Why Clinical Trials in Latin America?
- Area: 21,069,051 sq. km
- Population: 569 million (est 2008)
- GNI 3,554.6 (Bil US$)
- GNI per capita: US$ 5,885
- Almost all countries are democratic presidential republics
- Governments broadening general access to healthcare
- Longer life expectancy (around 74 years)
- High fertility rates
- High infant mortality rate between 15 to 18%
- Pharma market value of $80bn in 2013, up from $50bn in 2010
- Only 2 languages: Spanish and Portuguese.
OUTSTANDING ATTRIBUTES FOR CLINICAL RESEARCH
- Large urban patient populations, close to 80% concentrated in a few urban areas.
- Disease profiles and therapeutic standards resembling those of the US and Europe
- Incidence of many diseases comparable to more developed countries
- Treatment-naive patients available in all therapeutic areas
- Tradition of high quality medical care
- Regulations and laws for clinical research aligned with international standards
- Smaller number of clinical trials competing for the same patients, which guarantees more patients per site
- Seasonal reversal, enabling continuous enrolment
- Only 2 languages needed for all study documents: Spanish and Portuguese, which reduces translation costs and time needed to prepare documents for start-up
- Approval timelines similar to Eastern Europe when local knowledge is applied
- Skilled MDs in all therapeutics areas, working not only private facilities but also public hospitals
- High patient enrollment and retention rates due to close, trustful patient-doctor relationships.
- Highly experienced investigators, with GCP training
- Proven high-quality data. Most of the clinical research conducted in the region is part of multinational, industry-sponsored clinical trial efforts for FDA and/or EMA submissions.
- Experience with FDA/ EMA, local regulatory inspections and sponsor audits
- Laboratory staff with IATA certification and experience in PK sampling
- Investigators & research staff with English language literacy
- Expertise in working with IWRS and EDC systems
- Quality proven regional vendors for support services (drug distribution, sample transportation, cold-chain logistics, etc.)
- High standard communications and IT
- Similar time Zone as the USA/Europe (0 – 5 hours difference)