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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
- Ophthalmology
- Nephrology
- Neurology
- Cardiovascular
- GI and Hepatology
- Endocrinology
- Allergy and Respiratory
- Rheumatology
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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Untapped Opportunity
Careers
Empowering Progress in Healthcare

Our mission is to enact positive change for patients.

Come join our team!
Click the button below to learn more about open positions and send your CV:
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Contact
Please feel free to reach out!

You can send an e-mail to bd@odclifesciences.com
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Profile

Join date: Aug 3, 2024

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Leisa Hallett

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