potential inconsistencies and changes and how to best address them. For example, authorities in some countries have deviated from EU-level guidance to either authorize or reject applications, while other EU countries have taken a different position. For mid-size sponsors aiming to expand into Europe for the first or only time, it can be difficult to execute when you simply do not have the requisite experience. The slightest submission error costs significant time, money and resources. 

It is possible for sponsors to turn to an in-country CRO to manage and address local requirements; however, the process would need to be recreated in each country with a different local CRO. The added layers of siloed communications within multiple CROs will almost certainly create inefficiencies. 

For CROs with a global footprint, it is possible to create a centralized framework of all local regulation needs per country within a trial by working with local regulatory leads to monitor country-level requirements. This might require maintaining a regulatory intelligence database, monitoring country intelligence regarding all details for accelerated trial start-up and evaluating previous experiences with similar submissions and lessons learned or employing a tech-enabled global translation solution to ensure all regulatory and start-up documents are appropriate for local stakeholder review.  

Sponsors may also reduce costs and drive efficiencies with a centralized approach that moves selected activities or resources to less expensive locations. These teams can be assigned tasks that do not require direct site interaction or country-specific regulatory authority engagement. This could include drafting and reviewing Informed Consent Forms based on global templates, preparing core regulatory documents (e.g., 1572 for the U.S. Food and Drug Administration) and managing essential document tracking and version control. 

The fine balance of effort between local, regional and centralized team members with defined roles and responsibilities and seamless communication can proactively advance clinical trials while addressing evolving regulations and local practices in countries of interest.  

Critical Connectivity  

With the daily cost of clinical trial delays ranging from $600,000 to over $8 million, maximizing every investment is critical, especially for mid-size pharmaceutical sponsors. Success hinges on the ability to align all operational elements into a cohesive, well-coordinated strategy. All components must work in unison to ensure that the mission-critical requirements for country expansion and trial start-up are met with speed, precision and minimal risk. 

Early engagement with CROs, including identification and planning in areas where trial sponsors need to bridge gaps in knowledge and resources to optimize their global R&D efforts, can be highly beneficial. An orchestrated collaboration with partners providing highly specialized functional expertise and solutions can help minimize the surprises that may come when navigating the nuances of patient-centered R&D in new countries and sites while ensuring a holistic view of all global trial activities.