Latin America is a prime region for conducting clinical trials offering large patient pools that generate rapid trial enrollment, high retention rates and a lack of competitive trials in all therapeutic areas. However, regulation in Latin America varies from country to country and approval timelines can cause trial delays and data inconsistencies. To avoid this, sponsors must be prepared for regulatory and GCP coordination with various international governing bodies and ethical agencies.

 

 

Our CLINICAL Services

 

• Study Design

• Study Feasibility

• Regulatory Affairs

• Study Start Up

• Local Project Management

• Clinical Trial Management

• Pharmacovigilance

• Quality Assurance

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EXPERTISE AREAS

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• Protocol writing and design support

• Project Start-up: EC/IRB submission, MoH approval

• Patient Recruitment Strategies

• Full Monitoring activities

• Project Management activities

• Scientific and Technical Support Due Diligence

• Training & Professional Development

• SOP reviewed and writing

• Document Translations  

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THERAPEUTIC AREAS EXPERIENCE

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• Oncogenomic & Translational

• Genetic Testing Studies

• Oncology

• Endocrinology

• Cardiology

• Psychiatry

• Circulatory

• Infections/Parasitic Diseases

• Immune System

• Gynecology

• Musculoskeletal

• Hematology

• Gastroenterology

• Medical Devices