Latin America in the Global Clinical Trials Arena
Latin America (LATAM) is quickly gaining momentum as a strategic region for global clinical trials development. With improvements in regulatory systems, growing alignment with international standards, and a diverse patient population with limited prior treatment exposure, LATAM is becoming a key destination for sponsors seeking to speed up timelines without compromising data quality or ethical standards.
For pharmaceutical and biotech companies looking to expand beyond saturated regions such as North America and Western Europe, LATAM offers a compelling mix of agility, scale, and scientific excellence. Regulatory agencies such as Brazil’s ANVISA have reinforced their procedures and now operate in full alignment with ICH GCP, FDA, and EMA requirements, making the region a trusted source of globally accepted clinical data.
In this article, we explore Latin America’s rise in global clinical research, the evolution of its regulatory environment, and how experienced partners like Synvia can help sponsors unlock the region’s full potential, from protocol development to regulatory submission.
LATAM: A Region of Opportunity and Scale
Latin America presents a unique blend of size, diversity, and operational efficiency that few other regions can match in today’s clinical research environment. Countries such as Brazil, Mexico, Argentina, and Colombia are transforming Latin America into a prime zone for clinical trials, supported by expanding healthcare
infrastructure, growing investments in research, and large populations eager for access to innovative treatments.
Key advantages for global sponsors include:
- Ethnic and genetic diversity: The region’s population diversity improves the external validity of study results and supports the global demand for more inclusive data.
- Faster recruitment and high retention: Low competition for participants and centralized care structures enable quicker enrollment and stronger compliance with protocols.
- Lower operational costs: Compared to North America and Europe, LATAM provides significant savings in site management, staffing, logistics, and patient support while maintaining high-quality standards.
- Greater regulatory responsiveness: Agencies are becoming increasingly professional, transparent, and responsive to industry needs, with timelines aligning more closely with international benchmarks.
For sponsors aiming to balance cost, speed, and quality, Latin America is an attractive setting for both early and late-phase trials, including pivotal studies for product registration. The region’s evolution, especially in Brazil, positions it as a key part of global clinical development strategies.
ANVISA: A Gateway to Global Drug Development and Clinical Trials
At the heart of Latin America’s growing influence in clinical trials is ANVISA (Brazil’s National Health Surveillance Agency). Over the past decade, ANVISA has gone through significant transformation, modernizing its regulatory framework, increasing transparency, and aligning with the highest international standards. Today, it plays a central role in positioning LATAM as a trusted region for international clinical development.
Key attributes that make ANVISA a regulatory leader:
- Full alignment with ICH-GCP, FDA, and EMA standards
- Active member of the International Council for Harmonisation (ICH)
- Participation in governance decisions and in proposing topics for the harmonization of technical requirements for pharmaceutical products
- Priority framework for registration, post-registration petitions, and prior authorization in clinical drug research, including rare diseases
For sponsors, this means that clinical data generated in Brazil is not only of high scientific and ethical quality, but also globally relevant and submission-ready for agencies like the EMA and FDA. ANVISA’s regulatory maturity brings predictability, efficiency, and credibility, making Brazil the most robust entry point into the broader LATAM region.
More than a national authority, ANVISA is becoming a regional benchmark, setting standards for harmonized regulations, scientific rigor, and international cooperation across Latin America.
EMA and FDA: Compatibility with LATAM Data
One of the most important questions for global sponsors considering conducting studies in Latin America is: Will the data be accepted by international regulatory agencies?
The answer is clear: Yes, the data from clinical trials conducted in Latin America can be accepted by the FDA and EMA, provided they strictly follow ICH-GCP and the specific requirements of each regulatory agency
Synvia: A Trusted LATAM Partner for Global Sponsors
Conducting clinical trials in Latin America requires more than a local presence, it demands deep regulatory insight, operational excellence, and full alignment with global standards.
With over 20 years of experience, Synvia is one of the most trusted and capable CROs in Latin America, providing full-service support to sponsors across all phases of clinical development.
Headquartered in Brazil and connected throughout the region, Synvia bridges LATAM’s growing research capabilities with the demands of international sponsors.
Synvia’s key differentiators include:
- Multisite infrastructure in São Paulo and Campinas, with 162 dedicated beds, on-site analytical labs, and advanced patient monitoring
- Comprehensive regulatory support for agencies such as ANVISA (Brazil), COFEPRIS (Mexico), and INVIMA (Colombia)
- Strict compliance with ICH-GCP, ISO 17025, ALCOA+, and other international quality frameworks
- Centralized patient recruitment via a proprietary database of over 150,000 pre-screened participants, supported by AI-powered outreach
- Integrated Synvia eCRF platform and data management systems compliant with 21 CFR Part 11 and CDISC
- Experienced, cross-functional teams fluent in both local and global regulatory requirements
Synvia goes beyond execution, it delivers strategic guidance every step of the way. From site selection to regulatory submission, from biostatistics to medical writing, Synvia ensures reliable, high-quality outcomes that meet the expectations of both sponsors and regulators.
For global companies seeking to expand into Latin America with confidence and control, Synvia is the ideal entry point, backed by a proven track record and a reputation for excellence.
Why Latin America Should Be Part of Your Clinical Trials Development Strategy
Latin America is no longer just an emerging region for clinical trials, it has become a strategic pillar for pharmaceutical and biotech companies aiming to accelerate timelines, reduce costs, and access high-quality, diverse data.
With regulatory maturity, untapped patient populations, expanding infrastructure, and international alignment, LATAM provides a competitive edge in today’s demanding development environment.
Agencies such as ANVISA are helping position Brazil, and the region as a whole, as a reliable source of data that meets FDA and EMA expectations. With the right partner, such as Synvia, sponsors can confidently conduct audit-ready, globally compliant trials fully aligned with international standards.
For companies exploring new regions beyond traditional markets, Latin America is not just an alternative, it is a smart, scalable, and strategic choice.
Ready to explore Latin America for your next clinical trial?
Contact Synvia today and discover how we can support your research from protocol to submission with precision, speed, and regulatory excellence.
📩 comercial.cro@synvia.com