Why Sponsors and CROs Should Consider Sites in Puerto Rico

When considering sites, Sponsors and CROs should keep Puerto Rico in mind. There are many benefits to partnering with Puerto Rican sites: Their optimal geographic location, the favorable regulatory environment, outstanding human capital, and a top-tier business atmosphere. All the benefits offered to sites in the rest of the United States apply also to Puerto Rico.

Location

Puerto Rico is the epicenter of the Americas, located just in between North and South America. The flight time from New York to San Juan is three and a half hours, and the flight time from Miami to San Juan is a mere two and a half hours. Puerto Rico is not as far from the rest of the US as it may seem, which makes travel as simple as many other domestic flights. Flight time aside, travel is also made easier because US travelers do not need a passport in order to get to Puerto Rico; it is also the largest non-contiguous foreign trade zone in the US. Puerto Rico has an average year-round temperature of 84 degrees Fahrenheit and the languages spoken there are English and Spanish. The strategic geographic location makes it easy to access US expertise, and if needed, there is an ability to access Central and South America for trials that require multiple sites.

Advantageous Regulatory Environment

Puerto Rican sites can take advantage of a world-class business environment, benefiting from the US regulatory, legal, financial and political environment. In Puerto Rico, all US FDA regulations applicable to the conduct of clinical trials apply since it is a US territory. There is a local FDA office in San Juan that can provide advice and accept dossiers both in English and in Spanish, which can be a major selling point to many markets in the Americas. Although eligibility for potential tax incentives is subject to assessment by the Puerto Rican Government, there are financial benefits for choosing Puerto Rico for studies. There is a 4% or 8% fixed corporate income tax rate and 50% tax credit for eligible R&D activities.

Experienced Sites and Exceptional Human Capital

Puerto Rican research sites have decades of regulatory compliance expertise and an educated, skilled, and bilingual workforce. Puerto Rico has many types of sites including dedicated research centers, hospitals and clinics. They handle difficult therapeutic areas, as their areas of expertise include oncology, immunology, cardiovascular, diabetes, infectious diseases, neurology and dermatology. Puerto Rico also has a high disease prevalence with a population that is underinsured and has limited access to the latest medicines. Another benefit is that Puerto Rico has a very diverse patient population, making it an ideal place for clinical research.

Conclusion

Many people have preconceived notions about working with sites in Puerto Rico. In reality, a lot of these are misconceptions. These misconceptions include slow response times, Puerto Rico being a foreign regulatory body, travelers needing a passport to travel to Puerto Rico, poor site quality, lengthy travel time, and a higher cost to send staff there. Since Puerto Rico is a US territory, that makes things like travel and regulations much easier than anticipated. There are plenty of resources available to those who choose to work with sites in Puerto Rico, and the general methods and processes are the same as in the rest of the US. Clinical research quality in Puerto Rico is equivalent to the mainland United States, so one can expect similar response times in both places.