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Kendle’s recent acquisition of IC-Research provides us with a base of operations in the eighth largest country in the world and the fourth largest population in Latin America. This means that we now offer coverage across more Latin American countries than any other global CRO, with seven offices in six countries representing 80 percent of the region’s population.
Similar to other countries in Latin America, a significant proportion of the population in Argentina is under 14 years old (27 percent), so there is great interest in and potential for pediatric clinical research, particularly in areas such as asthma, infectious diseases and vaccines.
Most medical centers in Argentina are concentrated in Buenos Aires, Rosario and Cordoba where patients tend to be more affluent and participation in clinical trials may offer more access than usual to medical treatment.
In 2004, more than 100 trials were performed in Argentina (twice as many as 1999). And two out of three of these trials were in Phase III.
Regulatory and quality assurance
Argentina has a well-established regulatory process based on ICH GCP. Ethics Committee and Ministry of Health approval take 24-26 weeks, with excellent recruitment and retention. Also, the United States Food and Drug Administration and the local Ministry of Health (ANMAT) have inspected clinical trials conducted in Argentina with extremely positive results.
Broad therapeutic expertise
Osteoporosis – Argentina is one of the key places in the world in which to perform osteoporosis clinical research. It is consistently among the top global enrollers and delivers the highest quality data. Two of its sites have been audited by the FDA with excellent results.
Cardiovascular – Argentina is an extremely important center for cardiovascular and metabolic research also, with pivotal Phase III trials conducted in all major indications (Congestive Heart Failure, Hypertension, Acute Coronary Syndrome, Dyslipidemia, Metabolic Syndrome, Diabetes, etc.)
Rheumatology (Psoriatic Arthritis, Osteoarthritis) – Extremely qualified sites performing multinational Phase II-III studies with high enrollment rates and high quality data.
Pneumology (Pediatric Asthma)
Diabetes/Endocrinology (Type II Diabetes, Growth Hormone Disorder/ TS, Acromegaly)
Urology (Benign Prostatic Hyperplasia)
Gastrointestinal (Gastroesophageal Reflux Disease – GERD)
Neurology (Multiple Sclerosis and Parkinson's) |
