Full-Service Contract Research Organization of Latin America

Phases II & III Studies

Background

The CRO of Latin America

Navigating the complexities of Phases II and III of your clinical trial can be challenging. Having a local partner that knows how to keep everything on track, on time and on budget is vital to the success of your study in Latin America.

Our local-based knowledge, proven expertise and highly personalized services provide the solutions you need to meet multiple milestones, solve recruitment challenges, monitor safety and effectiveness.

Background

Cohortias Network

Global Mindset, Regional Execution

As part of our customized approach to clinical trial strategy, we formed an extensive network of local experts across South America, United States and Europe.

This trusted network of investigators, study personnel and high-performing sites works together to provide you with accurate and optimized execution that streamlines day-to-day clinical trial work.

Our network operates using a peer-to-peer model that provides guidance in each one of our clinical studies, which are executed regionally by our team in Argentina, Brazil, Colombia and Mexico.

Cohortias Network

Patient Enrollment

Latin American Patient Population

Latin America has wide diversity of races and ethnicities which mirrors the wider market.

Strong physician/patient bond that strengthens patients’ compliance and retention in the trial.

Latin Americans live within large urban areas, which means easier recruitment efforts and simplified trial logistics.  This translates in a major source of cost savings.

LatAm is home to dense urban areas; in fact, the United Nations has referred to it as the most urbanized region of the world, where 90% of the people in the Southern Cone region:

  • São Paulo (20 million),
  • Mexico City (32 million)
  • Buenos Aires (13.6 million)
  • Rio de Janeiro (12 million)

They all rank in the top 25 largest metropolitan centers in the world.

Source: United Nations

Patient Enrollment

LatAm Capabilities

An Active, But Far From Saturated, Trial Market

In terms of its capacity to accommodate clinical trials, Latin America is, potentially, at an ideal stage: it has the requisite staff, facilities, regulations and quality standards, but is not yet saturated with trials.

Currently there are 1,427 active industry studies in progress across ten countries in the region, and six countries (Brazil, Mexico, Argentina, Chile, Peru and Colombia) account for nearly 90% of all Latin American trials.

Latin American governments have been consistently promoting regulations that adhere to legal and ethical international standards, and facilities are routinely audited for compliance.

LatAm Capabilities

Cost Effectiveness

Affordable Clinical Trials – Phases II and III

Decreased travel to and from sites (densely populated cities). Multiple academic, public and private hospitals in small areas. Salaries and Professional fees for Researchers and medical procedures involved in research highly competitive compared to those of USA/Australia/Europe.

Reference Sites concentrate less prevalent diseases, helping optimize costs and simplify site selection.

When running multi-country studies in the region, translation costs are minimized since Spanish is the prevailing language spoken in the region followed by Portuguese (Brazil).

Cost Effectiveness

Local knowledge makes the difference

Clinical Trials
in Latin America

Having an international coverage with customized solutions by local-based teams across Latin America, helps us deliver added value to Sponsors who intend to conduct multinational studies in a speedy and flexible manner with the highest quality.

Our team experienced at managing all aspects of Phase II and Phase III clinical trials. We offer a broad range of services that allow us to provide capacity and experience in clinical trial management. We ensure fast patient recruitment, provide high quality collected data, best industry timelines, very competitive pricing and a rapid start-up process.

Services Included

Medical Writing

  • Clinical Study Protocol
  • Clinical Investigational Plan
  • Clinical Evaluation of Medical Devices
  • Patient Information/Informed Consent Form
  • Investigator‘s Brochure
  • Investigational Medicinal Product Dossier
  • Clinical Study Report

Clinical Operations

  • Site Selection
  • Contract and finance management
  • Clinical Monitoring including risk-based and remote monitoring
  • Project Management of national and international clinical studies
  • Training for CRAs and Investigators

Regulatory Affairs

  • Full Regulatory Affairs Support
  • Dossier Pre-submission Assessment and Gap Analysis
  • Competent Authority and Ethics Committee submissions
  • Full medicinal product dossier development Marketing Authorization Applications
  • Full post-authorization support
  • Consulting services

Pharmacovigilance

  • Full Pharmacovigilance Support
  • Clinical safety services, supported with fully E2B and CFR21 compliant safety database
  • Medical monitoring 24/7 services
  • Full post-authorization support including local safety services

Data Management

  • Set-up of CRFs
  • Set-up and validation of clinical data base
  • Statistical programming
  • Medical coding
  • Data cleaning
  • Data mapping

Biostatistics

  • Biostatistical Analysis (Interim or Final)
  • Centralized statistical monitoring
  • Randomization
  • Simple Size Calculation
  • Statistical Consultancy and Planning

Quality Assurance

  • Consultancy
  • Investigational Site Audits
  • System Audits
  • Risk Analysis
  • Support for Establishment of Quality Management or Quality Risk Management System
  • GCP/GVP audits

Patient Engagement

  • Study branding
  • Recruitment advertising and collateral materials
  • Investigator referral source outreach
  • Patient advocacy group outreach
  • Site recruitment toolkit and resources
  • Study Website development and translations
  • Social media outreach

Therapeutic Area Expertise

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