Why Clinical Trials in Latin America?

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BRIEF OVERVIEW

  • 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)

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