LATAM: A Model for FSP Success

The global expansion of clinical research sites has more than doubled over the past two decades in response to increasing trial complexity, patient enrollment challenges, and the need to access diverse sites, patients, and evolving skill requirements. This, coupled with the potential of innovation, technology, and AI-enabled solutions to boost productivity, has led many biopharma companies to adopt functional service provider (FSP) delivery models for accessing global talent worldwide.

To keep pace and expand global reach, the clinical research sector is increasingly recognizing the untapped potential of talent in emerging regions, particularly Latin America (LATAM).  

Projections for the LATAM clinical trials market indicate significant growth, with an expected increase from USD 2.17 billion in 2024 to USD 3.23 billion by 2029, representing a compound annual growth rate (CAGR) of 8.2%. As of April 2024, Brazil leads the region with approximately 10,000 registered clinical studies, followed closely by Mexico (5,000) and Argentina (4,000).¹ 

A hub for clinical, regulatory and biometrics innovation

LATAM offers a unique combination of advantages, positioning the region as a hub for various clinical, regulatory, and biometric functions. Countries in LATAM such as Brazil, Argentina and Mexico are emerging as prominent global clinical research hubs due to their cost-effectiveness and the presence of talented professionals. The advantageous time zone proximity to the United States and a talent pool that is increasingly proficient in English lends itself to stronger collaborative communication and quicker project turnaround times, providing an outsourcing advantage.

Recognizing this potential, Parexel began building a clinical research infrastructure in LATAM in 2002 as part of its global network, tapping into the benefits of the region’s educated, motivated workforce, improved regulatory landscape and financial resilience. 

Parexel now has the highest retention rates in the region in comparison to our closest competitors.²  Claudia Yvette Cravioto Guzman, Sr. Director, FSP Clinical Operations and Mexico, General Manager Business Administration (GMBA), who is based in Mexico, attributes this to the strong relationships Parexel has cultivated by closely working with the clinical research team and providing training and a career path. This approach better positions customers for success as opportunities in the region continue to emerge, she adds. 

Success story: transitioning a clinical hub to Argentina

A notable success story in LATAM is highlighted by Dmitry Kolosov, project leader in statistical programming at Parexel, who played a pivotal role in supporting a top five pharma company in transitioning its largest, well-established clinical hub from Russia to Argentina. After more than 10 years of operation in Russia a significant part of the team transferred to Argentina and within a year Parexel had hired and onboarded more than double the original staff.  

Relocating to Argentina from Russia, Dmitry worked to build the hub, providing training, support and resources to help implement processes that resulted in increased efficiency and productivity. According to Dmitry, creating a supportive environment and encouraging a healthy work-life balance has contributed to higher employee satisfaction and retention rates. He emphasizes that the strong motivation, talent, work ethic and collaborative nature of the team define the hub’s culture. “The rich academic environment given the local research centers and area universities, including The University of Buenos Aires and the University of La Plata, contribute to the attractiveness of the local, skilled talent pool,” said Dmitry. 

The importance of local presence and leadership in LATAM

The evolving regulatory landscape in LATAM has created a growing demand for specialized regulatory FSP services. As countries in the region continue to harmonize their regulations with international standards, there's an increasing need for local experts who can navigate these complex regulatory environments. According to Anita Patel, regional head of Parexel’s regulatory team (located in Brazil), by leveraging local regulatory expertise and relationships with health authorities, the team is able to navigate complex regulatory pathways, resulting in faster-than-average approval timelines and simultaneous launches in key LATAM markets.

Having a local presence and leadership that is based in the LATAM region strengthens the relationships that Parexel builds with local talent, regulatory authorities based in the area, local associations and the global network of sites overall, according to Mariana Bei, Sr. Director of Clinical Operations and Brazil GMBA at Parexel, who is based in Sao Paulo.  

One example is Parexel’s collaborative efforts with other local CROs and its partnership with Brazil's well-structured CRO association, the Brazilian Association of Clinical Research Representative Organizations (ABRACRO). 

Together, they advocate for clinical research advancement and better regulatory frameworks, including ABRACRO’s recent work in implementing the promising new clinical research law in Brazil (The Brazilian Clinical Research Law 14.874/24). Released in Aug 2024, the law aims to streamline the assessment process for clinical trials and reduce regulatory timelines, supporting innovation and Brazil's competitiveness in the global research landscape.

Setting the stage for FSP outsourcing success

The growth of LATAM's clinical research sector is further bolstered by the region's thriving startup ecosystem. As of 2021, LATAM was the world's fastest-growing region in startup funding, with more technology investments in 2022 than in the previous decade combined. These investments have fostered a tech-savvy workforce with skills easily transferable to clinical research.³ 

As the industry continues to shift towards flexible FSP models, LATAM's educated and motivated workforce, improved regulatory landscape, and burgeoning technology sector offer new avenues for outsourcing. This unique combination of factors positions LATAM as an ideal partner for evolving customer needs in an ever-changing market, making it a model for FSP success in the global clinical research landscape.

References

1. Smith, J (June 2024).  Regulatory Affairs Professionals Society. Latin America Roundup: Brazil’s clinical trials law strengthens participant protections | RAPS
2. LinkedIn Talent Insights Data, October 2024.
3.  Forbes, (June 2023). Latin America Shows Investment Promise—But Challenges Remain.  https://www.forbes.com/sites/forbesfinancecouncil/2023/06/13/latin-america-shows-investment-promise-but-challenges-remain/

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