Kendle in Mexico

With more than 107 million people, Mexico has the second largest population in Latin America. Almost a quarter of its population (28 million) is found in the capital, Mexico City, and its metropolitan area. Most medical centers are concentrated in Mexico City, Monterrey and Guadalajara, where patients are more affluent and participation in clinical trials may offer much better medical treatment than patients usually receive.

Quality of Data

Mexico has a well established regulatory process based on ICH GCP. Ethics Committee and Ministry of Health (MoH) approvals take 14-18 weeks. Our office in Mexico has participated in many successful trials, most notably contributing more than 50 percent of the patients for a pivotal Phase III trial of an approved NDA (Aloxi™ – fastest approval of a standard review NDA in 2003).

Access to specialized patient populations

Osteoporosis
Mexico is one of the key world countries in which to perform Osteoporosis clinical research. Two of its key sites have been audited by the FDA with excellent results and Mexico is always among the top world enrollers, maintaining the highest quality of data.

Cardiovascular and Metabolic
Mexico is an extremely important location in the conduct of cardiovascular and also metabolic research. Most pivotal Phase III trails in all major indications (Congestive Heart Failure, Hypertension, Acute Coronary Syndrome, Dyslipidemia, Metabolic Syndrome, Diabetes, etc.) have been performed in the country, and recruitment and data quality have always rated among the highest in the world.

Pediatric Trials
Similar to other countries in Latin America, a large percentage of the population is less than 15 years of age, making Mexico a great location for the conduct of pediatric clinical research. The country has always provided key sites for quality enrollment in areas such as asthma, infectious diseases and vaccines.

Rheumatology
Rheumatic disease has been always a very important area of research in Mexico. There are extremely qualified sites that have vast experience performing multinational Phase II-III studies, with high enrollment rates and quality of data.

Clinical Data Management

Kendle’s Biometrics unit utilizes a global network to deliver the highest quality data through four offices in the US, two in Europe, one in Australia and one in Mexico. Our Mexico location provides a lower cost, high-quality option for a significant proportion of our customers’ data management work. If you’re based in the United States, Mexico operates in the same time zones, enabling real time communication. We offer the following clinical data management capabilities in Mexico:

Data management and statistics

• Protocol design
• Clinical data management
• Biostatistical analyses
• Medical writing
• Clinical study reports

Culturally appropriate services that comply with international and local regulations

• Specialized regional regulatory affairs
• Proactive clinical quality assurance that helps prevent errors from the start
• Multilingual personnel
• Bilingual Investigator Meetings, forming strong site teams and sponsor-investigator relationships
• Feasibility and site selection by country experts
• Site contract management and payments, combining local and international law and accounting to meet local site needs