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Site Selection
- Pre-feasibility
- Environmental assessment
- Patient Journey Overview
- Sites Recommendation
- Sites Selection / Qualification visit
Monitoring Activities
- Site Initiation Visits (SIV)
- Interim Monitoring

Visits (IMV)
- Close-Out Visits (COV)
- Site Management
Startup/Regulatory
- Protocol and Investigator Brochure
- Informed Consent Form (ICF)
- CRF/eCRF
- Identify and Recruit Investigational Sites
- Qualify Sites
- Randomization Services
- Study Medication Management
- Management of Other Clinical Supplies
- Electronic Trial Master File
- Regulatory Gap Analysis & Submissions
- Ethical Submissions
Patient Recruitment
- Patient Support Program
- Medical monitor review for pre-screening
- Support for patient identification
- Engagement of sites and referral institutions
- Medical education and disease awareness initiatives
- Meaningful reduction of the gap between site activation and FPI
- Patient concierge services
Therapeutic Areas
- Rare Diseases
- Cell and Gene Therapy
- Oncology
- Infectious Diseases
- Hematology
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Commercialization
Expertise
Early Access
Commercialization
Regulatory Hosting
-Rare and Ultrarare Diseases

-High Complexity Diseases
- Post Trial Supply

- Patient Help Desk (PHD Program)

- Importation Support

- Brokerage Services

- Logistic Support
- Patient Support Program

- Diagnosis Support Program

- Pharmacovigilance

- Importation & Exportation Support

- Brokerage Services

- Logistic Support
- Market Authorization
- Sanitary Vigilance Support
- Pricing and Reimbursement
Quality Assurance
- Supply and Handling Controls
- Qualification, Audits, and Inspections
Why LATAM
Ethnically

Diverse Population
High Standard Regulation
Medical Infrastructure
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Empowering Progress in Healthcare

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